Erica has a history of cardiac issues. She visits her doctor for a regular checkup and her doctor writes a new prescription to better control her heart disease. Unfortunately, her doctor didn't mention any instructions, except to take it once a day. Erica thanks her doctor and heads to the pharmacy. At the check-out counter, the clerk hands Erica her new prescription drug, in addition to three documents stapled to the bag that he says "will explain everything you need to know about your medication." Later on, while reviewing the materials at home, Erica is overwhelmed by the information, which is in fine print and difficult to understand. She is frustrated and confused, and tosses the documents in the trash.

This scenario is not uncommon. Research suggests that about 50 percent of Americans find it difficult to read health information.[i] Consumers who cannot find the information they need, or who do not understand the information because it is presented in a convoluted manner, are less likely to use it to prevent unnecessary medical errors. In Erica’s case, she could have ended up in the emergency room because she missed some basic warnings about her prescription. For example, one warning might have been that she should not chew the medication because it was an extended release capsule. Chewing the capsule could release the entire day’s dose at once, resulting in an unintended overdose.

We know that consumers are receiving information – sometimes too much information. Not only are consumers receiving pages of medication information, the information they receive is uncoordinated and sometimes conflicting. Some documents are written by the drug manufacturer, and others are written by pharmacies or another third party. Some medication information documents are FDA-approved and others are not.

The real question is – could medication information be presented in such a way that it would be more useful for consumers? The answer is a resounding “yes.” One study found that just 75 percent of consumer medication information met the minimum criteria for usefulness.[ii] That number might be impressive as a field goal percentage in the NBA, but for consumers it represents an unmet need for high quality medication information.

The U.S. Food and Drug Administration (FDA) has spent the past several years working with stakeholders to determine the most effective methods for conveying medication information. One overarching principle that has emerged from FDA’s engagement with the health care community is the need for a single, standardized document to replace the numerous existing documents. This document is identified as Patient Medication Information (PMI).

PMI creates an easier way for consumers to access and understand their medication information. By presenting the most salient pieces of information – including drug uses, warnings, side effects, and directions – on a single page that is easy to navigate, PMI can be a useful tool for enhancing treatments and preventing avoidable medication errors or side effects. PMI holds promise both for consumers and the broader health care system. For consumers, PMI could contribute to better outcomes and an overall improvement in patient experience. For health systems, PMI’s positive impact on medication adherence could improve performance on quality measures, such as hospital readmissions, that could lead to shared savings or other rewards.

Through a cooperative agreement, the Engelberg Center for Health Care Reform at the Brookings Institution has worked in collaboration with FDA over the past few years to convene a series of workshops focused on identifying best PMI practices – for example, how to make PMI both more usable and accessible.  Workshop participants identified several guiding principles for improving the content, format, and distribution of PMI.

PMI Guiding Principles

PMI content should be consumer-friendly. Expert stakeholders identified a lack of consumer-friendly information as one of the most important barriers to effectively communicating critical medication information. To fix this problem, the language used in PMI will need to be simplified, patient-centric, and understandable across the entire spectrum of health literacy levels. The types of information that should be included in PMI must be essential for taking a medication properly. Extraneous information, such as a discussion of previous treatments a consumer must have previously tried and failed before receiving the new prescription, may be more confusing than helpful.

The best PMI formats are simple and easy to navigate. Consumers don’t want to be given a technical-looking instruction manual when they pick up their prescriptions. Participants at the workshops generally agreed that it would be ideal to keep PMI to a single page. They also agreed that actionable headers that help consumers locate the information they are looking for are preferable to the question and answer format (e.g., “Uses” and “Directions” are more effective than “What does the drug treat?” and “How do I use the drug?”). There was consensus on the point that consumers will ultimately decide the best format.

Access to PMI will be bolstered by multiple channels of distribution. Paper is still the primary source of medication information, and is preferred by certain demographics. However, technology is revolutionizing the way consumers receive information. This is generally good for society, but it introduces some challenges, including the fact that consumers now have more access to information of questionable quality.  One method for ensuring access to consistent and high quality PMI would be to have a central repository for all PMI documents. This approach could support distribution of both printed and electronic PMI. Access to PMI could be further enhanced by making it available on smartphones and via email.

On July 1, the Center will convene a public meeting that will provide an opportunity for the health care community to discuss the issues mentioned above. Researchers will give an update on progress made since the previous meetings and share the lessons they learned from recent studies. Diverse stakeholders – including patient advocacy groups, providers, pharmacies, and drug manufacturers – will provide their perspectives on the future of PMI and assess their role in making high quality PMI a reality. 

There are many issues that need to be addressed in exploring the promise of PMI. However, one thing that participants at the July 1 meeting should remember is this: Keep it simple, stakeholders.

Please note that this Engelberg Center for Health Care Reform Health Policy Issue Brief first appeared in the Health Affairs Blog on July 31, 2014. Click here for the Health Affairs Blog version.

Abstract

Individual patient expanded access is a process by which patients can obtain investigational drugs that have not been approved by the Food and Drug Administration (FDA) outside of a clinical trial setting from biopharmaceutical companies when no other alternative therapy is available. Currently, no industry-wide structural principles exist to help companies navigate this process while balancing the needs of getting a drug to the market as quickly as possible with providing potentially life-saving treatment to individual patients. The Engelberg Center convened a stakeholder group to identify common themes and identify common principles related to expanded access, as none currently exist. The result was 4 A’s - Anticipation, Accessibility, Accountability, and Analysis – to help assist patients, providers, and companies with expanded access. Process and capacity building recommendations for the FDA also were proposed to assist companies with sustaining expanded access programs.

Call to Action: The Importance of Expanded Access Programs

Individual patient expanded access, sometimes termed “compassionate use,” refers to situations where access to a drug still in the development process is granted to patients on a case-by-case basis outside of a clinical trial, prior to completion of mandated clinical trials and approval by the Food and Drug Administration (FDA). This typically involves filing a single patient or emergency investigational new drug (IND) request with the Food and Drug Administration and voluntary release of the drug by the manufacturer. Generally, the following criteria must be met: there is reasonable expectation of meaningful benefit despite the absence of definitive clinical trial data, the patient has a serious or life-threatening condition, there are no comparable or satisfactory treatment alternatives, and there are no suitable clinical trials for the drug available to the patient. This form of expanded access, which is the focus of this paper, is different from the situation in which a drug is discharged to a large group of needy patients in the interval between successful phase 3 trials and presumed FDA approval, a strategy often termed a “treatment” IND or protocol, which was initially used in the 1980s for releasing zidovudine to patients with acquired immune deficiency syndrome.

The Engelberg Center for Health Care Reform at the Brookings Institution recently invited senior leaders from several pharmaceutical companies, two bioethicists, a senior FDA representative, and a patient advocate to share experiences and discuss organizational strategies related to expanded access (see acknowledgements). A driving factor for this meeting was a recent flurry of highly public cases of desperate patients seeking access to experimental drugs, which lead to social media campaigns and media coverage. Such cases included 7-year-old Josh Hardy (brincidofovir from Chimerix for disseminated adenovirus infection), 45-year-old Andrea Sloan (BMN673 from BioMarin for ovarian cancer), 41-year-old Nick Auden (pembrolizumab from Merck for melanoma), and 6-year-old Jack Fowler (intrathecal idursulfase from Shire for Hunter Syndrome). Expanded access requests to the FDA for new patients are increasing, from 1,000 patients nationwide in 2010 to more than 1,200 in 2012.[i] (This is likely an underestimate, since it does not include appeals made directly to companies.)

In the wake of these events, it became clear that many biopharmaceutical companies had varying experiences and policies related to such access. From the domestic regulatory standpoint, the FDA revised its expanded access regulations in 2009, which define criteria that must be met to authorize expanded access, list requirements for expanded access submissions, describe safeguards that will protect patients, and preserve the ability to develop meaningful data about the use of the drug. Biopharmaceutical companies typically face a complex global environment in which legal and regulatory frameworks can differ substantially. At the meeting, a senior FDA representative indicated the agency has approved over 99 percent of expanded access requests submitted via single patient or emergency INDs since 2009, suggesting the regulatory agency is not a major barrier to expanded access. As such, provided the access request is reasonably related to the potential benefits of the drug, the biopharmaceutical company is almost solely responsible for the decision and liability regarding whether to grant expanded access to an individual. Still, the public belief persists that the FDA is the main bottleneck that restricts access. In April 2014, Representative Morgan Griffith (R-VA) proposed H.R. 4475, The Compassionate Freedom of Choice Act of 2014, designed to restrict the FDA’s ability to prevent the use of investigational drugs in terminally ill patients. Similarly, some states have passed “Right to Try” legislation to reduce FDA oversight, but contains no requirement that companies must make drugs available.[ii]

The goal of our meeting was to identify common themes and possibly broad outlines to suggest industry-wide policies related to expanded access, as none currently exist. The group first discussed background issues related to expanded access and agreed on definitions. The meeting then focused on three topics. First, the group participants who play key roles in evaluating expanded access requests were invited to share narrative experiences in specific clinical cases, in an effort to lay the groundwork for trust and open discussion. Second, the group was asked to identify internal industry-specific structural barriers, such as the existence of clear procedures or tracking mechanisms within companies to handle requests. Finally, the participants reflected on situations in which expanded access may not be appropriate, or where regulatory barriers or liability concerns may hinder expanded access. This paper reflects the authors’ observations and assessment of the internal and external landscape, based upon information provided by the meeting participants.

Laying the Groundwork with Shared Experiences

The FDA allows companies to provide drugs and charge individual patients that do not meet the enrollment criteria for clinical trials geared towards regulatory approval through expanded access programs.[iii] These programs are meant to provide the drug directly to treat the patient’s condition, rather than having the primary goal of collecting efficacy or detailed safety data in support of approval. Before 1987, the FDA lacked formal recognition of expanded access, although investigational drugs were provided informally.[iv] Since then, the FDA has instituted novel classes of individual INDs so that a company sponsor or licensed physician can legally obtain treatment access from the FDA to provide a drug while it is still in the approval process.[v] Essentially, this provides companies a legal exception from the law to ship unapproved drugs across state lines, and if they desire, to charge for them. These INDs are designed solely for the potential benefit of desperate patients and not intended to formally collect safety or efficacy data that could potentially inform a regulatory decision, but can have regulatory impact, nonetheless.

At the outset, several participants objected to the term “compassionate use,” since it introduces inherent value decisions, can emotionally charge discussions, and does not recognize that there may be valid and ethically appropriate reasons for denial. The generally agreed upon term “expanded access,” is used throughout this paper. (One participant suggested the term “early access.”) Ideally, the term would make it obvious that this is access to an unapproved drug, in order to temper expectations of favorable results. Somewhat confusingly, the FDA uses the terms “expanded access,” “access,” and “treatment use” interchangeably to refer to the use of a drug, and of which none clearly identify the stage of development.[vi]

Participants shared numerous examples of requests for expanded access and explained that their companies handle anywhere from a handful to several hundred requests per year. The following selected stories illustrate the wide range of experiences and situations that companies encounter when navigating the complex decisions involved in administering an expanded access program. Several other examples were discussed and the specific participants expressed that they would be willing to share these particular examples publicly.

Chimerix, a 54-employee company based in Durham, North Carolina, is developing the drug brincidofovir and previously had created an intermediate expanded access protocol for the drug (CMX001-350) as encouraged by the FDA following over 200 emergency INDs granted for access to brincidofovir.[vii] One such case was for an armed services member with previously undiagnosed acute myelogenous leukemia who developed life-threatening vaccinia infection following smallpox vaccination in 2009.[viii] The patient received the drug from Chimerix through an emergency IND. After two years, the company had not secured FDA approval for the drug and eliminated expanded access in February 2012 in order to focus on studies which would inform a regulatory decision. In March 2014, Chimerix originally rejected an emergency IND request for 7-year old, Josh Hardy, who was critically ill from disseminated adenovirus infection after bone marrow transplantation. A highly public social media campaign targeted the company in the wake of this decision, and the experience was traumatizing for many of the employees. Following discussion with the FDA, Chimerix initiated a new clinical trial for the treatment of adenovirus infection in order to collect safety and efficacy data to support an NDA submission. Hardy was the first patient enrolled in the clinical trial, and his family reported through several media outlets that he recovered from the adenovirus infection and was discharged home.

One biopharmaceutical company representative described receiving a middle-of-the-night telephone call directly at home, with an emergent, time-sensitive request for an experimental therapy for a critically ill child with a rare acute disease in a foreign pediatric intensive care unit, where regulatory standards were different from those in the U.S. The ideal pediatric dosage was unknown, and only limited safety data and clinical details were available. Urgent efforts were made to gather more information and the request was approved, but despite these efforts the patient did not survive.

Bristol-Myers Squibb began a clinical trial for a cancer drug several years ago.[ix] A woman with pancreatic cancer enrolled in the trial and saw that her tumor was no longer growing. After the 3.5 year trial, the study closed because the drug was deemed ineffective for all other patients and was not approved for further development. However, the company continued to provide the drug for the one woman for whom the drug was effective through a single patient IND for an additional 9 years.

To demonstrate the volume of expanded access requests, one participant showed several messages on his mobile device during the half-day discussion, directly from patients who had located his email addresses through on-line searches, to plead for expanded access to an anticancer therapy.

Development of Structural Principles: The Four A's 

Broadly, no specific industry-wide consensus on expanded access procedures exists. As a result, there is significant variation in company policies and procedures. During this phase of discussion, participants shared their own company strategies and suggested possible areas of consensus that might form the basis for shared principles and industry-wide practices. These suggestions fell into four categories, which we termed the 4 “A’s”: Anticipation, Accessibility, Accountability, and Analysis (see Figure 1).

First, the group agreed that large and small companies should anticipate the need for and creation of expanded access programs when developing drugs expected to generate expanded access requests and as part of the drug development plan. This is particularly important for drugs that might be considered for priority or breakthrough designation during FDA approval. In these cases, companies should strongly consider developing a written expanded use policy with clear guidelines for inclusion and exclusion, which would also feature a defined review process, clear decision making criteria, and a defined time frame for response to requests. This also allows companies to plan for the demands that may be placed on their supply chain and staff resources to ensure sufficient supply for investigational and expanded use purposes. Identifying a decision maker within each company and for each disease area/product will also help patients or physicians reach the appropriate contact when requesting a drug, as well as assist the company in gaining expertise in responding to these requests. For example, one large company identifies one point of contact for all expanded access requests regarding each product and posts that individual’s contact information on the website.

In the early stages of drug development, supplies of investigational drugs are extremely limited. This is often because the technically-challenging process of optimizing drug product manufacture takes a considerable amount of time. Low yielding manufacture batches are not uncommon at the early phases of research. Some companies do not approve expanded access requests because they do not have enough of the drug in stock to supply these external requests and meet the needs of investigational study patients and individuals participating in clinical trials, an issue which may be particularly acute for biologics. Smaller companies may have more resource constraints, such as inadequate staff to manage requests or supply chain and logistics issues. One representative suggested that if a company had early transparency from regulators about the final numbers of subjects they would be willing to accept to achieve drug development milestones, it would make it much easier for the company to feel less reservation about its drug supply. (It may be beneficial for companies to analyze their financial ability to provide drugs potentially at no cost or when there is not a large enough supply, ideally in a transparent manner.)

Once an expanded access policy is anticipated and developed, the second key principle the group identified was making the policy accessible to all individuals who may qualify. First, for patients, with guidance from their treating physician, the company making the drug should always steer the patient to enter a clinical trial (if they meet eligibility criteria). If the contacted company cannot accommodate the patient, they should steer them to other open trials if possible, even if sponsored by another company. Many of our participants noted that this already occurs.

The group was particularly cognizant of the disparity in access to drug companies and their expanded access programs: patients with savvy social media strategies are more likely to succeed in navigating across organizational constraints than without similar sophistication. The group believes that increased accessibility would assist in making opportunities for expanded access more equitable. In addition, these policies could help educate patients and physicians about submitting legitimate expanded access requests and help decrease the costs of reviewing inappropriate requests on the company (for example, if there are other proven therapies or the situation is not life threatening).

If the patient is ineligible for a trial, the patient should be able to easily access the written expanded access policy online. For example, both large and small companies like Pfizer, Bristol-Myers Squibb, Shire, and Merck post their expanded access policies on their websites, though the terminology may in some cases be complex. In addition, Janssen has developed a video explaining their policies in non-technical terms. Ideally, such policies should be available in some web based or public facing platform to both patients and physicians and written in a clear manner that is jargon free and accessible to individuals at various education levels. Most participants felt strongly that requests for expanded access should originate from a medical provider, not from a patient, since expertise is needed to first screen appropriate candidates. This is consistent with current FDA regulations for an IND, in which a physician or qualified medical expert must sponsor an IND or serve as an investigator under an existing IND for expanded access.

Third, companies should have accountability to the requesting party for expanded use requests that they receive and review them within a specified, transparent amount of time. If the request could not be approved, the company should consider clear communication and provide an explanation of why the request was turned down. In these cases, some participants suggested that the company might also consider instituting an appeals process by which a patient can receive an additional review if not approved, potentially from a non-binding third party such as an independent, multidisciplinary body or a regulatory agency like the FDA. (Two participants, however, were uncomfortable with any third party review.)

The final principle would encourage companies to release timely analysis of data from expanded access patients. In addition to tracking communication, companies should keep a database of the number of requests and outcomes, in a manner that doesn’t slow getting drugs to needy patients rapidly. One company refined its internal tracking tools to determine who was requesting drugs, for what conditions, and where they lived. Where possible, companies might be encouraged to share anecdotal or preliminary safety or efficacy data from expanded access in peer-reviewed or other refereed venues in a prudent time frame following collections, if this is available or known. This is not always possible, because emergency INDs do not require provision of safety or outcome data to the company.

There are several challenges associated with operationalizing this in the current model, namely the appropriateness of anecdotal data, the level of detailed safety and efficacy data currently available through expanded access, suitability for publication, and funding for these activities in the current budget climate. One potential approach to address this is funding from federal or state regulatory agencies or payers for the reasonable costs of follow-up and reporting outcomes.

Regulatory Considerations

The participants then discussed the types of risks, including regulatory and financial, that may affect companies’ expanded access policies. When a company is considering expanded access requests, they consider the risks-benefits of providing the drug outside of a clinical trial as well as the potential for any regulatory issues in an era of litigation and an increased threshold for demonstration of safety. While a company’s provision of a drug for expanded access is voluntary, the FDA does require the company to collect and report safety data. Notably, none of the representatives felt that the FDA is a major regulatory barrier to processing and approving expanded access requests once the sponsor has reviewed the request, assessed the benefit-risk, and determined the request meets FDA requirements and evidentiary standards. In addition, the attendees felt that adverse effects and related liability risk were not of particular concern given that the drugs are assessed on a risk-benefit analysis.

However, companies that make drugs in particularly limited markets with small numbers of patients (for example, for unusual diseases with less than 200,000 patients nationwide which may justify a special designation called “orphan status”) may be more concerned about restrictive labeling if an unusual adverse event occurred even in one or two patients during expanded access of an orphan or small market therapy. However, there is no data of which participants were aware and no public reports that an adverse event during expanded access has harmed regulatory approval.[x] The group opinion was that that safety data would be available eventually in any event and an FDA “safe harbor” provision would not necessarily affect companies’ willingness to accept more requests for expanded access. A final concern was that there is no regulatory mechanism to consider data from expanded access in the evidence generation process for approval.

An Expanded Role for the FDA

While the FDA may not serve as a strong barrier to expanded access, the group considered strategies to promote equitable and fair access. For example, some argued that the breakthrough or priority review categories for FDA review might identify products that could have high potential for expanded access requests. This designation expedites “the development and review of drugs for serious or life-threatening conditions.”[xi] As of mid-April 2014, the FDA had received nearly 180 requests for breakthrough designation, with 44 requests granted.[xii] By hastening the drug development process, the FDA has already begun to bring drugs that have a reasonable expectation of benefit to the market faster. In order to receive breakthrough therapy designation, current legislation might be amended so companies could be asked to provide evidence that the 4 A’s are being followed in some capacity.

The FDA might also assist companies in establishing expanded access programs during open clinical trials in two main areas: process and capacity building. First, in terms of process, the FDA could be asked to create a defined path for regulatory approval with provisions that would encourage companies, both large and small, to include plans for expanded access programs when developing a drug. While FDA’s draft guidance related to INDs notes that larger expanded access programs could threaten enrollment in clinical trials,[xiii] and some participants agreed that this was a significant issue, not all companies have had difficulties enrolling patients in both clinical trials and expanded access programs. For example, one large pharmaceutical company left a Phase 1 clinical trial open for a promising therapy while concurrently enrolling individuals who didn’t qualify for open clinical trials into an expanded access program, without appreciable leakage of enrollees in their advanced phase trials that might affect the key development pathway.

Second, the FDA could support convening around capacity building and sharing best practices with companies. With the understanding that there are many small biotechnology or pharmaceutical companies with limited budgets and staff, the FDA could foster a partnership of large and small companies. This partnership could be achieved by convening meetings where companies share their experiences in creating and sustaining expanded access programs. This could be supported by creating a database for these shared ideas, as well as any expanded access data that can be made legally available, such as how many requests are granted or patient outcomes.

To ensure equitable, consistent, and transparent review of requests, some companies suggested the use of an impartial external advisory board. Similar to an unbiased review from an institutional review board (IRB), this committee could have an advisory or decision making function. Companies with supply constraints may feel that if they cannot give the drug to everyone who requests it, then they should give it to no one. This committee could help the company triage the patients who would benefit the most, and would be protected from liability.

Next Steps

The most efficient and equitable way to make new effective treatments to the largest number of needy patients is regulatory approval, accelerated or otherwise, following successful demonstration of efficacy and safety for a given indication in a specific population. Until that process is complete, access to an experimental therapy is by definition an additional risk, as the agreed necessary safety and efficacy have not yet been demonstrated. True informed consent in this setting is difficult to obtain (i.e. studies have shown that severely ill patients, such as those with life-threating circumstances requesting expanded access, had less retention of information discussed in the informed-consent process and less-clear understanding of the risks of therapy compared to healthier patients[xiv]).

One position companies and regulators can consider is that the default answer to expanded access requests should be affirmative, unless there are compelling reasons for not approving requests to patients with life-threatening illnesses. (Such reasons, for example, might include limited treatment supply or lack of reasonable expectation of benefits versus risks.) Such a position would require, however, that there be broader industry, clinician, regulatory, and patient advocacy agreement of shared principles. This paper outlines the experiences, structural principles, and regulatory considerations of a small group, but further meetings may convene a broader group of stakeholders to build upon these concepts. Such consensus-based approaches might lead to durable systems that meet the needs of desperate patients who have run out of options—while allowing innovation to continue to benefit those who may come afterwards.

Acknowledgements: We are grateful for the participation of the following representatives in the roundtable: Jeff Allen (Friends of Cancer Research), Michelle Berrey (Chimerix), Renzo Canetta (Bristol-Myers Squibb), Anne Cropp (Pfizer), Joseph Eid (Merck), Aaron Kesselheim (Harvard Medical School), Howard Mayer (Shire), Jeffrey Murray (FDA), Lilli Petruzzelli (Novartis), Amrit Ray (Janssen), and Robert Truog (Harvard Medical School). We thank Mark McClellan (Brookings Institution) for helpful discussions of this topic and comments on the manuscript, and to the Richard Merkin Foundation for support. The views and opinions expressed in this article were interpreted and organized by the staff of the Brookings Institution. They do not necessarily reflect the official policy or position of any individual roundtable representative, their companies, or their employers.

References

Downloads

• The Four A's of Expanded Patient Access

The Centers for Medicare and Medicaid Services (CMS) recently reported more optimistic news about the Medicare Accountable Care (ACO) Program, which began in 2012.  CMS released final first year financial and quality results for the Medicare Shared Savings Program (MSSP) ACOs and preliminary year two financial and quality results for the Pioneer ACO Model (Pioneer ACOs).

Financial Results: To date, the two programs have generated savings of $817 million—$372 million of which has been saved by Medicare and another $445 that has been returned to the ACOs through shared savings. While these savings are not final calculations, they suggest that both programs have produced modest savings in the first two years with some variability across ACOs.

Pioneer ACOs: Pioneers, generally considered more advanced ACOs, were able to generate more total program savings in year two than in year one ($96 million vs. $87 million), while also qualifying for shared savings payments of $68 million. The Medicare Trust Fund saved approximately $41 million in year two of the Pioneer program. In total, Pioneer ACOs were able to achieve an approximately 1% lower spending trend overall for the Medicare population than fee-for-service (1.4 vs. 0.45 percent lower per capita growth). Seventeen of the 23 Pioneer ACOs had positive or neutral financial performance, eleven of which were able to slow health spending enough to share in savings. On average, those ACOs saved $4.2 million in 2013, up from $2.7 million in 2012; shared savings grew from $1.2 million to $13 million. Six Pioneers generated losses, three of which were significant enough to require those Pioneer ACOs to share in the losses. While remaining Pioneers have been able to attain bigger savings in year two of the program, almost a third of original participants have left the program—some have moved to the lower risk MSSP, while others have focused on commercial ACO contracts or higher levels of risk in MA programs.

MSSP ACOs: MSSP ACOs were likewise able to reduce overall cost trend by slightly less than 1 percent. Of the 220 MSSP ACOs that started in 2012 or 2013, roughly one-quarter (53) were able to reduce spending enough to qualify for total shared savings of over $300 million. An additional 52 ACOs reduced spending compared to their benchmarks, but not enough to qualify for shared savings. One ACO that opted for track two (two-sided financial risk) overspent its benchmark by $10 million and owed shared savings of $4 million. MSSP ACOs as a whole were able to reduce spending by $652 million below their financial benchmarks and saved the Medicare Trust Fund $345 million, including repayment for the track 2 ACO losses.

Quality Results
Medicare ACOs continue to improve significantly on overall quality scores.  Both Pioneer ACOs and MSSPs have been able to attain higher average performance than quality benchmarks and better performance than Medicare fee-for-service on measures with data, such as colorectal screening, tobacco cessation, and depression screening.

Pioneer ACOs: All 23 Pioneer ACOs that remain in the program out of the initial 32 successfully reported their quality measures in their first two years.  The mean quality scores for Pioneer ACOs increased by 19 percent, from 71.8 percent in 2012 to 85.2% in 2013. Pioneer ACOs increased average improvement by 14.8 percent across all quality measures and overall improvement on 28 of 33 quality measures. Patients also report a positive experience receiving care from Pioneer ACOs—the ACOs improved average performance scores for patient and caregiver experience across 6 out of 7 measures.

MSSP ACOs: MSSP ACOs, as a group, posted even more improvement in quality scores than the Pioneer ACOs. MSSP ACOs starting in 2012 and 2013 were able to improve 30 of 33 quality measures, including measures such as patients’ rating of clinicians’ communication, beneficiaries rating of doctors, health promotion and education, screening for tobacco use and cessation, and screening for high blood pressure. In total, MSSP ACOs are experiencing higher CAHPS patient experience survey scores than Medicare fee-for-service, suggesting that patients are engaged and satisfied with being a part of an ACO. Additionally, MSSP ACOs achieved higher average performance rates on 17 of 22 Group Practice Reporting Option (GPRO) Web Interface measures reported by other large physician group fee-for-service providers.  Over 125,000 eligible providers or supplier members of ACOs qualified for incentive payments through PQRS (Physician Quality Reporting System) in 2013. Unfortunately, nine MSSP ACOs failed to successfully report their quality scores, four of which would have otherwise qualified for shared savings.

Digging Deeper into the Results
While program level analysis of financial performance is meaningful, a deeper analysis of the data and organizational characteristics of those MSSP ACOs that earned shared savings reveals some interesting trends. A little over half of those earning shared savings were physician-led ACOs (26/49) and more than a third of these physician led ACOs operate in Florida (10/26). The continued success of physician-led ACOs is consistent with previous findings that these ACOs may be better positioned than institutionally-based ACO to reduce overall costs. In addition, analysis by The Center for Medicare and Medicaid Innovation (CMMI) found that there is no relationship between savings/loss performances and whether the ACO included a hospital. Hospital-led ACOs were overall less likely to share in savings than physician-led ACOs. These two findings together suggest that ACOs can experience success even without an official hospital affiliation, paving the way for more physician practices to join and excel at accountable care.

Interesting regional trends are beginning to emerge from the data. Florida and Texas had the highest concentration of ACOs sharing in savings. Of the 30 Florida-based MSSP ACOs, more than a third (11) were able to share in savings, while almost half (7/15) Texas-based MSSP ACOs qualified for shared savings. Furthermore, the top two earning MSSP ACOs were from Texas (Memorial Herman with $28.34 million) and Florida (Palm Beach ACO with $19.34 million), respectively. The concentration of shared savings in these two states raises important questions about what is driving the high level performance. Are these MSSPs more likely to succeed because of a higher financial benchmark based on disproportionately greater regional Medicare spending? Do these ACOs have a leg up from the start because of their patient population and historical spending trend? Are physician ACOs more likely to form and succeed in these higher-cost areas? The success of these programs should not be understated, but further analysis may be needed to better understand performance drivers so appropriate program adjustments may be considered to level the playing field among MSSP ACOs across all regions.

Next Steps
While these latest Medicare ACO results are encouraging, more work needs to be done. The Pioneer Program recently lost its tenth program participant, Sharp Healthcare, bringing the total number of Pioneers down to 22. Like some other Pioneers that have exited the program, Sharp was dissatisfied with the benchmark and payment methodology and was no longer willing to assume financial risk that they felt was too great. This is just one among many policy and implementation issues with which Medicare ACOs are struggling. In June, we published a set of recommendations to ensure the long-term sustainability of the Medicare ACO program by addressing eight major ACO challenges. These results seem to reinforce the need for several of these recommendations for change in the Medicare ACO Program.

CMMI, which administers the Pioneer ACO Program, has recognized some of these challenges and has begun giving ACOs some greater flexibility in operating within the program. These changes include allowing them to move to population-based payments, waiving the 3-day hospitalization rule to allow ACOs to directly admit qualified patients to skilled nursing facilities, and experimenting with “voluntary alignment” to allow beneficiaries to attest to a primary care physician to offset some of the limitations of the existing attribution process. These are moves in the right direction; however CMS must continue to engage providers across the country to make sure the program remains viable.

Meanwhile, the MSSP will add another round of participants in January 2015 and CMS is expected to release a notice of proposed rulemaking that will amend the current operating requirements for the MSSP program later this year. The scope and nature of changes could dramatically impact the interest of new organization, as well as the continued participation of current MSSP and Pioneer ACOs.  Medicare ACOs will likely be encouraged to continue innovating to improve quality and reduce costs in the Medicare program, but the Medicare ACO program must continue to evolve to meet provider and beneficiary needs to ensure continued success.

Note: This blog has been corrected since its original posting on September 22 to reflect more accurate data.

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• Changes to Medicare ACO Program

The Centers for Medicare and Medicaid Services (CMS) recently released more detailed ACO-level data for participants in first two years of the Pioneer ACO Model. The program, which is designed for health systems with more experience assuming financial risk for patient populations, has generated savings and improvements in quality measures, but has also struggled to retain participants. The program began with 32 provider organizations; following a series of recent announcements there are now 19 total participants.

Last month, CMS announced that the Pioneer Program was able to yield total program savings of $96 million in its second year and resulted in ACOs sharing in savings of $68 million. CMS also reported that the Pioneers were able to improve mean quality scores by 19 percent and increased performance on 28 of 33 measures between performance year one and performance year two.

Financial Results

The latest financial results provide more participant-level data and allow for a new level of analysis of performance across all these ACOs. In year one of the program, financial performance for individual Pioneers ranged from a gross loss of $9.31 million to a gross savings of $23.34 million. Thirteen Pioneers reduced costs enough to qualify for shared savings, with an average of $5.85 million returned to the ACOs, ranging from $1.00 million to $14.00 million. One ACO owed shared losses of $2.55 million. The remaining eighteen ACOs were within the minimum savings or loss rate and did not earn shared savings or owe money to Medicare due to losses.

Following year one, nine Pioneer ACOs either left the Medicare ACO program entirely, or moved to the lower risk Medicare Shared Savings Program (MSSP). Eight of the nine Pioneers that left the program failed to reduce spending in their first year. Out of the remaining 23 participants in the second performance year, three of these ACOs opted to defer reconciliation until the end of Performance Year 3. The 20 Pioneers with final Performance Year 2 data had financial performance ranging from a gross savings of $24.59 million to gross losses of $6.26 million. Fourteen ACOs reduced spending in Performance Year 2, eleven of which reduced enough to qualify for shared savings. The average shared savings for these ACOs was $6.55 million, ranging from $1.22 million to $13.41 million. Three Pioneers shared losses, averaging $2.33 million back to the Medicare program.

The table below shows the breakdown of ACOs according to whether they reduced spending, increased spending, shared in savings, or owed money back to Medicare due to losses. More than half of the Pioneers were able to reduce spending in year one (18/32) and year two (14/23), with more than one-third of total ACOs earning shared savings in each year as well.

The data also suggest that those ACOs that were most successful in reducing spending in the first year were also more likely to reduce spending in their second year. As the chart below shows, three ACOs that earned shared savings in year one owed money back to Medicare due to losses in year two, while no ACO that had shared losses in year one was able to attain shared savings in year two.  

Quality Results

CMS also released ACO-level performance on all 33 measures for Pioneer participants in year one and year two. The 23 ACOs that remain in the Pioneer Program showed overall improvement in average quality scores from the first to second performance year. The ACOs also improved overall on 28 of 33 measures, as the chart below shows.

The quality domain with the greatest improvement in year two was Domain 4 (At Risk-Populations) which saw an overall improvement from 67.5% to 83%. The marked improvement in this domain suggests that ACOs are making progress at better coordinating and delivery care for high-risk patients, many of whom have multiple chronic conditions. Chronic care management for conditions such as diabetes, coronary artery disease, and hypertension is critical for the continued success of accountable care efforts. All other domains saw average quality improvement as well, summarized below.

Likewise, almost all of the individual Pioneer ACOs improved their performance on quality measures from year one to year two. Of the ACOs that remained in the program for year two, all but one ACO was able to improve its overall quality score in its second year.

Additionally, the percentage of Pioneer ACOs performing in the 80^th or 90^th percentile in quality scores also increased from year one to year two, as shown in the chart below.

Putting Together Financial and Quality Results

In year one of the Pioneer Program there appeared to be no direct correlation between average quality scores and gross savings or losses for individual ACOs. This may not be unexpected, especially since Pioneer ACOs in their first year are eligible for shared savings simply by reporting their quality. In subsequent years, however, the ACO’s quality score impacts the level of shared savings that the Pioneers are eligible to receive, so we might expect a bit more alignment between quality and financial performance. Average quality scores and level of savings or losses for each of the 32 first year Pioneer ACOs is below.

After year two, there still does not appear to be a direct relationship between higher quality scores and level of savings or losses in the Pioneer Program. Further examination of results begs additional questions about why certain ACOs clustered in different parts of the grid relative to others.

Of those ACOs in the red circle above— higher total savings and relatively average quality scores—two of the ACOs are from the Boston area and the remaining ones from other large metropolitan areas (New York City; Orange County, CA; Phoenix, AZ; and Detroit, MI). The average per capita Medicare spending for the counties corresponding to these ACOs is $11,544, compared to an average of $10,384 for counties corresponding to all 23 of the Pioneer participants.

Meanwhile those ACOs within the yellow circle had the highest quality scores, but also experience financial losses or slight savings. Many of these ACOs are from less densely populated areas, such as Maine, Wisconsin, and Illinois. There are a number of factors that could be contributing to their quality success, but little financial savings—healthier patient populations, a smaller or more engaged patient population, financial baselines impacted by lower per capita spending in these areas, or other factors driven by their region. Further analysis of these ACOs and the other public and private ACO programs, including both their characteristics and regional market characteristics, will provide needed further insights on the factors most likely to drive success.

Next Steps

These ACO-level data reflect the range of experiences across Pioneer participants. Some ACOs have sustained positive performance to date, while others have seen diminishing rates of return. Those organizations more committed to clinical transformation, patient outreach, and organizational change may be more likely to do better, but further analysis of differences in performance could enable the Pioneer Program and ACOs to achieve bigger impacts over time.

It is hard to know what the third performance year of the Pioneer program will show, but as noted earlier, the Pioneer Program has already lost over a third of its original 32 participants. Despite the decline in participation and mixed results so far, CMS remains optimistic and committed to the program, and the overall number of Medicare, Medicaid, and privately-insured individuals in ACO arrangements continues to rise. We can anticipate a proposed rule impacting the MSSP, likely later this Fall, which will impact elements of the Pioneer ACO program. Regulatory changes that may help increase the ability of the Medicare ACO programs to support better care while ensuring sustainability include: adjustments to attribution methods, benchmark calculations, collection and sharing of data with ACOs, updating performance measures, linking to other ongoing payment and delivery reforms, and creating more financial sustainability for program participants. The current Pioneer program can be a key step toward effective payment reform, but further steps are needed to assure long-term success.

Event Information

2015 is a crucial year for the international community. For the first time, all nations will converge upon a new set of Sustainable Development Goals applicable to advanced countries, emerging market economies, and developing countries, with the experience of implementing the Millennium Development Goals to build upon. Implementation is the critical component.

The Brookings Global Economy and Development program hosted a day-long private conference at the Brookings Institution in Washington, DC on Monday, March 30 to focus on “Governance innovations for implementing the post-2015 Sustainable Development Agenda.”

Hosted in collaboration with the Ministry of Foreign Affairs of Finland, this high-level conference drew on experiences from the North-South Helsinki Process on Globalization and Development carried out over the past 15 years. The Helsinki Process presaged many of the prerequisites for achieving accelerated progress by linking goal-setting to goal-implementation and by utilizing multistakeholder processes to mobilize society and financing for social and environmental goals to complement sound economic and financial policies. 

Download the conference agenda »
Download the related report »
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Brookings President Strobe Talbott shakes hands with Finland’s Minister of Foreign Affairs Erkki Tuomioja after welcoming participants to the conference.

Former President of Finland Tarja Halonen shares insights in the conference’s opening panel.

Over 75 conference participants from governments, multilateral institutions, civil society, the private sector, and think tanks participated in a number of roundtable discussions throughout the day.

President Halonen and Minister Tuomioja share lessons from the Helsinki process as conference participants consider paths forward for implementing the post-2015 Sustainable Development Goals.

Event Materials

• 330 PostReportFinal
• Conference Agenda_FINAL
• March 30 List of Registrants
• Conference Statement Brookings Post2015 Implementation

“The Earth in the coming decades could cease to be a ‘safe operating space’ for human beings,” concludes a paper by 18 researchers “trying to gauge the breaking points in the natural world,” published in Science in January 2015. That our planetary environment seems to be approaching “breaking points” is but one of several systemic threats looming on the horizon or lurking under the surface.

Since the economic crisis in 2008, the world has learned that financial instability is a global threat to sustainable livelihoods and economic progress. The underlying dynamics of technological change seem to be more labor displacing than labor absorbing, creating increasing anxiety that employment and career trajectories are permanently threatened. These two challenges undermine public confidence in the market economy, in institutions, and in political leaders. They constitute systemic threats to the credibility of markets and democracy to generate socially and politically sustainable outcomes for societies.

The fact that one billion people still live in extreme poverty, that there are scores of countries that are considered to be “failed states,” and that genocide, virulent violence, and terrorism are fed by this human condition of extreme deprivation together constitute a social systemic threat, global in scope. These challenges together merge with a growing public awareness of global inequality between nations and of increasing inequality within nations. The power of money in public life, whether in the form of overt corruption or covert influence, disenfranchises ordinary people and feeds anger and distrust of the current economic system. 

These challenges are global in reach, systemic in scale, and urgent. They require deliberate decisions to abandon “business-as-usual” approaches, to rethink current practices and engage in actions to transform the underlying fundamentals in order to avoid the collapse and catastrophe of systems that average people depend upon for normal life.  

Systemic risks are real. Generating new pathways to systemic sustainability are the new imperatives. Holistic approaches are essential, since the economic, social, environmental, and political elements of systemic risk are interrelated.  “Sustainable development,” once the label for environmentally sensitive development paths for developing countries, is now the new imperative for systemic sustainability for the global community as a whole.

2015 is a pivotal year for global transformation. Three major work streams among all nations are going forward this year under the auspices of the United Nations to develop goals, financing, and frameworks for the “post-2015 Sustainable Development Agenda.”  First, in New York in September—after two years of wide-ranging consultation—the U.N. General Assembly will endorse a new set of global development goals to be achieved by 2030, to build upon and replace the Millennium Development Goals (MDGs) that culminate this year. Second, to support this effort, a Financing for Development (FFD) conference took place in July in Addis Ababa, Ethiopia, to identify innovative ways to mobilize private and public resources for the massive investments necessary to achieve the new goals. And third, in Paris in December, the final negotiating session will complete work on a global climate change framework.  

These three landmark summits will, with luck, provide the broad strategic vision, the specific goals, and the financing for addressing the full range of systemic threats.  Most of all, these events, along with the G-20 summit of leaders of the major economies in November in Antalya, Turkey, will mobilize the relevant stakeholders and actors crucial for implementing the post-2015 agenda—governments, international organizations, business, finance, civil society, and parliaments—into a concerted effort to achieve transformational outcomes. Achieving systemic sustainability is a comprehensive, inclusive effort requiring all actors and all countries to be engaged. [3]

Four major elements need to be in place for this process to become a real instrument for achieving systemic sustainability across the board. 

First, because everyone everywhere faces systemic threats, the response needs to be universal. The post-2015 agenda must be seen as involving advanced industrial countries, emerging market economies, and developing nations. Systemic sustainability is not a development agenda limited to developing countries, nor just a project to eradicate poverty, nor just an agenda for development cooperation and foreign aid. It is a high policy agenda for all countries that goes to the core of economics, governance, and society, addressing fundamental dynamics in finance, energy, employment, equity, growth, governance, and institutions.

Second, systemic threats are generated because of spillover effects from activities that used to be considered self-contained and circumscribed in their impact. The world of silos and vertical self-sufficiency has given way to an integrated world in which horizontal linkages are as important as vertical specialization. The result of these interlinkages is that synergies can be realized by taking comprehensive integrated approaches to major issues. In this new context, positive-sum benefits are potentially more easily realized, but integrated strategies are necessary for doing so. 

This new context of spillovers and synergies has two implications. The domestic dimension is that whole-of-government approaches are necessary for addressing systemic sustainability. Cross-sectoral, inter-ministerial approaches are essential.  Since markets alone are not able to realize optimal outcomes in the widespread presence of externalities, the only way to realize the positive sum potential of synergies is through coordination among related actors. On the international dimension, this new context also requires more cooperation and coordination than competition to realize synergistic, positive-sum outcomes.

Third, domestic political pressures are primary. This may be a variant of the old saying that “all politics is local.”  However, the aftermath of the 2008 global financial crisis has been a world of hurt in which impacted publics are feeling anger and alienation from an economic system that has threatened their jobs, incomes, pensions, homes, and livelihoods. The task of leaders is not to pander to these plights but to lead their people to understand the vital linkage between domestic conditions and external forces and the degree to which the global context inevitably impacts on domestic conditions. Leaders need to be able to explain to their people that systemic threats have inextricable global–domestic linkages that need to be managed, not ignored.

Fourth, given all this, it is absolutely necessary that the global system of international institutions be “on the same page,” share the same vision, strategy, and goals, rather than each taking its primary mandate as a writ for independence from the common agenda. 

The major challenges for global governance in this pivotal turn from goal-setting in 2015 to the beginning of implementation in 2016 are to ensure (i) that all countries adapt and adopt the post-2015 agenda in ways that are congruent with their national culture and context while at the same time committing to reporting on all aspects of the agenda; (ii) that whole-of-government institutional mechanisms and processes are put in place domestically to realize the synergies that can accrue only from comprehensive, integrated approaches and that international cooperation mechanisms gain greater traction to reap the positive-sum outcomes from global consultation, coordination, and cooperation;  (iii) that national political leaders learn new modes of domestic and international leadership that are capable of articulating the new context and new systemic risks that need to be managed both internally and globally; and (iv) that each international institution realizes the need to be part of a system-wide global effort to achieve systemic sustainability through concerted efforts of all relevant actors working together on behalf of a common global agenda. [2]

Currently under discussion are 17 Sustainable Development Goals (SDGs) and 169 indicators for 2030 to extend and replace the eight MDGs for 2015, which had 21 targets and a variety of indicators, which in turn extended and replaced seven International Development Goals (IDGs) agreed to in 1995 by development cooperation ministers from OECD countries. There is much chatter now about whether the SDGs and indicators are too many, too ambitious, and too widespread.  The Economist asserts that the SDGs “would be worse than useless,” dubbing them “stupid development goals”. And Charles Kenney at the Center for Global Development in a thoughtful piece argues that “we lost the plot.” 

It may be true that there is too much detail. Two previous efforts, one by the Centre for International Governance Innovation (CIGI) and the Korean Development Institute (KDI) had 10 goals, and the other, the U.N. High Level Panel of Eminent Persons report in 2013 had 12 goals.[iii] This quibble alone does not prevent the use of political imagination to conjure a storyline that connects the 17 proposed SDGs with the vision of the post-2015 Sustainable Development Agenda as addressing systemic threats and having comprehensive integrated strategies for addressing them. 

Fourteen of the 17 SDGs can be clustered into four overarching strategic components: poverty (2); access (6); sustainability (5); and partnership (1). The other three goals have to do with growth and governance (institutions), which were underpinnings for both the IDGs and the MDGs though not embodied in the sets of goals themselves. The four SDG components seamlessly continue the storyline of the IDGs and the MDGs, both of which included poverty as the first goal, gender equality- education-and-health as issues of access, an environmental sustainability goal, and (in the MDGs) a partnership goal. The two underpinning components of growth and governance remain crucial and, if anything, are still more important today than 20 years ago when the global goal-setting process began. 

Continuity of strategic direction in transformational change is an asset, ensuring persistence and staying power until the goal is fulfilled.

The SDGs now convey a sense of the scale and scope of systemic threats. The sustainability goals (goals 11 through 15) highlight the environmental threats from urbanization, over-consumption/production, climate change, destruction of ocean life, to ecosystems, forests, deserts, land, and biodiversity. No knowledgeable person would leave out any of these issues when considering threats to environmental sustainability. 

The fact that goal 10, to “reduce inequality within and among countries,” is on the list of SDGs signals a new fact of political life that inequality is now front-and-center on the political agenda globally and nationally in many countries, advanced, emerging, and developing. This goal is really the “chapeaux” for goals 3 through 7, which deal with health, education, gender, water and sanitation, and energy for all—the access goals that must be met to “reduce inequality within and among countries.” It is inconceivable that a group of global goals for a sustainable future in the 21st century would leave out any of these goals crucial for achieving social sustainability, and undoubtedly political sustainability as well. 

Reducing inequality is not an end in itself but a means of providing skills and livelihoods for people in a knowledge-based global economy and hence the social and political sustainability required for stable growth. Growth is both a means and an end.

The two poverty goals are now more ambitious and inclusive than earlier. “Ending poverty” is different from reducing it, as in the IDGs and MDGs. And “ending hunger” through food security, nutrition, and sustainable agriculture are means to the end of eliminating poverty. For the Economist, eliminating extreme poverty should be the most important goal, stating that “it would have a much better chance of being achieved if it stood at the head of a very short list.”

This observation would apply if the SDGs are again intended to be, as the IDGs and MDGs were previously, development goals for developing countries. But development for developing countries is not the primary thrust and drive of the post-2015 agenda taken as a whole.  

The world is now facing systemic risks that threaten unacceptable collapse in social, political, economic, and environmental systems. A global community under threat from systemic risks needs a strategic vision and a pathway forward with specific guideposts, benchmarks, and means of implementation. 

The SDGs, the FFD documents and the U.N. Framework Convention on Climate Change accords will not be perfect. But, the three U.N. processes in 2015 capture the main elements, attempt to get specific in terms of priority actions and accountability, and together will provide a vision for the future for achieving systemic sustainability in its multiple, interconnected dimensions.

To think that simplifying the wording is going to simplify the problems is illusory. To narrow the vision to poor countries and poor people is to misunderstand the systemic nature of the threats and the scope and scale of them. 

This is a global agenda for all. Partnership now means we are all in the same boat, no longer acting on a global North-South axis of donor and recipient. Without the participation of all nations, all stakeholders, and all the international institutions, actual transformation will fall short of necessary transformation, and the world will reach breaking points that will inflict pain, suffering, and high costs on everyone in the future. The post-2015 Sustainable Development Agenda for 2030 brings an awareness of the future into the present and makes us understand that the time for action is now. 

Endnotes:

[1] For an example of a recent multistakeholder interactive conference on this set of issues, review the related report on the Brookings-Finland private meeting on March 30, 2015 on “implementing the post 2015 sustainable development agenda.

[2] See “Action Implications of Focusing Now on the Implementation of the post-2015 Agenda,” which outlines in more detail the key elements of implementation that need to be set in motion during 2015 and 2016, emphasizing especially roles for the Turkey G-20 summit in 2015 and the China G-20 summit in 2016.  

The consequences of the global financial crisis still ripple through the international system after the initial surge in global economic cooperation and governance immediately following the crisis. The ultimate effects have been that, while some elements of the international system of institutions have gotten stronger, the system as a whole is now seen as weaker, fractured, and driven more by geopolitical conflict than by institutional norms and frameworks.

The issue is how to move the global policy agenda forward in such a way that substantive progress induces institutional strengthening. The next two years offer new opportunities for creating a positive symbiosis between policy advance and systemic improvements.

I. The U.N. global agenda

The United Nations global agenda has three tracks that relate to each other and provide opportunities to pull the world together around an integrated, comprehensive strategic vision for the world’s people and strengthen the international system in the process.

The first track is the elaboration of a sustainable development agenda for each and all countries, not just developing countries, but advanced industrial economies and emerging market countries too. This effort is already well underway and will result in a summit of global leaders in September 2015 at the U.N. General Assembly (UNGA) in New York. This process entails a set of Sustainable Development Goals (SDGs) for 2030 to be developed and affirmed by and for all countries, and which succeed the Millennium Development Goals (MDGs) that culminate in 2015 and applied only to developing countries. This post-2015 goal-setting process will provide the substantive, cross-cutting, multidimensional agenda for the next 15 years. It is simultaneously a social, economic, and environmental agenda that relates goals to each other in functional terms requiring coordination among public and private sectors, ministries, civil society groups, and international institutions.

The second track is the financing for development (FFD) track, which goes well beyond reliance conceptually and practically on foreign aid or official development assistance as in the past. FFD for the SDGs includes a focus, first and foremost, on domestic sources of finance beyond government revenues. FFD is engaged in searches for innovative sources of finance, private sector mobilization of resources, creative market incentives and mechanisms, initiatives by civil society organizations, and development of entrepreneurial and small- and medium-size business opportunities that address global issues. This effort resulted in a global leaders meeting in Addis Ababa, Ethiopia in July of 2015 that reached agreement on the major thrusts for mobilizing resources for the post-2015 agenda (Kharas and MacArthur (2014)).

The third track is the global climate change negotiations currently under way to achieve a global agreement on the United Nations Framework Climate Change Convention (UNFCCC), which will result in a global summit in Paris in December of 2015. While these detailed negotiations on climate are a separate track, it is clear that the sustainable human development trajectories being put forward in the post-2015 agenda impact and are crucially affected by the efficacy of the climate change arrangements worked out in the UNFCCC agreements in 2015.

Whereas these three tracks operationally are going forward separately, the substantive aspects of each track affect and are affected by the content of the other two. The ultimate convergence of these three streams of activities and actions will have to occur in the beginning of 2016 at the global, regional, and national levels if the implementation phase is to be successful. A business-as-usual approach will not be satisfactory if at the global level, for example, the international institutions are unable to coordinate their work, or if at the national level ministries remain within their “silos” of sectoral expertise and responsibility.

Synergies exist between goal areas that cannot be realized without coordination across sectors and institutions, impacting goal achievement (see OECD 2014 PCD). A systemic approach is necessary at all levels to address the global challenges identified in the post-2015 agenda.

II. The G-20 summits for 2015 and 2016

A major opportunity presents itself in terms of providing impetus, momentum, and leadership for these large work streams and their convergence by linking the G-20 presidency of Turkey for 2015 with the G-20 leadership of China in 2016. Turkey and China working together in tandem within the G-20 Troika over the next two years to explain, support, and sustain the mobilization effort toward the post-2015 agenda could be a major contribution to it but also strengthen the global system of international institutions in the process. For the Turkish G-20 summit, scheduled to take place in November 2015 in Antalya, between UNGA in New York in September and the UNFCCC in Paris in December, Turkey could use part of its G-20 summit to have the leaders of the world’s largest advanced and emerging market economies explain to the world the nature, importance, and relevance of the SDGs to domestic concerns and priorities of ordinary people.

A weakness of G-20 summits thus far has been that G-20 leaders have become trapped by finance ministers’ issues and discourse and have failed to connect with their publics on larger issues of direct concern to people everywhere. The post-2015 agenda provides an opportunity for G-20 leaders to lead their people in understanding how global efforts relate to domestic conditions and why dealing only domestically with issues will not suffice to advance the human agenda where the global interface is extremely palpable. G-20 leaders, under Turkey’s leadership, could step out beyond the technical jargon of finance ministries and central banks, as important as those issues continue to be, and directly address the longer-term, fundamental conditions that affect the lives and livelihoods of all people. They would thereby strengthen their own leadership profile internally by explaining the global dimensions of domestic issues as means of creating public support for the sustainability issues in the post-2015 agenda.

Past experience with the International Development Goals (IDGs) of the 1990s and the Millennium Development Goals since the early 2000s  demonstrates that linking the goal-setting effort to the implementation phase yields powerful results by capturing the political momentum of the goal setting phase and carrying that energy forward directly into implementation efforts. If Turkey and China were to work together in 2015 and 2016, thereby bridging the goal-setting year in 2015 to the beginning of the implementation phase in 2016, they could provide the catalytic leadership and continuity that would maximize the staying power of the momentum from one phase to the next.

China, for its G-20 summit preparations in 2016, could focus on developing a road map, in concert with the other countries and international organizations and especially with the United Nations, that would explicitly keep alive the activities, groups, and initiatives manifested in the goal-setting phase into the next phase of implementation beginning in 2016. These combined efforts by Turkey and China could jump-start societies focusing on accelerating efforts to transform their societies by mobilizing policies and resources for highly related goal areas of direct benefit to their people.

The immediate effects of coordinated sequential efforts by Turkey and China in their respective G-20 years to advance the post-2015 agenda would be to strengthen the relationship between the G-20 and the United Nations on the agenda itself and to strengthen the G-20 summits by having leaders lead on issues of central concern to their people, strengthening the G-20 as a leadership forum in the process. For these results to occur, Turkey and China would need to begin to work together now to develop concordance in their individual efforts and initiate activities that would benefit greatly by beginning now and running through 2016 and beyond.

Accelerating implementation: Several initiatives could be undertaken now that would set up the dynamics for accelerated implementation in 2016 and beyond.

• National strategies for achieving the SDGs: Encourage countries to adapt and adopt the SDGs to their respective priorities and social, political, and cultural contexts through deliberate decision processes and wide societal engagement.
• The role of parliaments: Bring parliamentarians and parliaments into the goal-setting process so that they are aware of the legislative, regulatory, and budgetary implications of the post-2015 agenda.
• The role of domestic ministries: Bring finance ministers and other domestic ministries and agencies together with foreign ministers in the goal-setting year to set in motion mutually involved functional relationships and operational guidelines to enhance implementation across sectors.
• The G-20 as broker and mobilizer: The G-20 could act as a broker between the International Monetary Fund (IMF), World Bank, World Trade Organization (WTO), Organization for Economic Cooperation and Development (OECD), and regional development banks and the U.N. and its agencies to assure not just coordination but more intensive interactions that would be designed to accelerate the mobilization of resources and as well as policies and private sector activities that would enhance implementation.
• The policy role of the OECD: The strong, substantive role of the OECD in G-20 summits on issues high on the G-20 agenda—such as structural reform, tax base erosion, development, environment, energy, employment, and social issues—position the OECD to continue to provide important substantive inputs to the G-20 in 2015 and 2016. The OECD would enhance the relationship of its 34 members with G-20 emerging market economies by OECD involvement in both the G-20 and the U.N. post-2015 agenda.
• Financial stability and the SDGs: Encouraged by the G-20 summits, the IMF, the Financial Stability Board, and the OECD could work together to integrate the financial regulatory reform agenda into the post-2015 U.N. process by clarifying the linkages between financial stability, regulatory reform, and incentives for long-term private investment in infrastructure (crucial to all the SDGs) and in productive activities which generate greater employment and growth.
• Multi-stakeholder participation in implementation: G-20 summits can facilitate multi-stakeholder processes for engaging civil society, labor, private sector, religious, academic, and expert communities not only in the G-20 summits, as is the current practice, but also in the post-2015 agenda and its implementation, connecting societal leaders with the SDG agenda.

III. The overarching importance of a single global agenda

If these efforts to bring together a wide cross-section of domestic and international agencies, public and private sector leaders, stakeholders, and civil society actors are to translate into actions that are meaningful to the lives and livelihoods of people, a single set of goals is essential. The lesson learned from the IDG-MDG experience was that the tendency to differentiate roles by identifying different institutions with different sets of goals was real. The United Nations had inadvertently put forward the Millennium Declaration at the September 2000 U.N. General Assembly that had “millennium targets” which were similar but not identical to the International Development Goals (IDGs). The IDGs had been developed in the mid-1990s by OECD development ministers and subsequently were endorsed by the World Bank, the IMF, the U.N. and the OECD. In fact, in 2000, for the first time ever, the heads of those four institutions signed, and the institutions themselves published, a joint report, A Better World For All: Progress towards the International Development Goals.

Despite the appearance of unity and in part because there was a lack of concordance between the Millennium Declaration Targets (MDTs) and the IDGs, there was a moment in March 2001 when it looked like there might be a decisive divergence between the U.N. and the Bretton Woods institutions, with the U.N. taking the lead on the MDTs and the World Bank and IMF taking the lead on the Poverty Reduction Strategy Process (PRSPs), leaving the IDGs marginalized altogether. This potential division of labor was thwarted by a decision to reconcile the differences between the MDTs and the IDGs by forging the Millennium Development Goals (MDGs), which embodied the principal elements of both. The MDGs surfaced and were endorsed by the Monterrey Summit on Financing for Development in March of 2002, keeping the major global institutions on the same page with bilateral donors and the same path moving toward achieving the MDGs in 2015.

Most people who know about the MDGs think their origins began at the U.N. in the year 2000. It is an often overlooked fact that the MDGs only came forward in 2002 to bridge the potential divide between the Bretton Woods institutions and the United Nations. If that divide had occurred, it would have been disastrous from a goal setting-goal implementation point-of-view. This history is quite important to bring forward into public light now because it illustrates divisive dangers that currently lurk under the surface threatening unity if not squarely addressed.

From the perspective of prioritizing implementation, the truth is that multiple sets of goals blur the strategic vision, fail to communicate direction, weaken effective leadership, and encourage special pleading for differentiated interests instead focusing on the common, public interest. The U.N. has the lead role in global goal setting and has strengthened its own role in the global system in recent years. However, looking forward now to the SDG implementation phase, a danger might be that the Post-2015 agenda could be seen as the creature and captive of the United Nations, whereas it must be fully endorsed and internalized within the global system of international institutions as a whole. For that to happen, it would be necessary to move now, during the goal-setting year, to include all the relevant international and domestic actors that are crucial to the implementation phase of the post-2015 agenda.

The implications of including the post-2015 agenda in the G-20 summits in 2015 and 2016:

• It would make clear to relevant publics and actors that this set of global goals is universal, applicable to advanced countries, emerging market economies, and developing countries; it is not a “development agenda” but a “sustainability agenda,” which is broader, more strategic, and higher on the policy agenda of most countries.
• It would make clear the inextricable dynamics between domestic priorities and global goals; the SDGs are not foreign policy objectives or aid targets for development; they are domestic priorities affected by global impacts and generating global spillovers that need to be managed, not neglected.
• It would make the incorporation of finance ministers and domestic ministers with foreign ministers, along with international institutions, an imperative, rather than a utopian, ideal.
• It would make obvious the need to have a wide range of international institutions dealing with health, labor, education, women, climate, and the environment on the same page with the United Nations and the Bretton Woods institutions working together toward the SDGs.
• It would link the need for multi-stakeholder participation in goal setting to the goal implementation phase to mobilize support, policies, and resources but also to reveal and work on the interconnectedness of the goals themselves taken as a whole. 

Hence, the critical imperative is that there be a single narrative, a single set of goals, for all the domestic and global players to relate to, affirm, and implement. Otherwise, a fractured global order will produce lower-yield outcomes, and competition among priorities, sectors, and actors will result in poorer goal performance than would be possible with an integrated, concerted approach where all actors are working toward the same ends.

IV. Possible G-20 Actions by Turkey and China

Turkey has developed a process for the G-20 summit scheduled for November 14-15, 2015 in Antalya. Implementation, inclusion, and investment—the three “I’s”—are the overarching themes already established. The three “I’s” ties are tightly tied to the Australian G-20 outcomes—implementing action plans to achieve the incremental growth target of an additional 2 percentage points of GDP by 2018; including lower-income people in growth and lower-income countries in the global economy; and investing in infrastructure.

Each of these priorities is supportive of and compatible with the post-2015 agenda, even though they are not yet directly addressed to it. A decision by Turkey to include the post-2015 agenda in the 2015 G-20 would be easily achieved by cross-walking the SDGs over to and into the three “I’s” and vice versa. The central priority of the post-2015 agenda is, after all, “implementation.” The overarching meaning of the six elements of the post-2015 agenda (dignity, prosperity, justice, partnership, planet, and people (U.N. SG Synthesis Report December 2014)) is their impact on “inclusion.” And “investment” in infrastructure is crucial to all of the 17 SDGs.

The three pillars for Turkey’s 2015 agenda are: (i) strengthening the global recovery and lifting potential growth (the 2 percent target); (ii) enhancing resilience (financial regulatory reform]; and (iii) buttressing sustainability. Clearly, the third pillar on sustainability opens the door for the incorporation of the post-2015 agenda into the Turkey G-20, if Turkey wishes to do so. And the other two pillars fully support the sustainability agenda and are linked to it, or need to be.

For China, the post-2015 agenda presents a unique opportunity for the Chinese government to seize on a global agenda that has specific, strong, and visible links to the domestic concerns of the Chinese people. China could use the 2016 G-20 summit both to provide international leadership for global cooperation and to demonstrate the connection of global issues to domestic conditions through their impact and spillover effects. Because the post-2015 agenda is a universal agenda, by prioritizing it in its G-20 summit, China would be embracing the multiplicity of its own identity as a developing country but also as a dynamic emerging market economy that is destined to eventually play a global leadership role equivalent to advanced countries.

Furthermore, China seems intent on being a competitive nation in various spheres while at the same time being cooperative in others. The G-20 summit presidency for China in 2016 provides China with an opportunity to strengthen its role in international cooperation by being ambitious in the reach of its agenda for the G-20 in 2016, by its conduct as a member of the G-20 Troika for the next three years, and as the host government for the G-20 in 2016. By choosing to support Turkey in its consideration of incorporating the post-2015 agenda in the G-20 summit in 2015 and by China itself addressing the implementation issues in 2016, China would be reaping the demonstrably higher-yield gains generated by linking the SDG goal-setting phase in 2015 to the implementation phase in 2016.

Integrating the three tracks of SDG goal setting, financing for development, and progress on climate change actions is complementary but complex. While challenging, China has sufficiently high stakes in the outcomes of all three of these tracks to have a national interest in leading a global effort over the next three years to energize the convergence of agendas and institutional mandates necessary to generate bigger outcomes for people everywhere, including in China.

V. Results: Strengthening global governance and leadership

What follows from the analysis here is that the decision to include the post-2015 agenda in the Turkey and China G-20 summits would be a choice about the substance but also about the process of global economic governance, in which the G-20 has a leadership role. To do so in the way outlined here, would:

• Strengthen the global system of international institutions by bringing them together around a single comprehensive, integrated sustainability agenda;
• Create synergies between the United Nations and the other international institutions rather than identifying the post-2015 agenda with the U.N. alone and relying unnecessarily on the U.N. for its implementation;
• Connect G-20 leaders with a broader human and planetary agenda beyond economics and finance, which in turn would connect G-20 leaders with their publics as they visibly address the domestic concerns of their people in their global context; and
• Strengthen the role of the G-20 in global economic governance by putting the G-20 out in front as a broker among stakeholders, a catalytic coordinator of relevant domestic and international actors, and a leader on behalf of the concerns, lives, and livelihoods of people.

Selected References

Colin I. Bradford (2002), “Toward 2015: From Consensus Formation to Implementation of the Millennium Development Goals. Issues for the Future: The Implementation Phase”, Development Economics Department (DEC), The World Bank, December 2002.

Colin I. Bradford (2014), “The Changing World Economy and Global Economic Governance”, power point presentation at the Korean Delegation seminar “The OECD and Global Governance”, OECD, Paris, December 11, 2014.

Colin I. Bradford (2014), “Global Economic Governance and the Role of International Institutions”, Second High-level Policy Forum on Global Governance:  Scoping Papers, UNDP Beijing China, 22 October 2014.

Colin I. Bradford (2015), “Governance Innovations for Implementing the Post-2015 Sustainable Development Agenda: Conference Report”,  Brookings Institution, Washington, D.C., March 30, 2015.  http://www.brookings.edu/~/media/Events/2015/03/30-post-2015-sustainable-development-agenda/330-PostReportFinal.pdf?la=en   

Ye Yu, Xue Lei and Zha Xiaogang (2014), “The Role of Developing Countries in Global Economic Governance---with a Special Analysis on China’s Role”, Second High-level Policy Forum on Global Governance:  Scoping Papers, UNDP Beijing China, 22 October 2014. Authors are from the Shanghai Institutes of International Studies.

Homi Kharas and John McArthur (2014), “Nine Priority Commitments to be Made at the UN’s July 2015 Financing for Development Conference in Addis Ababa, Ethiopia,” October 2014. http://www.brookings.edu/research/papers/2015/02/united-nations-financing-for-development-kharas-mcarthur

OECD (2014), “Policy Coherence for Development and the Sustainable Development Goals”, Paris: OECD, 10 December 2014, prepared for the 8^th Meeting of the National Focal Points for Policy Coherence for Development (PCD) held at the OECD on 17-18 December 2014. 

2015 is a pivotal year for global development; this fall is a pivotal moment. Meetings this fall will determine the global vision for sustainable development for 2030.

Three papers being released today—“Action implications focusing now on implementation of the post-2015 agenda,” “Systemic sustainability as the strategic imperative for the post-2015 agenda,” and “Political decisions and institutional innovations required for systemic transformations envisioned in the post-2015 sustainable development agenda”—set out some foundational ideas and specific proposals for political decisions and institutional innovations, which focus now on the implementation of the new global vision for 2030. This blog summarizes the key points in the three papers listed below.

Fundamentals for guiding actions, reforms and decisions

1) Managing systemic risks needs to be the foundational idea for implementing the post-2015 agenda.

The key political idea latent but not yet fully visible in the post-2015 agenda is that it is not a developing country poverty agenda for global development in the traditional North-South axis but a universal agenda based on the perception of urgent challenges that constitute systemic threats.

The term “sustainable development” by itself as the headline for the P-2015 agenda creates the danger of inheriting terminology from the past to guide the future.

2) Goal-setting and implementation must be effectively linked.

The international community learned from the previous two sets of goal-setting experiences that linking implementation to goal-setting is critical to goal achievement.  G-20 leader engagement in the post-2015 agenda and linking the success of the G-20 presidencies of Turkey (2015), China (2016), and Germany (2017) would provide global leadership for continuity of global awareness and commitment.

3) Focus on the Sustainable Development Goals must be clear.

Criticism of the 17 Sustainable Development Goals (SDGs) as being too defuse and too detailed is ill-founded and reveals a lack of political imagination. It is a simple task to group the 17 goals into a few clusters that clearly communicate their focus on poverty, access, sustainability, partnership, growth, and institutions and their linkages to the social, economic, and environmental systemic threats that are the real and present dangers.

The Bretton Woods era is over. It was over before China initiated the creation of the Asian Infrastructure Investment Bank (AIIB) and the BRICS New Development Bank (NDB). Never has it been clearer than now that maintaining a single global system of international institutions is essential for geopolitical reasons. For the implementation of the post-2015 agenda, all the major international institutions need to commit to them.

In a joint paper with Zhang Haibing from the Shanghai Institutes of International Studies (SIIS), we make five specific governance proposals for decision-makers: 

The implementation of the post-2015 agenda requires that nations internalize the SDGs by debating, adapting and adopting them in terms of their own domestic cultural, institutional, and political circumstances. It will be important for the U.N. declarations in September to urge all countries to undertake domestic decision-making processes toward this end.

2) Presidential coordination committees should be established.

To adequately address systemic risks and to implement the P-2015 agenda requires comprehensive, integrated, cross-sectoral, whole-of-government approaches.  South Korea’s experience with presidential committees composed of ministers with diverse portfolios, private sector and civil society leaders provides an example of how governments could break the “silos” and meet the holistic nature of systemic threats.

3) There needs to be a single global system of international institutions.

China’s Premier Li Keqiang stated at the World Economic Forum in early 2015 that “the world order established after World War II must be maintained, not overturned.” Together with a speech Li gave at the OECD on July 1st after signing an expanded work program agreement with the OECD and becoming a member of the OECD Development Center, clearly signals of China’s intention to cooperate within the current institutional system. The West needs to reciprocate with clear signals of respect for the increasing roles and influence of China and other emerging market economies in global affairs.

4) We must move toward a single global monitoring system for development targets.

The monitoring and evaluation system that accompanies the post-2015 SDGs will be crucial to guiding the implementation of them. The U.N., the OECD, the World Bank, and the IMF have all participated in joint data gathering efforts under the International Development Goals  (IDGs) in the 1990s and the Millennium Development Goals (MDGs) in the 2000s. Each of these institutions has a crucial role to play now, but they need to be brought together under one umbrella to orchestrate their contributions to a comprehensive global data system.

By engaging in the post-2015 agenda, the G-20 leaders’ summits would be strengthened by involving G-20 leaders in the people-centered post-2015 agenda. Systemically important countries would be seen as leading on systemically important issues. The G-20 finance ministers can play an appropriate role by serving as the coordinating mechanism for the global system of international institutions for the post-2015 agenda. A G-20 Global Sustainable Development Council, composed of the heads of the presidential committees for sustainable development from G20 countries, could become an effective focal point for assessing systemic sustainability.

These governance innovations could re-energize the G-20 and provide the international community with the leadership, the coordination, and the monitoring capabilities that it needs to implement the post-2015 agenda.

In the months leading up to the 2015 United Nations climate change conference in Paris starting November 30, global businesses have pledged to do their part for proactive climate action. To "capture and catalyze" these commitments, the UN Framework Convention on Climate Change, in conjunction with the government of Peru, launched the Non-State Actor Zone for Climate Change (NAZCA). NAZCA is an online portal that showcases commitment to action by companies, investors, cities and subnational regions to address climate change. To date, more than 2,000 companies—from Baosteel Group Corporation to Exxon Mobil Corporation to Taiwan Semiconductor Manufacturing to Wal-Mart Stores, Inc.—have made voluntary commitments to reduce emissions, increase energy use efficiencies and invest in renewable energy sources.

IT sector stands out 

Proactive action by businesses to combat global climate change is not new. Over the past decade, businesses have increasingly engaged in voluntary climate action to share best practices, network, promote market mechanisms, and set greenhouse gas emission reduction targets. Despite this, not all businesses are eager participants. My recent paper on the role of the Global 500 companies in transnational climate governance shows that, after controlling for political economic and institutional factors at the country level, global businesses operating in the information technology (IT) sector are twice as likely as other firms to engage in proactive climate action. Next to the consumer staples sector, the IT sector has the highest share of global companies engaging in proactive climate action compared to the energy, health care, industrials, materials and utilities sectors.

Among the notable IT companies worldwide that have taken proactive climate action, including public disclosures of their carbon emissions, are Apple Inc., Google Inc., Hitachi, Ltd., LG Innotek, Microsoft Corp., Ericsson and Telefonica.

There are several reasons why IT companies are in a better position than other corporations to play a proactive role in climate change mitigation. First, IT companies, as a sector, tend to be wealthier, not only in terms of asset holdings but also profitability. They also employ a larger number of workers than other companies. Large and well-endowed corporations are better able to afford the costly investments necessary for deploying renewable energy and for undertaking carbon emissions management. According to my findings, wealthy corporations that employ a large number of workers have two to four time higher odds of proactive climate action than companies with smaller asset holdings and employee base.

Complementary capabilities

Second, my research also shows that, more often than not, when a company demonstrates a commitment to sustainability through complementary capabilities and competencies, namely investments in environmental R&D and/or certification with the ISO 14001 environmental management standard, the odds are higher that the company also engages in voluntary climate action and carbon disclosure. For example, a larger share of companies in the IT sector (75 percent) are certified with the ISO 14001 environmental management standard than Global 500 companies excluding IT (54 percent). A similar pattern, albeit less pronounced, is also true of investments in environmental R&D by IT companies compared to other global companies (56 percent versus 48 percent).

Wealth endowment and complementary capabilities aside, IT companies are more likely than other Global 500 companies to have an in-house managerial- or executive-level sustainability officer. Close to half of all IT companies have formally created a position of a vice president of sustainability or a chief sustainability officer compared to about 40 percent of other global businesses. These in-house champions of sustainability policies and initiatives play a critical role in helping to align corporate vision and allocate the necessary resources toward sustainability efforts.

Among the world’s largest companies by revenue, Apple Inc. (rank 15^th) is a leader in proactive climate action: Apple has pledged to "maintain 100% renewable energy in datacenters… [and] maintain carbon neutrality of purchased electricity for U.S. corporate facilities achieved in 2014 through renewable energy purchases and onsite generation and procurement." In 2014, Apple hired Lisa Jackson, a former administrator of the U.S. Environmental Protection Agency as its vice president of environmental, policy, and social initiatives, reporting directly to CEO Tim Cook. Along with Jacky Haynes, Apple’s senior director of social and environmental responsibility who specializes in supplier responsibility, Jackson has brokered a relationship with the Beijing-based Institute of Public & Environmental Affairs to train Apple facilities workers as part of Apple’s new Environmental, Health, and Safety Academy and to proactively publish emissions data of Apple’s supplier facilities in China. By committing to voluntary climate action, Apple and other corporations signal to consumers that they are socially responsible companies, not only to preempt public scrutiny but to gain an advantage in the "market for virtues."

Apple and Microsoft Corp. are the only two private sector entities that earned the U.S. Environmental Protection Agency (EPA)’s Green Power Partner of the Year award in 2015, which recognizes leadership in green power use and overall strategy and impact on the green power market.

Other IT companies, such as Autodesk, BT, Infosys, Salesforce and SAP have recently joined forces with Aviva, IKEA, Starbucks, Walmart, Marks and Spencer, Johnson & Johnson, among others, as part of RE100, a collaborative initiative of businesses, to set long-term target on powering their operations entirely with renewable energy.

Living up to promises

The fact that so many companies are recognizing the dangers of climate change and setting ambitious climate action goals is laudable. The biggest challenge will be seeing that they live up to their promises, especially given the voluntary nature of initiatives such as NAZCA. To thwart greenwashing, national governments and global governance organizations have an important role to play to keep the IT sector and other businesses accountable. The first step that NAZCA has taken is to invite "partnerships with others who would…make assessments of this type." A significant next step would be to publish guidelines and best practices for third-party monitoring and verification in order to strengthen the link between pledges for proactive action and ultimate follow-through by corporations. IT companies, as leaders in proactive climate action, should be at the forefront of working to establish best practices for adherence to voluntary commitments for mitigating global climate change.

Capitalism has provided unprecedented wealth and prosperity around the world, but a growing community is raising concerns about whether the promise of the capitalist system to achieve a more shared and durable prosperity can be achieved without systemic changes in the way for-profit corporations are governed and managed. The change in public opinion has become evident among workers, consumers, and investors, as well as through new policies enacted by elected officials of both parties: more than ever before, the public supports businesses that demonstrate positive social change and sustainable development. These new attitudes have begun to take root in corporations themselves, with a growing community of investors, business leaders, and entrepreneurs expressing a fiduciary duty to create value not only for shareholders but for society. However, businesses and investors seeking to harness these opportunities face significant institutional and normative barriers to achieving their goals.

In a new paper, the co-founders of non-profit B Lab, Andrew Kassoy, Bart Houlahan, and Jay Coen Gilbert, write about this overarching culture shift, the importance of and impediments to effective impact governance and impact management to make this shift meaningful and lasting, and how a rapidly growing community of responsible businesses has overcome these barriers, is maximizing its social impact, and is creating pathways for others to follow. The impact and growth of the B Corp movement will be maximized not only through increased adoption by business leaders, but also through the unique roles played by research institutions, the media, policy-makers, investors, and the general public. With enough support, this movement may soon transform shareholder capitalism into stakeholder capitalism, in which businesses can more easily live up to their potential to create a more shared and durable prosperity for all. 

This paper is published as part of the Center for Effective Public Management’s Initiative on 21st Century Capitalism. It is one of more than a dozen papers written by academics and practitioners about the changing role of the corporation and the importance of improving corporate governance. The authors of this paper are the co-founders of B Lab, a nonprofit organization that oversees the certification of B Corporations, and a major subject of this paper. The perspectives put forth in this paper are solely those of the authors, based on their professional expertise in this area.

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Millions of Egyptians took to the streets in January 2011 chanting “‘ish, hurriyya, ‘adalah ijtima‘iyya,” or bread, freedom, and social justice. This simple chant captured protestors’ desire for a new Egypt defined by economic, political, and social change. Five years later, however, the attainment of those demands seems more elusive than ever. In the economic sphere, Egypt still faces the major challenge of high unemployment, particularly among educated youth. Why do so many of Egypt’s young university graduates struggle to find employment?

Read "Educated but unemployed: The challenge facing Egypt’s youth"

In this policy briefing, Adel Abdel Ghafar analyzes the roots of Egypt’s youth unemployment crisis, starting with the structural issues plaguing the country’s educational system. He then examines other contributing factors including neoliberal economic reforms, gender inequality, and the lack of entrepreneurship. Abdel Ghafar warns that failing to address the unemployment issue will increase the likelihood of another uprising.

Abdel Ghafar thus argues that the Egyptian government must urgently undertake reforms and devote extensive resources to dealing with youth unemployment. Specifically, he recommends ways in which Egypt can revamp public university funding, promote vocational training, stimulate entrepreneurship, and increase the participation of women in the workforce.

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Editor's Note: this article originally appeared in the 2012 Print Version of AARP: The Journal.

Using one platform to offer a variety of services

Known in the UK under the term “corporate platform” to indicate that it expands options available on the employer’s benefit platform, the development allows employees to use the employer’s retirement savings mechanism to save and invest for additional nonretirement purposes. When the corporate platform is fully implemented, employees will be able to man­age almost all of their investments and savings plans from one location, thus giving them a con­solidated view of their entire financial status. If carried to its full potential, the expanded saving platform will allow employees to shop for sav­ings products, among options that are available on the platform, instead of having to seek them out from individual suppliers—a search that often takes up work hours. Of even greater value, it gives employees one source to go to for indi­vidualized advice or financial literacy training.

The enhancement has special significance in the UK, where by fall 2012, the larger employers that don’t offer any other type of pension or retirement savings plan, must begin to automatically enroll their employees into basic retirement savings accounts. This requirement is causing a great deal of discussion about the future role of employer-provided benefits, as well as recon­sideration of the fees and services included in a traditional package. The platform enhancements allow an employer to differentiate its employee benefit package from the required basic account structure. It also gives younger employees a benefit of more immediate value, than they would have from a retirement savings account that they won’t access for a good 40 years.

Presentations from a variety of service providers at an October 2011 summit hosted by Pensions Insight, a UK trade journal, showed that the platform can be easily customized to meet the special needs of a specific workforce. Using a single computer interface, employees can select from a wide variety of savings and investment options that are appropriate for their income level and stage of life. Thus, an upper income manager who manages his or her own finances could see more sophisticated products, while an entry-level worker sees more basic sav­ings products. Live presentations by financial professionals who explain what is available on the computer platform add to the system’s value and increase its use.

A place to provide choice and to build financial literacy

The platform will have special value for moderate- and lower-income employees. While higher salaried employees may appreciate the opportunity to build their investments, the real value of the platform will be to enable moder­ate- and lower-income workers to find savings opportunities that they might otherwise miss because they don’t know where to go, are uncertain about what is a fair price, or for a variety of other reasons. Because employees tend to believe that services included on the corporate platform are implicitly endorsed by the employer, they usually have greater faith that the services are from legitimate providers at a fair price.

Employees at all levels can also use the site to receive guidance on individual products or basic financial literacy training. Individuals can choose from a range of options, from short videos on a specific topic by experts or fellow employees, to longer connected courses designed to meet the needs of specific age or income groups. Use is increased when employ­ees receive emails or text messages geared to birthdays or other life events, or generated after the employee visits a specific part of the website.

Understanding the value of peer evaluations to motivate others, some providers include a place where employees can post feedback about spe­cific products or savings choices. These postings help to guide other employees’ decisions and build the reputation of the platform as a source of unbiased information. The site can also include links to outside advisors who can answer specific questions, guide employees to another site for more information, or perform other services either online or over the telephone.

Differing age groups can be contacted and guided through different technologies. At the UK platform summit, David Harris, of Tor Financial Consulting, showed that younger employees preferred different communication methods than either older workers or the usual way employers provide information. However, the platform is able to use a wide variety of methods and is equally effective no matter which is used.

The platform’s value to international policy makers

Although the UK’s platform is intended as an enhancement to employer-provided benefits, it can also be used for a wide variety of policy goals, as the basic structure can be easily adapted to meet almost any nation’s specific tax and savings system. In the United States alone, policy experts have proposed dedicated savings accounts for nonretirement purposes ranging from unemployment benefits and retraining, home purchases, health care, and long-term health care coverage, to repaying student loans or building college balances for children or grandchildren. However, if all of these various accounts were established and funded, it is doubtful the employee would have any money left for food, clothing, and shelter.

Rather than having a host of specific savings programs, employees may be better served by more flexible accounts usable for a variety of purposes, as outside developments or chang­ing needs dictate. The platform concept would allow individuals to choose which purposes they need to save for and how much to save for each. Combined with targeted guidance or education, this structure could expose individuals to pos­sibilities they might not have considered before.

The structure is ideally suited to employment situations, but it could also be used by the self-employed or by consultants at sites aimed specifically at them and sponsored by trade associations, unions, or even government agen­cies. While their circumstances may preclude payroll deductions, the same products could be offered through direct debits to bank accounts.

The added value of nudge

The flexibility of the platform allows it to be used by employees with all levels of financial sophistication, but new participants would benefit from a variation on automatic enroll­ment that places certain amounts, in addition to the retirement savings amount, into a general savings account or similar vehicle. The automatic savings amounts deducted need not be large, and where the law allows, could vary according to employee age, with a larger proportion of the overall deduction going to nonretirement purpose for younger employees and to retirement for older ones.

As with automatic retirement enrollment, the employee would have the ability to vary amounts, divide the total among various accounts, and even stop all future contributions. However, automatic enrollment would offer workers direct experience with the nonretire­ment side of the platform. By varying enrollment in various accounts according to employees’ age, automatic enrollment could encourage them to consider saving for various purposes, such as a first home, college tuition for children, or additional health services.

Improving retirement security

Although the platform is applicable to a wide variety of other uses, its primary purpose is to build retirement security. Before retirement, the platform helps employees understand how to save, what they have, and how much more they need for a comfortable lifestyle. The other savings provide funds that can be used in the event of an emergency, thus helping to reduce leakage from retirement accounts in countries that allow early access to that money. At retire­ment, the platform helps individuals to see what other assets are available, and what loans or other liabilities must be factored in. In the UK, it is also being used to encourage individuals to use annuities and add them to their invest­ments. The UK experience can help to guide US policymakers in their efforts to increase the use of similar products.

The enhanced information and flexibility of the corporate platform should help individuals to better understand their finances and how to meet their goals. It moves retirement savings plans from a minor part of employees’ financial lives, to a central feature that has many more uses than just an event many years in the future. This promotes regular use of the platform, and a fuller understanding of what is necessary for a comfortable retirement.

Increasingly, many Marylanders are unprepared for retirement.

The US has the broadest range of retirement savings options in the world. There are thousands of retirement products offered. But most Marylanders don’t use them.

The need is growing. The Baby Boomers are the largest generation in history. They will live longer in retirement than any generation in history.

But – financially – many are not prepared. Many have virtually no retirement savings: more than a third those within ten years of retirement age have saved less than $10,000. $10,000 invested and spent over the average person’s retirement works out to about $1,000 of income per year. Even with Social Security, that’s not much to live on.

Fears about retirement are the #1 economic concern. Many Marylanders know they’re unprepared – and they’re worried about it. Concerns about retirement security are now more broadly based than the cost of health care, fear of job loss or other economic concerns – and have been for over a decade.3 Those concerns have grown since the financial crisis, even though the stock market has recovered. Many know they’ll have to defer retirement—and many fear they will never be able to afford to retire at all.

The key to retirement saving is having a retirement plan and contributing to it every paycheck. But many businesses, including most smaller businesses, don’t offer retirement plans. As a result 1,000,000 Marylanders working in private businesses across the State don’t have a retirement plan. There are, of course, individual retirement accounts (IRAs) -- but almost no one uses them who didn’t get access through an employer-based plan via payroll deduction.

Having a plan is essential, but not a panacea. Even when plans are available, many employees don’t join. Many who do contribute and save less than they need to meet their own goals. Even with plans, many will need to save more.

The challenge continues at retirement, because most of these plans are paid out in a single lump sum payment—few plans offer reliable retirement income for life that traditional pensions do. Since most retirees do not consult financial advisors and are not financial experts themselves, some who live longer than average or are unlucky in their investments will find that they haven’t saved enough and will exhaust their savings.

They will, of course, have Social Security. That’s why it’s so important that Social Security be both preserved and strengthened. But the average monthly benefit in Maryland is about $1,300 and for most people Social Security covers only a fraction of their basic needs in retirement. Most Marylanders will need additional income from retirement savings – and the State of Maryland can help them get it.

Other states and other governments are making it easier for people to save and for private employers to help them do it. Maryland should, too. Acting now will save Maryland taxpayers millions in the future.

California, Massachusetts, and Illinois have already enacted legislation. Illinois created a new program that requires employers who have no retirement plan to automatically enroll their employees in a state-created program. Massachusetts authorized a program for uncovered employees of non-profits. California created a board to plan and propose program similar to that in Illinois. Similar legislation is being or has been introduced in some fifteen other states – states all across the country with varying political orientations, populations, and economic bases.

Although there are many variations under consideration, these programs generally provide for an automatic payroll deduction of a set amount unless the employee opts out. Funds are to be invested professionally and may be pooled to achieve higher returns and lower costs. Those who cannot or do not want to make complex financial decisions are not required to do so – their contributions are placed automatically into a reliable fund or set of funds.

In order to ensure that employers – many of whom are small businesses – can participate in a program, it must be designed to help them avoid significant disruption, expense or administrative burden. This can be accomplished by enabling employers to use current payroll processes to help their employees to build retirement security, without requiring employers to make contributions themselves.

If Maryland doesn’t act now, Maryland taxpayers will face higher costs for decades to come.

These plans are designed to be self-sustaining: their operating costs are paid for by plan contributions and the State would not assume any obligations. In practice, however, these plans will end up saving taxpayer funds: If Maryland doesn’t act now, Maryland taxpayers will face higher costs for decades to come, as retirees are forced to turn to State assistance instead of living on their own savings.

There are many ways to improve retirement security. The key is for businesses to help their employees save, without becoming overburdened themselves.

Task Force is not recommending any one approach, but strongly recommends that Maryland join other states, by developing and implementing a plan that helps Marylanders have more secure retirements.We recommend development of a specific state-based program that meets Maryland’s needs from the options discussed in our report.

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In recent weeks, the Obama Administration has taken the two most important steps in nearly a decade to increase access to retirement savings for more than 55 million Americans who currently do not participate in a retirement saving plan.

The Treasury Department's myRA program, launched this month, will help new savers and the self-employed start accounts without risk or fees. And earlier this week, the Department of Labor clarified rules that will make it easier for states to create retirement savings plans for small business employees.

myRA

The new myRAs provide another way for new savers to build small nest eggs. They will also help consultants, contract employees, and part-time workers save for retirement or for emergencies. 

For employees, myRAs are payroll deduction savings accounts designed to meet the needs of new savers and lower income workers.  They have no fees, cost nothing to open, and allow savers to regularly contribute any amount.  Savings are invested in US Treasury bonds, so savers can’t lose principal, an important feature for low-income workers who might otherwise abandon plans if they face early losses.  Those who are not formal employees and thus lack access to an employer-sponsored plan can participate in myRA through direct withdrawals from a checking or other bank account. 

As the growing “gig economy” creates more independent workers, the myRA will be a valuable entry to the private retirement system.  These workers might otherwise retire on little more than Social Security. All workers can build myRA balances by redirecting income tax refunds into their accounts. Because a myRA is a Roth IRA (that is, contributions are made from after-tax income), savers can withdraw their own contributions at any time without penalties or tax liability.  

When a myRA reaches $15,000, it must be rolled into another account, and Treasury may make it possible for workers to transfer these savings into funds managed by one of several pre-approved private providers.  MyRAs won’t replace either state-sponsored plans or employer-related pension or retirement savings plans.  However, they will make it possible for new and lower-income savers as well as the self-employed to build financial security without risk or fees.  

State-Sponsored Retirement Savings Plans

The DOL announcement gave the green light to several state models, including Automatic IRAs, marketplace models, and Multiple Employer Plans.  About two dozen states are considering these plans and, so far, Illinois and Oregon have passed “Secure Choice” plans based on the Automatic IRA, while Washington State has passed a marketplace plan.

DOL’s proposed Automatic IRA rules (open for a 60 day comment period) would let states administer automatic enrollment payroll deduction IRAs provided that the plans meet certain conditions for selecting or managing the investments and consumer protections.  States would also have to require businesses to offer such a plan if they don’t already offer their employees a pension or other retirement savings plan. Companies that are not required to offer an Automatic IRA or other plan, but decide to join the state plan voluntarily could still be subject to ERISA. The Retirement Security Project at the Brookings Institution first designed the Automatic IRA, which was proposed by the Administration before being adopted by some states.

In a separate interpretation, DOL allowed states to offer marketplace plans without being subject to the Employee Retirement Income Security Act (ERISA).  These plans are essentially websites where small businesses may select pre-screened plans that meet certain fee or other criteria.  Under the DOL guidance, these marketplaces may include ERISA plans, but states cannot require employers to offer them.   However, if states sponsor a marketplace model, they could also require employers without other plans to offer Automatic IRAs.

Finally, DOL’s rules let states administer Multiple Employer Plans (MEPs), where individual employers all use the same ERISA-covered model plan.  MEPs are usually simplified 401(k)-type plans. Because the state would be acting on behalf of participating employers, it could assume some functions that would otherwise be the responsibility of the employer. These include handling ERISA compliance, selecting investments, and managing the plan.

The Retirement Security Project has issued a paper and held an event discussing ways states could create small business retirement savings plans. The paper is available here and the event is available here.

Together, the two initiatives—the new MyRA and the state-sponsored plans-- could greatly increase the number of American workers who’ll be able to supplement their Social Security benefits with personal savings.

When a new drug is approved in the United States, it is virtually impossible to know all of the risks that a population may encounter when using that product. Even though the U.S. Food and Drug Administration (FDA) requires drug manufacturers to meet rigorous standards demonstrating the drug’s safety and effectiveness for its intended use, once approved, drugs can be used by many more patients than were studied in clinical trials. This may include patients with unique clinical conditions, differing health status, ethnicity, age, or other characteristics which were not well-represented before the drug’s approval. Further, the drugs themselves can be used in different ways and in different settings than were studied. Until recently, FDA did not have the necessary tools and data access to rapidly and consistently track the risks of serious side effects of regulated drugs after approval. Recognizing this challenge, FDA has developed a pilot system to make the best use of available electronic health data using a new data and research network capable of evaluating the safety of medical products in the U.S. 

Authorized by the Food and Drug Administration Amendments Act (FDAAA) of 2007, this pilot is known as Mini-Sentinel, and is part of FDA’s larger Sentinel Initiative. Sentinel was envisioned as a national electronic system to track the safety of regulated medical products, through the use of existing health insurance claims and electronic clinical data that are generated as part of routine care. In the four years since its inception, Mini-Sentinel has made tremendous progress toward developing this system. Mini-Sentinel is comprised of insurance claims and clinical data from 18 participating data-partners, including some of the largest private health plans in the United States. In order to best protect patient privacy, the data from each partner is maintained behind each individual health plan fire-wall. This “distributed data” approach allows a single coordinating center to distribute FDA safety questions in the form of “queries,” to each of the participating data partners to be run against their own data. Aggregated summary results are then sent back to the coordinating center for final analysis. This process allows FDA to access data that can help in addressing safety questions in near real-time.  

Through Mini-Sentinel, FDA has the capability to better understand the safety outcomes using electronic health care data of approximately 169 million covered lives. This accumulation of data represents the capture of 382 million person-years of observation time and billions of prescription dispensings.[1] Examples of the types of safety questions that have already been addressed by Mini-Sentinel include the following:

• Safety concerns with drugs used to treat high blood pressure and the incidence of angioedema;
• Safety concerns with a new diabetes treatment and the incidence of heart attacks; and
• Impact of FDA regulatory actions (i.e. drug label changes) intended to mitigate serious risks of drugs.

The Mini-Sentinel pilot has demonstrated substantial progress and has proven to be a very useful tool for FDA, largely due to the strong partnerships developed between FDA, collaborating academic institutions, and private health plans. However, in order to ensure continued progress and long-term sustainability, it will be critical for progress to continue in several key areas. 

First, continued methods development and data understanding will be necessary to ensure FDA has access to the most innovative tools. The field of pharmacoepidemiology and drug safety surveillance is still young and the continued development of better study designs and analytic tools to quantify risks of serious adverse events, while accounting for many confounding factors that are inherent on observational data, will be critical. Further, as health reforms impact that way health care is delivered and financed (e.g., development of accountable care organizations and increased use of bundled payments), the electronic health data will change. It will be important to focus efforts on understanding how these changes will impact data used for safety evaluations. 

Second, it is clear that Sentinel’s contributions may extend well beyond FDA’s medical product assessments. The tools and infrastructure that have been developed by FDA over the last four years could be used as a platform to establish a national resource for a more evidence-based learning health care system. This system will enable a better understanding of not only the risks, but also benefits and best uses, of drugs in the post-market settings. 

FDA has initiated steps to ensure the long-term sustainability and impact of Sentinel infrastructure and tools. Within the next few years, FDA has proposed that Sentinel be transitioned into three main components: the Sentinel Operations Center, the Nation Resource Data Infrastructure, and the Methodological Resource for Medical Product Surveillance using Electronic Healthcare Databases. FDA has indicated that while the Sentinel Operations Center will continue to serve as FDA’s portal to the distributed database, the Nation Resource Data Infrastructure could potentially be used by other groups to support broader evidence generation. Potential groups with interest in improving our understanding of the impact of medical products and who could benefit from this framework include the National Institutes of Health, the Regan-Udall Foundation, the Patient Centered Outcomes Research Institute, and other possible stakeholder groups, such as the private industry. 

Collectively, these components will ensure that FDA continues to have the tools to engage in medical product surveillance, while ensuring the long-term sustainability of the system. In just four years, the Sentinel Initiative has laid the groundwork to transform how FDA, and the nation, benefits from electronic health care data. This network continues to foster a community of stakeholders committed the evidence generation, which will ultimately contribute to a learning health care system.

For more information on these issues, including discussion by leaders from Sentinel stakeholders, please visit the Sentinel Initiative Public Workshop event page. There you will find archived video, presentations, and further reading.

Video

• New Advances in Medical Records Reflects the Realities of the U.S. Healthcare System