On May 17, Egyptian President Abdel-Fatah el-Sissi did something Egyptian presidents have done many times before: he urged Israel and the Palestinians to renew negotiations for peace, this time by backing an international conference promoted by the French foreign minister.

But what made Sissi’s call particularly interesting is that he called on not just the leaders but also political "parties" to seize what he called “a real opportunity to find a long-awaited solution.” Sissi's call offered Israeli Prime Minister Benjamin Netanyahu an opportunity to accommodate Israel's newest best friend, Sissi, rather than the French themselves. It would not have brought peace, of course: though an international conference would offer a glimmer of hope to change some of the worst aspects of the current diplomatic deadlock, it would not solve any of the outstanding substantive issues between Israelis and Palestinians.

Sissi's reference to political parties was no coincidence: it fit perfectly with the domestic political needs of Netanyahu and of Opposition Leader Isaac Herzog, who were angling to bring the Zionist Union joint list into the government and give Netanyahu a much-needed parliamentary cushion beyond his current razor-thin coalition. 

Herzog first had to convince his own highly-reluctant party of the need to join its rival Netanyahu—and if peace was about to break out, how could they refuse? For about 48 hours it seemed like Herzog was indeed about to announce his decision to join the coalition, face the battle in his party, and become Israel's foreign minister.

Then something else happened. Rather than appointing Herzog as foreign minister, Netanyahu is now poised to bring back Avigdor Lieberman, a former foreign minister and Israel's least diplomatic politician. Lieberman won't be returning to diplomacy, however. Instead, he will get a significantly more powerful position, second only to the prime minister: minister of defense. In response, current Minister of Defense Moshe Ya’alon today resigned from the cabinet and the Knesset, refusing to take another cabinet position. He gave a scathing speech, saying that "[E]xtremist and dangerous forces have taken over Israel and the Likud movement."

In what can only be considered brilliant politicking—and reckless policy—Netanyahu jettisoned Ya’alon and Herzog in favor of his former associate and bitter personal rival, Lieberman.

In what can only be considered brilliant politicking—and reckless policy—Netanyahu jettisoned Ya’alon and Herzog in favor of his former associate and bitter personal rival, Lieberman. Herzog is left wounded and humiliated, played for a fool—the gravest sin in Israeli political culture. Netanyahu finds himself at the helm of an enlarged coalition (Lieberman brings with him five members of Knesset, after one member of his faction left the party today in protest of the move), safer from parliamentary shocks and from attacks from the right (the whole right wing is now inside the coalition. Lieberman will still likely criticize Netanyahu from within the government, but not quite as fiercely). 

A cynics’ cynic

Lieberman's pending appointment has been met with astonishment by the opposition in Israel, by many in the military which he will oversee, and indeed here in Washington—and with good reason.

Just these past few months, Lieberman has viciously attacked both Netanyahu and the military brass for what he claimed was a weak response to terrorist attacks. In but one example of many, Lieberman came to the defense of a soldier who the Israel Defense Forces (IDF) had decided to prosecute for killing a Palestinian assailant who had already been thoroughly subdued. The contrast to current Minister of Defense Moshe Ya’alon is striking: Ya’alon defended the military's decision and stressed the importance of ethical norms and of rules of engagement in the military. Ya’alon is very right wing on the Palestinian issue, but he has consistently shown an honorable stance in the face of attacks on democratic norms. 

Lieberman is ostensibly less right-wing on the Palestinian issue—sometimes. Though he is a settler himself, he has endorsed a two-state solution in very general theory, noting he would even move if peace necessitated it. His endorsement, however, has always been couched in the toughest language possible and in utter mistrust of Palestinian intentions or the chances of peace ever materializing. On the niceties of democratic norms, including military law, he is a cynics' cynic. Benny Begin, another former Likud minister and an avowed hawk, has called Lieberman's appointment “delirious.”

As minister of defense, these positions will be highly consequential. Not only will he be in charge of the military brass and its promotion, but he will have statutory authority over many affairs in the West Bank, which is under military rule. Any attempt to improve the daily lives of Palestinians (such as a project just announced to streamline checkpoints for Palestinians) will be under his purview. His open calls to bring down Hamas through a ground invasion of Gaza if there is another round of fighting with Hamas—voiced even while he was a cabinet member during the last round of fighting—will now carry the weight of the minister of defense.

What was Herzog thinking? 

For the past year, since Netanyahu formed his fourth government, Herzog had denied time and again that he was aiming to join Netanyahu rather than replace him. He bemoaned the cynicism of those who simply would not believe him. This week the masks came off. Negotiations between the sides were accelerated and Herzog began a difficult intra-party fight to justify such a move. "National unity" governments are quite common in Israel, starting with the emergency cabinet of 1967, on the eve of the Six-Day War, when a sense of imminent doom swept the country. 

These governments, however, are usually justified by either an acute crisis, like in 1967, or in order to resolve a political deadlock, such as between Shimon Peres' Labor and Yitzhak Shamir's Likud in 1984. Peres and Shamir even "rotated" the post of prime minister. Though the government was incapable of any meaningful diplomatic advances, on which it was divided, it succeeded in tackling hugely important challenges in the economy—bringing inflation down from an annual rate of over 444 percent (not a typo) in 1984, and in defense—extricating Israel from most of Lebanon, following the first Israeli Lebanon War. 

What would be the logic this time? Herzog was promising three things to his party members: a host of portfolios (jobs and titles but also influence on a range of domestic policy issues); a veto on some aspects of policy which Labor finds most damaging, including remote settlement construction and legislation seen as limiting democratic discourse in Israel; and a leading role in any negotiations with the Palestinians, staring with the French peace conference. 

The jobs for Labor would have been real. A veto on policy could have been important—Tzipi Livni, Herzog's non-Labor partner in the Zionist Union, played a crucial role in protecting democratic norms as minister of justice in Netanyahu's previous government. 

On peace, however, Herzog was offering fool's gold. Put it this way: if you think Herzog would have real autonomy to run negotiations with the Palestinians while Netanyahu is prime minister, I have two suggestions. First, ask Tzipi Livni, who had that exact task in the previous government and was accompanied to every negotiation by Netanyahu’s personal lawyer, Yitzhak Molcho. Livni, incidentally, was strongly opposed to joining Netanyahu this time around. 

Second, I have some great real-estate in a swamp in Florida I'd like to discuss with you.

Herzog had a political rationale as well. He is a natural minister and backroom politician: smart, hardworking and prone to pragmatic compromises. He is not a natural public politician. As Leader of the Opposition he has wowed no one with his charisma or ability to stand up to Netanyahu and offer a bold alternative. Better to be in the halls of power than in the open arena. With the prospects of a fierce leadership challenge in his own Labor Party, moreover, he would have bolstered his bona fides as a national leader and therefore give himself a bit more time—the most a politician in Israel can really hope for. 

If there was a political benefit to Herzog personally, the outlook for his Labor Party would have been dismal.

If there was a political benefit to Herzog personally, the outlook for his Labor Party would have been dismal. Having joined Netanyahu, it would have been very hard to present the party as an alternative to his rule. 

What now?

Netanyahu can now feel slightly more secure in his coalition, though once again at the mercy of the mercurial Lieberman. Lieberman will enjoy a powerful post that usually bestows its occupant with new popularity in Israel (the converse is true of the finance ministry). Finance Minister Moshe Kahlon will enjoy a wider coalition to pass his domestic legislation and budget; indeed he'd been pushing for enlarging the coalition since it was formed. 

In the opposition, Herzog is weaker than ever. After being led on by Netanyahu for months, breaking his own word on the negotiations and then losing his gamble, he is severely exposed to challenges within Labor. His party's image has taken a serious hit as well.

Herzog's weakness will allow others in the opposition to claim the mantle of alternative to Netanyahu. Already, Yair Lapid’s centrist Yesh Atid party is the main beneficiary, but others may emerge as well, especially from the ranks of former generals like Gabi Ashkenazi. 

Most importantly, Israel's actual policy may be affected significantly by this move. Of all the governmental posts, defense is the one that has the most effect on the crucial questions of security for Israelis (and on the daily lives of Palestinians). Instead of grand peace plans Herzog was selling, Netanyahu's political brilliance has wrought one of the most hardline governments Israel has ever had.

Are Turkey and Israel on the verge of signing a normalization agreement, after a six-year hiatus? Comments in recent days by senior officials in both countries suggest so. A senior Israeli official, quoted in the Times of Israel, stated that “95% of the agreement is completed,” while Turkish Foreign Minister Mevlüt Çavuşoğlu said the parties are “one or two meetings away” from an agreement.

Media outlets in both countries have revealed that a meeting between senior Turkish and Israeli officials is expected to be held in Turkey on June 26—and that shortly after, an agreement is likely to be signed and go into effect. 

For two of America’s closest allies in the Middle East to bury the hatchet, reinstate ambassadors, and resume senior-level dialogue would surely be a boost for U.S strategic interests in the region. It would contribute to greater cohesion in dealing with the Syrian crisis, for example, and in the fight against the Islamic State. 

A quick recap

Let’s first recall how the crisis between the two former strategic allies developed, when in the aftermath of the Mavi Marmara incident (May 31, 2010)—resulting in the deaths of 9 Turks—Turkey recalled its ambassador in Tel Aviv and suspended nearly all defense and strategic ties with Israel. Israel also called back its ambassador in Ankara. At the time, Turkey set three conditions for resuming dialogue with Israel: a formal apology, compensation for the families of the victims, and a removal of Israel’s Gaza naval blockade. Relations came to a practical standstill, except in the economic sphere: trade between the two countries exceeded $5 billion in 2014, an unprecedented level. 

Israel formally apologized to Turkey in 2013 and in 2014 committed to paying compensation to the families of the victims. But the Gaza naval blockade has not been lifted. Turkey further demands greater access and presence in Gaza. For its part, Israel demands that Turkey not allow Hamas operative Salah al-Arouri, who resides in Istanbul, to coordinate terrorist operations against Israeli targets in the West Bank. Israel also wants Ankara to pressure Hamas to return the remains of two Israeli soldiers killed in the 2014 war in Gaza. 

Since the flotilla incident, Turkey was not always convinced that repairing relations with Israel actually served its interests. As the Arab Spring unfolded, Turkey hoped to assume a leadership role in the Arab and Muslim worlds—having good relations with Israel did not serve that purpose. And as Turkey went through periods of some unrest in the political arena (whether during the Gezi Park protests in 2013 or the hotly contested local and national elections), many in the ruling AKP party saw restoring relations with Israel as a potential liability in domestic politics. Israel, for its part, was mostly in a reactive mode: sometimes it tried to initiate contacts with Turkey, and sometimes it denounced Turkish anti-Israeli or anti-Semitic rhetoric.

The times they are a-changing

Now, however, new developments have prompted Turkey to seek a rapprochement with Israel. One key factor is the crisis in the Turkish-Russian relationship—in the aftermath of the suspension of the Turkish Stream natural gas pipeline project, Israeli natural gas is viewed as a possible substitute in the medium term for some of Turkey’s natural gas imports from Russia. And as the impact of the war in Syria on Turkey (including the refugee crisis and terrorist attacks) has made clear to Turkey that it must enhance its intelligence capabilities, and Israel can help. Israel, meanwhile, is searching for an export destination for its natural gas (Israeli Energy Minister Steinitz stated recently that “Turkey is a huge market for gas…they need our gas and we need this market”). Israeli leaders also know that resuming a political and military dialogue with Turkey may contribute to a more comprehensive view of the challenges Israel faces in the region. 

Five years after Israel’s formal request to open a representation office at NATO’s Brussels headquarters, Israeli Prime Minister Benjamin Netanyahu announced last month that NATO has approved the Israeli request. Turkey had opposed it, blocking progress, since NATO decisions are adopted by consensus. In a move seen signaling a thawing of relations, Turkey recently removed its objection to Israel’s request, paving the way to NATO’s decision. Israel continues to be a partner in NATO’s Mediterranean Dialogue along with Egypt, Algeria, Tunisia, Jordan, Mauritania and Morocco. 

At a time when Turkish President Recep Tayyip Erdoğan is attempting to strengthen his country’s regional strategic position and enhance its economic opportunities, a rapprochement with Israel makes sense. Bilateral negotiations are in the final stretch, as they have reached a compromise on the complex issue of Gaza and Hamas (Turkey will reportedly not demand the full lifting of Israel’s naval blockade on Gaza, settling for greater access and presence in Gaza. Israel will acquiesce to continued Hamas political activities in Turkey and will not demand the removal of Hamas operative al-Arouri from Turkey, but will get Turkish assurances that al-Arouri’s involvement in terror will cease.)

Fixing the troubled Turkish-Israeli relationship has been a mighty task for senior negotiators on both sides over the last few years, and although an agreement seems around the corner, the experience of recent years suggests that there can be last minute surprises. Israel’s Prime Minister had to jump over several hurdles, holding off pressure from Russia and Egypt not to seek rapprochement with Turkey, and ensuring support of the deal with Turkey from his newly appointed Defense Minister Avigdor Liberman, a known opponent of a deal. On the Turkish side, it seems that President Erdoğan wants a rapprochement with Israel, and feels that he needs it. This is tied directly to the Turkish domestic arena: Erdoğan has recently completed his consolidation of power, ousting Prime Minister Ahmet Davutoğlu and paving the way to the election of his trusted confidant, Binali Yıldırım, as prime minister. In addition, his new allies—the military-judicial establishment—are in favor of mending ties with Israel. One caveat is that Erdoğan’s top priority is establishing a presidential system, and so if he feels at any point that reaching an agreement with Israel will somehow undermine those efforts, he may opt for maintaining the status quo. 

Event Information

As policy agendas for 2015 come into sharper focus, much of the national conversation is aimed at tackling challenges in biomedical innovation. The first two months of the year alone have seen landmark proposals from Congress and the Obama Administration, including the House’s 21^st Century Cures initiative, a bipartisan Senate working group focused on medical progress, President Obama’s Precision Medicine Initiative and a number of additional priorities being advanced by federal agencies and other stakeholders.

On March 13, the Engelberg Center for Health Care Reform hosted the State of Biomedical Innovation Conference to provide an overview of emerging policy efforts and priorities related to improving the biomedical innovation process. Senior leaders from government, academia, industry, and patient advocacy shared their thoughts on the challenges facing medical product development and promising approaches to overcome them. The discussion also examined the data and analyses that provide the basis for new policies and track their ultimate success.

 Join the conversation by following @BrookingsMed or #biomed

Video

• State of biomedical innovation conference: Panel 1
• State of biomedical innovation conference: Panel 2

Audio

• State of biomedical innovation conference

Transcript

• Uncorrected Transcript (.pdf)

Event Materials

• 20150313_biomed_transcript
• 313 MASTER DECK2

Breakthrough therapy designation (BTD) is the newest of four expedited programs developed by the U.S Food and Drug Administration (FDA) to accelerate the development and review of novel therapies that target serious conditions. The public response to the program has been largely positive, and dozens of drugs have successfully received the designation. However, the FDA denies many more requests than it grants. In fact, as of March 2015, less than one in three of the BTD requests submitted have been granted. By contrast, roughly 75 percent of the requests for fast track designation (another of the Agency’s expedited programs) were granted between 1998 and 2007. This discrepancy suggests ongoing uncertainty over what exactly constitutes a “breakthrough” according to the FDA’s criteria.

On April 24, the Center for Health Policy at Brookings will host an event, Breakthrough Therapy Designation: Exploring the Qualifying Criteria, that will discuss qualifying criteria for the BTD program using real and hypothetical case studies to explore how FDA weighs the evidence submitted. Below is a primer that describes the definition, value, and impact of BTD.

What is BTD?

BTD was established in 2012 under the Food and Drug Administration Safety and Innovation Act, and is intended to expedite the development and review of drugs that show signs of extraordinary benefit at early stages of the clinical development process. However, BTD is not an automatic approval. The drug still has to undergo clinical testing and review by the FDA. Rather, BTD is designed to facilitate and shorten the clinical development process, which can otherwise take many years to complete.

What criteria does FDA use to evaluate potential breakthroughs?

In order to qualify for the designation, a therapy must be intended to treat a serious or life-threatening illness, and there must be preliminary clinical evidence that it represents a substantial improvement over existing therapies on at least one clinically significant outcome (such as death or permanent impairment).

In considering a request for BTD, FDA relies on three primary considerations:

1) the quantity and quality of the clinical evidence being submitted;

2) the available therapies that the drug is being compared to; and

3) the magnitude of treatment effect shown on the outcome being studied.

In practice, however, it can be difficult to define a single threshold that a therapy must meet. The decision depends on the specific context for that drug.  In some cases, for example, the targeted disease has few or no treatments available, while in others there may be several effective alternative treatments to which the new therapy can be compared. The request may also be made at different stages of the clinical development process, which means that the amount and type of data available to FDA can vary. In some cases, early evidence of benefit may disappear when the drug is tested in larger populations, which is why FDA reserves the right to rescinded the designation if subsequent data shows that the therapy no longer meets the criteria.

How many therapies have received the designation?

As of March 2015, FDA had received a total of 293 requests for BTD. Of these, 82 received the designation, and 23 have since been approved for marketing. Ten of these approvals were new indications for already approved drugs, rather than novel therapies that had never before received FDA approval.

What are the benefits of BTD?

For drug manufacturers, it is about the intensity and frequency of their interactions with FDA. Once the designation is granted, the FDA takes an “all hands-on-deck” approach to providing the manufacturer with ongoing guidance and feedback throughout the clinical development process. Products that receive BTD are also able to submit portions of their marketing application on a rolling basis (rather than all at once at the end of clinical trials) and BTD can also be used in combination with other expedited programs in order to further reduce the product’s time to market.

For patients, the potential benefits are straightforward: earlier access to therapies that may significantly improve or extend their lives.

How does BTD relate to the other three expedited programs?

The other three expedited review and development programs—fast track designation, priority review, and accelerated approval—are also geared at facilitating the development and approval of drugs for serious conditions. These other programs have been in place for over 15 years, and have played a significant role in accelerating patient access to new therapeutics (Table 1). In 2014 alone, 66 percent of the 41 drugs approved by FDA's Center for Drug Evaluation and Research used at least one of these four pathways, and 46 percent received at least two of the designations in combination.

Table 1: Overview of FDA’s Expedited Review Programs

 Adapted from FDA's Guidance for Industry: Expedited Programs for Serious Conditions - Drugs and Biologics

Event Information

Established by the Food and Drug Administration Safety and Innovation Act of 2012, breakthrough therapy designation (BTD) is one of several programs developed by the U.S. Food and Drug Administration (FDA) to speed up the development and review of drugs and biologics that address unmet medical needs. In order to qualify for this designation, the treatment must address a serious or life-threatening illness. In addition, the manufacturer (i.e., sponsor) must provide early clinical evidence that the treatment is a substantial improvement over currently available therapies. The FDA is working to further clarify how it applies the qualifying criteria to breakthrough designation applications.

On April 24, under a cooperative agreement with FDA, the Center for Health Policy convened a public meeting to discuss the qualifying criteria for this special designation. Using examples from oncology, neurology, psychiatry, and hematology, the workshop highlighted considerations for the BTD application process, the evaluation process, and factors for acceptance or rejection. The discussion also focused on key strategies for ensuring that the qualifying criteria are understood across a broad range of stakeholder groups.

Video

• Breakthrough therapy designation: Two and a half years in
• Applying the breakthrough therapy criteria: Oncology
• Applying the breakthrough therapy criteria: Neurology
• Applying the breakthrough therapy criteria: Anti-infective/psychiatry/hematology
• Summary and discussion of lessons learned

Event Materials

• Breakthrough Therapy Designation_final
• Breakthrough therapy slide deck

Many proposals to accelerate and improve medical product innovation and regulation focus on reforming the product development and regulatory review processes that occur before drugs and devices get to market. While important, such proposals alone do not fully recognize the broader opportunities that exist to learn more about the safety and effectiveness of drugs and devices after approval. As drugs and devices begin to be used in larger and more diverse populations and in more personalized clinical combinations, evidence from real-world use during routine patient care is increasingly important for accelerating innovation and improving regulation.

First, further evidence development from medical product use in large populations can allow providers to better target and treat individuals, precisely matching the right drug or device to the right patients. As genomic sequencing and other diagnostic technologies continue to improve, postmarket evidence development is critical to assessing the full range of genomic subtypes, comorbidities, patient characteristics and preferences, and other factors that may significantly affect the safety and effectiveness of drugs and devices. This information is often not available or population sizes are inadequate to characterize such subgroup differences in premarket randomized controlled trials.

Second, improved processes for generating postmarket data on medical products are necessary for fully realizing the intended effect of premarket reforms that expedite regulatory approval. The absence of a reliable postmarket system to follow up on potential safety or effectiveness issues means that potential signals or concerns must instead be addressed through additional premarket studies or through one-off postmarket evaluations that are more costly, slower, and likely to be less definitive than would be possible through a better-established infrastructure. As a result, the absence of better systems for generating postmarket evidence creates a barrier to more extensive use of premarket reforms to promote innovation.

These issues can be addressed through initiatives that combine targeted premarket reforms with postmarket steps to enhance innovation and improve evidence on safety and effectiveness throughout the life cycle of a drug or device. The ability to routinely capture clinically relevant electronic health data within our health care ecosystem is improving, increasingly allowing electronic health records, payer claims data, patient-reported data, and other relevant data to be leveraged for further research and innovation in care. Recent legislative proposals released by the House of Representatives’ 21st Century Cures effort acknowledge and seek to build on this progress in order to improve medical product research, development, and use. The initial Cures discussion draft included provisions for better, more systematic reporting of and access to clinical trials data; for increased access to Medicare claims data for research; and for FDA to promulgate guidance on the sources, analysis, and potential use of so-called Real World Evidence. These are potentially useful proposals that could contribute valuable data and methods to advancing the development of better treatments.

What remains a gap in the Cures proposals, however, is a more systematic approach to improving the availability of postmarket evidence. Such a systematic approach is possible now. Biomedical researchers and health care plans and providers are doing more to collect and analyze clinical and outcomes data. Multiple independent efforts – including the U.S. Food and Drug Administration’s Sentinel Initiative for active postmarket drug safety surveillance, the Patient-Centered Outcomes Research Institute’s PCORnet for clinical effectiveness studies, the Medical Device Epidemiology Network (MDEpiNet) for developing better methods and medical device registries for medical device surveillance and a number of dedicated, product-specific outcomes registries – have demonstrated the potential for large-scale, systematic postmarket data collection. Building on these efforts could provide unprecedented evidence on how medical products perform in the real-world and on the course of underlying diseases that they are designed to treat, while still protecting patient privacy and confidentiality.

These and other postmarket data systems now hold the potential to contribute to public-private collaboration for improved population-based evidence on medical products on a wider scale. Action in the Cures initiative to unlock this potential will enable the legislation to achieve its intended effect of promoting quicker, more efficient development of effective, personalized treatments and cures.

Downloads

• Download paper

The breakthrough therapy designation (BTD) program was initiated by the U.S. Food and Drug Administration (FDA) in 2012 to expedite the development of treatments for serious or life-threatening illness that demonstrate “substantial improvement” over existing therapies. The program has since become a widely supported mechanism for accelerating patient access to new drugs. As of March 2015, FDA has received a total of 293 requests for BTD. However, it has granted just  82 (28%), which indicates an ongoing lack of clarity over what exactly meets the criteria for the designation.

On April 24, the Center for Health Policy at Brookings convened a public meeting to explore the designation’s qualifying criteria and how FDA applies those criteria across therapeutic areas. Panelists used real-world and hypothetical case studies to frame the discussion, and highlighted major considerations for the application process, the FDA’s evaluation of the evidence, and the key factors for acceptance or rejection. The discussion also identified strategies to ensure that qualifying criteria are well understood. Here are the five big takeaways:

1.  The BTD program is viewed positively by drug companies, researchers, advocates, and others 

Across the board, participants expressed enthusiasm for the BTD program. Industry representatives noted that their experience had been extremely positive, and that the increased cooperation with and guidance from FDA were very helpful in streamlining their development programs. Receiving the designation can also raise a drug company’s profile, which can facilitate additional investment as well as clinical trial patient recruitment; this is particularly important for smaller companies with limited resources.

Patient and disease advocates were likewise supportive, and expressed hope that the early lessons learned from successful breakthrough therapy approvals (which have been mostly concentrated in the oncology and antiviral fields) could be translated to other disease areas with less success. However, while BTD is an important tool in expediting the development of new drugs, it is just one piece of broader scientific and regulatory policy landscape. Accelerating the pace of discovery and development of truly innovative new drugs will depend on a range of other factors, such as developing and validating new biomarkers that can be used to measure treatment effects at an earlier stage, as well as establishing networks that can streamline the clinical trial process. It will also be important to develop effective new approaches to collecting, analyzing, and communicating information about these treatments once they are on the market, as this information can potentially be used by FDA, providers, and patients to  further improve prescription drug policy and medical decision-making.

2.  BTD requests far outnumber those that actually meet the qualifying criteria

Since the program began, less than 30 percent of requests have received BTD designation. A substantial majority were denied at least in part due to either a lack of data or problems with the quality of the data, or some combination of the two. For example, some sponsors requested the designation before they had any clinical data, or submitted the request using clinical data that was incomplete or based on flawed study designs. Many requests also failed to meet the Agency’s bar for “substantial improvement” over existing therapies.

One reason for the high denial rate may be a lack of a clear regulatory or statutory bar that could be used as a definitive guide for sponsors to know what is needed to qualify for the designation. BTD denials are also confidential, which means that sponsors effectively have nothing to lose by submitting a request. Going forward, manufacturers may need to exercise more discretion in deciding to request the designation, as the process can be resource- and time-intensive for both sides.

3.  There is no single threshold for determining what defines a breakthrough therapy

About 53 percent of the 109 total BTD denials were due at least in part to the fact that the drug did not represent a substantial improvement over existing therapies. During the day’s discussion, FDA and sponsors both noted that this is likely because the criteria for BTD are inherently subjective. In practice, this means there is no clear threshold for determining when a new therapy represents a “substantial improvement” over existing therapies. Designation decisions are complex and highly dependent on the context, including the disease or condition being targeted, the availability of other treatments, the patient population, the outcomes being studied, and the overall reliability of the data submitted. Given the multiple factors at play, it can be difficult in some cases to determine when a new product is potentially “transformational” as opposed to “better,” especially for conditions that are poorly understood or have few or no existing treatments. In making its determinations, FDA considers the totality of the evidence submitted, rather than focusing on specific evidentiary requirements.

4.  Early communication with FDA is strongly recommended for BTD applicants

Roughly 72 percent of the BTD denials related at least in part to trial design or analysis problems, which led several people to suggest that sponsors engage with FDA prior to submitting their request. Though there are several formal mechanisms for interacting with the agency, informal consultations with the relevant review division could help sponsors to get a better  and much earlier sense of what kind of data FDA might need. This early communication could both strengthen viable BTD requests and reduce the number of frivolous requests.

5.  FDA may need more resources for implementing the BTD program

Event Information

The Risk Evaluation and Mitigation Strategies (REMS) program has become an important tool of the U.S. Food and Drug Administration (FDA) in ensuring that the benefits of a given medical product outweigh the associated risks, and has enabled FDA to approve a number of products that might not otherwise have been made available for patient use. Since the implementation of the REMS program, however, concerns have been raised regarding its impact on patient access to products and the associated burden on providers and health care systems. In an effort to address these concerns—and as part of its commitments under the Prescription Drug User Fee Act reauthorization of 2012—FDA has undertaken efforts to standardize and improve the effectiveness of REMS, and to better integrate REMS programs into the health system. As part of this broader initiative, the Agency is currently assessing the feasibility of integrating accredited continuing education (CE) programs and activities into REMS programs that have been developed for a single drug.

Under a cooperative agreement with the FDA, the Center for Health Policy held an expert workshop on May 18, titled “Incorporating Continuing Education into Single-Drug REMS: Exploring the Challenges and Opportunities”. This workshop provided an opportunity for pharmaceutical manufacturers, regulators, CE providers, accreditors, and other stakeholders to explore the ways that CE can be a valuable addition to the REMS toolkit, discuss potential barriers to the development and implementation of REMS-related CE for single products, and identify strategies for addressing those barriers.

Event Materials

• Bio sheet
• REMS CE Meeting Agenda
• REMS_CE_Meeting_Discussion_Guide_Final
• REMS CE Meeting Summary

For the last several years, the US government has been negotiating a free-trade agreement known as the Trans-Pacific Partnership (TPP) with 11 other countries across the Asia-Pacific and Latin American regions, which could have major impact on the pharmaceutical market.  When finalized it will be the largest free-trade agreement in history, impacting up to one-third of world trade and roughly 40 percent of the global gross domestic product. The deal has attracted a fair share of criticism from a wide range of groups, including concerns over proposed regulations for biologic drugs in participating countries. Specifically, critics are concerned about the length of data exclusivity granted to the companies that hold the patents on these drugs. Below is a primer on biologics and how they are being addressed in the TPP.

Biologic drugs include any therapy derived from a biological source; a group which includes vaccines, anti-toxins, proteins, and monoclonal antibodies. Because they are typically much larger and more structurally complex than traditional ‘small-molecule’ drugs, they are also more difficult—and much more costly—to develop and manufacture. Biologics are also among the most expensive drugs on the market, costing an average of 22 times more than nonbiologic drugs. Avastin, a cancer drug, can cost more than $50,000 a year, while the rheumatoid arthritis drug Remicade can cost up to $2,500 per injection.

Given these high costs, there is substantial interest in encouraging the development of biosimilars, a term used to describe follow-on versions of an original biologic. Estimates of the potential cost savings vary substantially, but some have predicted that competition from biosimilars could reduce US spending on biologics by $44 to $66 billion over the next ten years.  In the European Union, biosimilars have been on the market since 2006, and a 2013 analysis found that, for the 14 biosimilars on the market, the average price discount was about 25 percent. By 2020, the overall cost savings are projected to total $16-$43 billion.

After the Affordable Care Act (ACA) was passed in 2010, the US Food and Drug Administration (FDA) developed an accelerated approval pathway for biosimilars, modeled after the pathway used for the approval of small-molecule generics. In order to meet the criteria for biosimilarity, the drug must share the same mechanism of action for the approved condition of use, and there must be no clinically significant differences between the two drugs in terms of purity, safety, or potency. FDA recently approved its first biosimilar, Zarxio, which is a copy of the oncology drug Neupogen.

Under current FDA regulations, biologic drugs are granted 12 years of data exclusivity following approval. During this period of exclusivity, the FDA may not approve a biosimilar application that relies on the data submitted as part of the original biologic application. This form of temporary monopoly is distinct from patent protection, which is granted well before approval and is not related to clinical data.  Data exclusivity does not prevent another company from generating the data independently, but drug companies are unlikely to go to the considerable (and costly) effort of replicating a full course of clinical trials for a drug that is already on the market. (Though biosimilars may need to undergo some additional clinical testing under current FDA regulations, the amount of data required to support approval would certainly be less than what is required for an original biologic approval.)

The 12-year exclusivity period for biologics was established in the ACA following intense debate, and has continued to attract criticism. (By contrast, the period of data exclusivity is just five years for small-molecule drugs.) Supporters argue that given the greater cost and difficulty of bringing a biologic to market a longer period of exclusivity is necessary to incentivize innovation. Others argue that the resulting restrictions on competition keep drug prices unnecessarily high, inevitably putting a strain on the health system and keeping potentially life-saving drugs out of reach for many patients.

For the 11 countries besides the U.S. that are involved in the TPP, current data exclusivity protections range from zero (Brunei) to eight years (Japan). Under the Obama Administration’s current proposal, participating countries would increase those periods to match the US standard of 12 years. Curiously, this proposal directly contradicts the administration’s ongoing domestic efforts to lower the period of data exclusivity. Since the ACA passed, the Obama administration has repeatedly proposed reducing it to seven, arguing that this would save Medicare $4.4 billion over the next decade. Some have noted that, once the 12-year period is enshrined in the TPP, it will become significantly more difficult to change it through the US legislative process. Furthermore, imposing US standards on the 11 member countries would inevitably restrict competition at the global level, and many patient advocacy and international humanitarian organizations have argued that doing so would undermine the efforts of US global health initiatives like the Vaccine Alliance and the Global Fund to Fight AIDS, Tuberculosis and Malaria, which rely on price competition to manage program costs.

It is unclear whether the US will be successful in its efforts. There have been reports that the issue of data exclusivity has become a significant point of contention, and the US delegation may seek to compromise on its demands. It may, for example, negotiate exceptions for the poorer countries involved in the negotiation, as the Washington Post notes. However, the details of the negotiations are largely confidential, which makes it challenging to assess the possibilities, their relative advantages, or how the US Trade Representative (which is leading the US negotiations) is balancing the need to ensure adequate incentives for innovation with the need to control drug costs and facilitate patient access to potentially life-saving therapies.

Editor's note: Elizabeth Richardson, a research associate in the Center for Health Policy, contributed to the research and writing of this post. 

The Risk Evaluation and Mitigation Strategies (REMS) program has become an important tool of the U.S. Food and Drug Administration (FDA) in ensuring that the benefits of a given medical product outweigh the associated risks, and has enabled FDA to approve a number of products that might not otherwise have been made available for patient use. Since the implementation of the REMS program, however, concerns have been raised regarding its impact on patient access to products and the associated burden on providers and health care systems. In an effort to address these concerns—and as part of its commitments under the Prescription Drug User Fee Act reauthorization of 2012—FDA has undertaken efforts to standardize and improve the effectiveness of REMS, and to better integrate REMS programs into the health system. As part of this broader initiative, the Agency is currently assessing the feasibility of integrating accredited continuing education (CE) programs and activities into REMS programs that have been developed for a single drug.

Under a cooperative agreement with the FDA, the Center for Health Policy held an expert workshop on May 18 titled, “Incorporating Continuing Education into Single-Drug REMS: Exploring the Challenges and Opportunities”. This workshop provided an opportunity for pharmaceutical manufacturers, regulators, CE providers, accreditors, and other stakeholders to explore the ways that CE can be a valuable addition to the REMS toolkit, discuss potential barriers to the development and implementation of REMS-related CE for single products, and identify strategies for addressing those barriers.

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Under the Food and Drug Administration Amendments Act (FDAAA) of 2007, the FDA has the authority to require pharmaceutical manufacturers to develop Risk Evaluation and Mitigation Strategies (REMS) for drugs or biologics that carry serious potential or known risks. Since that time, the REMS program has become an important tool in ensuring that riskier drugs are used safely, and it has allowed FDA to facilitate access to a host of drugs that may not otherwise have been approved. However, concerns have arisen regarding the effects of REMS programs on patient access to products, as well as the undue burden that the requirements place on the health care system. In response to these concerns, FDA has initiated reform efforts aimed at improving the standardization, assessment, and integration of REMS within the health care system. As part of this broader initiative, the agency is pursuing four priority projects, one of which focuses on improving provider-patient benefit-risk counseling for drugs that have a REMS attached.

Under a cooperative agreement with FDA, the Center for Health Policy at Brookings held an expert workshop on July 24 titled, “Risk Evaluation and Mitigation Strategies (REMS): Building a Framework for Effective Patient Counseling on Medication Risks and Benefits”. This workshop was the first in a series of convening activities that will seek input from stakeholders across academia, industry, health systems, and patient advocacy groups, among others. Through these activities, Brookings and FDA will further develop and refine an evidence-based framework of best practices and principles that can be used to inform the development and effective use of REMS tools and processes.

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The role of clinical pharmacology and experimental medicine

The high failure rate of investigational compounds during drug development, especially in late stages of the clinical development process, is widely seen as a key contributor to the outsize amount of time and resources necessary to develop new drugs. Advances in clinical pharmacology and experimental medicine have the potential to rebalance these trends by providing researchers with the tools to more efficiently and systematically identify promising targets and compounds, appropriate patient populations, and adequate doses for study much earlier in development. 

On July 28, the Center for Health Policy at Brookings, in collaboration with the International Consortium for Innovation & Quality in Pharmaceutical Development and the U.S. Food and Drug Administration (FDA), hosted a public meeting to tackle these issues. Through presentations and case studies, leading experts from industry, academia, and government agencies explored the evolving role of clinical pharmacology tools in pre-clinical and clinical development, existing gaps in the application of those tools, and how emerging science could be better leveraged to improve the efficiency of drug development programs and better optimize treatments. Discussion at this event will potentially be harnessed to inform downstream guidance documents, to establish best practices for the application of emerging clinical pharmacology tools, or to support academic publications. Speakers will convene privately to discuss such downstream deliverables and key takeaways from the conference.

Click here to access the full event agenda.

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• Introductory keynotes: Framing the issues
• Optimizing target and compound selection to enhance early stage decision-making
• The right dose for the right patient: Challenges and opportunities in dose optimization
• Precision medicine: Trial enrichment, biomarker science, and mechanistic reasoning to optimize patient selection
• Applications of clinical pharmacology to support demonstration of efficacy

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INTRODUCTION

In August, 2010 the government of Kenya adopted a new constitution. This followed a referendum in which an overwhelming majority of Kenyans voted for change. The decisive impetus for reform came from the widespread violence and political crisis that followed the 2007 election. While claims of electoral fraud provided the immediate catalyst for violence, the deeper causes were to be found in the interaction of a highly centralized ‘winner-take-all’ political system with deep social disparities based in part on group identity (Hanson 2008).

Provisions for equity figure prominently in the new constitution. Backed by a bill of rights that opens the door to legal enforcement, citizenship rights have been strengthened in many areas,including access to basic services. ‘Equitable sharing’ has been introduced as a guiding principle for public spending. National and devolved governments are now constitutionally required to redress social disparities, target disadvantaged areas and provide affirmative action for marginalized groups.

Translating these provisions into tangible outcomes will not be straightforward. Equity is a principle that would be readily endorsed by most policymakers in Kenya and Kenya’s citizens have provided their own endorsement through the referendum. However, there is an ongoing debate over what the commitment to equity means in practice, as well as over the pace and direction of reform. Much of that debate has centered on the constitutional injunction requiring ‘equitable sharing’ in public spending.

On most measures of human development, Kenya registers average outcomes considerably above those for sub-Saharan Africa as a region. Yet the national average masks extreme disparities—and the benefits of increased prosperity have been unequally shared.

There are compelling grounds for a strengthened focus on equity in Kenya. In recent years, the country has maintained a respectable, if less than spectacular, record on economic growth. Social indicators are also on an upward trend. On most measures of human development, Kenya registers average outcomes considerably above those for sub-Saharan Africa as a region. Yet the national average masks extreme disparities—and the benefits of increased prosperity have been unequally shared. Some regions and social groups face levels of deprivation that rank alongside the worst in Africa. Moreover, the deep fault lines running through society are widely perceived as a source of injustice and potential political instability.

High levels of inequality in Kenya raise wider concerns. There has been a tendency in domestic debates to see ‘equitable sharing’ as a guiding principle for social justice, rather than as a condition for accelerated growth and enhanced economic efficiency. Yet international evidence strongly suggests that extreme inequality—especially in opportunities for education— is profoundly damaging for economic growth. It follows that redistributive public spending has the potential to support growth.

The current paper focuses on a group of 12 counties located in Kenya’s Arid and Semi-Arid Lands (ASALs). They are among the most disadvantaged in the country. Most are characterized by high levels of income poverty, chronic food insecurity and acute deprivation across a wide range of social indicators.

Nowhere is the deprivation starker than in education. The ASAL counties account for a disproportionately large share of Kenya’s out-of-school children, pointing to problems in access and school retention. Gender disparities in education are among the widest in the country. Learning outcomes for the small number of children who get through primary school are for the most part abysmal, even by the generally low national average standards.

Unequal public spending patterns have played no small part in creating the disparities that separate the ASAL counties from the rest of Kenya—and ‘equitable sharing’ could play a role in closing the gap. But what would a more equitable approach to public spending look like in practice?

This paper addresses that question. It looks in some detail at education for two reasons. First, good quality education is itself a powerful motor of enhanced equity. It has the potential to equip children and youth with the skills and competencies that they need to break out of cycles of poverty and to participate more fully in national prosperity. If Kenya is to embark on a more equitable pattern of development, there are strong grounds for prioritizing the creation of more equal opportunities in education. Second, the education sector illustrates many of the wider challenges and debates that Kenya’s policymakers will have to address as they seek to translate constitutional provisions into public spending strategies. In particular, it highlights the importance of weighting for indicators that reflect need in designing formulae for budget allocations.

Our broad conclusion is that, while Kenya clearly needs to avoid public spending reforms that jeopardize service delivery in wealthier counties, redistributive measures are justified on the grounds of efficiency and equity.

The paper is organized as follows. Part 1 provides an overview of the approach to equity enshrined in the constitution. While the spirit of the constitution is unequivocal, the letter is open to a vast array of interpretations. We briefly explore the implications of a range of approaches. Our broad conclusion is that, while Kenya clearly needs to avoid public spending reforms that jeopardize service delivery in wealthier counties, redistributive measures are justified on the grounds of efficiency and equity. Although this paper focuses principally on basic services, we caution against approaches that treat equity as a matter of social sector financing to the exclusion of growth-oriented productive investment.

Part 2 provides an analysis of some key indicators on poverty, health and nutrition. Drawing on household expenditure data, the report locates the 12 ASAL counties in the national league table for the incidence and depth of poverty. Data on health outcomes and access to basic services provide another indicator of the state of human development. While there are some marked variations across counties and indicators, most of the 12 counties register levels of deprivation in poverty and basic health far in excess of those found in other areas.

Part 3 shifts the focus to education. Over the past decade, Kenya has made considerable progress in improving access to basic education. Enrollment rates in primary education have increased sharply since the elimination of school fees in 2003. Transition rates to secondary school are also rising. The record on learning achievement is less impressive. While Kenya lacks a comprehensive national learning assessment, survey evidence points to systemic problems in education quality. In both access and learning, children in the ASAL counties—especially female children—are at a considerable disadvantage. After setting out the national picture, the paper explores the distinctive problems facing these counties.

In Part 4 we look beyond Kenya to wider international experience. Many countries have grappled with the challenge of reducing disparities between less-favored and more-favored regions. There are no blueprints on offer. However, there are some useful lessons and guidelines that may be of some relevance to the policy debate in Kenya. The experience of South Africa may be particularly instructive given the weight attached to equity in the post-apartheid constitution.

Part 5 of the paper explores a range of approaches to financial allocations. Converting constitutional principle into operational practice will require the development of formulae-based approaches. From an equitable financing perspective there is no perfect model. Any formula that is adopted will involve trade-offs between different goals. Policymakers have to determine what weight to attach to different dimensions of equity (for example, gender, income, education and health), the time frame for achieving stated policy goals, and whether to frame targets in terms of outcomes or inputs. These questions go beyond devolved financing. The Kenyan constitution is unequivocal in stipulating that the ‘equitable sharing’ provision applies to all public spending. We therefore undertake a series of formula-based exercises illustrating the allocation patterns that would emerge under different formulae, with specific reference to the 12 ASAL focus counties and to education.

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EXECUTIVE SUMMARY

Parents, educators, government ministers and policymakers in all contexts and countries around the world are concerned with learning and how to improve it. There are many reasons for this, but none is more important than the fact that learning is at the heart of success at the individual, community and global levels. Learning First is the title of this report, with the strong implication that learning should be the foremost goal of education policies worldwide.

The present review seeks not only to explain why this is the case but also focuses on what we need to know—that is, what research is needed—in order to improve learning in the decades to come, particularly among those children most in need. This question is addressed in the following six sections.

1. Learning Goals and Research. The first section begins with a historical synopsis of international education goals put forward in 1990 at the World Conference on Education for All in Jomtien (Thailand), in 2000 at the Education for All conference in Dakar, and later in 2000 as a part of the UN Millennium Development Goals for 2015. In 2011, the Center for Universal Education at the Brookings Institution published A Global Compact on Learning: Taking Action on Education in Developing Countries, which stated that there is a “global learning crisis—which affects children and youth who are out of school with limited learning opportunities and those who are in school but not learning the skills they need for their futures.” The present review of learning research in low-income countries follows from that report. The overall purpose is to explore the most pressing learning issues today that require further research attention in the years to come.
    
2. Learning Definitions and Contexts. This section reviews how the field of education has defined learning over the years. Here, learning is defined as a modification of behavior due to experience—such as in knowledge, skills, attitudes and values. Three main principles of effective learning are suggested: individual active involvement, social participation, and meaningful engagement. As a way to emphasize the importance of learning contexts, three individual stories—Illa, a four-year-old Quechua-speaking girl in Peru; Pawan, an eight-year-old primary school student in urban India; and Rachida, a young illiterate woman in rural Morocco—are provided in order to better explain the importance of learning as a culturally specific phenomenon. These stories help to illustrate a more general learning framework, encompassing the relationship between two dimensions of learning—its processes and contexts. A discussion follows concerning the need to disaggregate learners and their learning contexts—between countries and within countries—as a way to overcome frequent and simplistic generalizations about how the “average” child learns.
    
3. Global Change and the Contexts of Learning. This section considers the issue of global change on how learning and learning contexts are being transformed around the world. For example, researchers need to pay more attention to the impact of migration on children’s learning and on educational systems more broadly. In each instance of translocation, children confront the challenges of adapting to a new environment that may include different languages, dialects or cultures within the nonformal learning contexts of daily life. Similarly, in formal education contexts, student migrants have to cope with contrasts in culture, lifestyle and language of schooling, and demonstrate skills and achievement that may vary dramatically with their culture of origin. Other changes due to globalization include increased multilingualism in schools, growing overcrowding in classrooms, inability to keep up with teacher training, changes in intergenerational learning, and the growing importance of 21st-century skills. Based on these observations, it is suggested that learning contexts and needs should be understood as a shifting target.

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May’s jobs gains, released this morning, show that only 38,000 new jobs were added this May, down from an average of 178,000 over the first four months of the year, and the least new jobs added since September 2010.

This year’s monthly job gains and losses can indicate how the economy is doing once they are corrected to account for the pattern we already expect in a process called seasonal adjustment. The approach for this seasonal adjustment that is presently used by the Bureau of Labor Statistics (BLS) puts very heavy weight on the current and last two years of data in assessing what are the typical patterns for each month.

In my paper “Unseasonal Seasonals?” I argue that a longer window should be used to estimate seasonal effects. I found that using a different seasonal filter, known as the 3x9 filter, produces better results and more accurate forecasts by emphasizing more years of data. The 3x9 filter spreads weight over the most recent six years in estimating seasonal patterns, which makes them more stable over time than in the current BLS seasonal adjustment method.

I calculate the month-over-month change in total nonfarm payrolls, seasonally adjusted by the 3x9 filter, for the most recent month. The corresponding data as published by the BLS are shown for comparison purposes. According to the alternative seasonal adjustment, the economy actually lost about 4,000 jobs in May (column Wright SA), compared to the official BLS total of 38,000 gained (column BLS Official).

In addition to seasonal effects, abnormal weather can also affect month-to-month fluctuations in job growth. In my paper “Weather-Adjusting Economic Data” I and my coauthor Michael Boldin implement a statistical methodology for adjusting employment data for the effects of deviations in weather from seasonal norms. This is distinct from seasonal adjustment, which only controls for the normal variation in weather across the year. We use several indicators of weather, including temperature and snowfall.

We calculate that weather in May had a negligible effect on employment, bringing up the total by only 4,000 jobs (column Weather Effect). Our weather-adjusted total, therefore, is 34,000 jobs added for May (column Boldin-Wright SWA). This is not surprising, given that weather in May was in line with seasonal norms.

Unfortunately, neither the alternative seasonal adjustment, nor the weather adjustment, makes todays jobs report any more hopeful. They make little difference and, if anything, make the picture more gloomy.

a. Applies a longer window estimate of seasonal effects (see Wright 2013).
b. Includes seasonal and weather adjustments, where seasonal adjustments are estimated using the BLS window specifications (see Boldin & Wright 2015). The incremental weather effect in the last column is the BLS official number less the SWA number.

Federal Reserve chair Janet Yellen just gave a speech in Philadelphia that acknowledges a weak jobs report last Friday. She rightly cautions us not to place too much weight on any single month’s numbers. Overall, her talk seems to have raised confidence in the financial markets about where the economy is heading, based on a wider range of recent indicators besides the numbers reported in the jobs report, for example, on consumer spending and home construction. These suggest areas of continued strength in the economy.

Still, the report last Friday was really lousy, and not really a one-off event (and not just due to the Verizon strike). Since the end of 2015, the job growth numbers have been on a pretty steady downward trend, with growth above 200,000 in only one month (February). A few other indicators in the report were also quite disappointing: the numbers of workers in part-time jobs because they can’t find full-time work bounced back up; and labor force participation dropped considerably. Indeed, about 800,000 workers have left the labor force in the last 2 months, including many who are well below retirement age. Their exit reverses some of the progress in labor force participation we had seen late last year and early this year.

On the other hand, not all numbers in the report were terrible. Wage growth held up reasonably well. Over the past 2 months, wages have risen by over 3 percent (on an annualized basis), suggesting a labor market that is tight enough to finally generate some earnings improvements for workers who already have jobs.

Overall, the different indicators highlight two sets of forces driving the labor market: Demand-side problems, suggesting employers still need too few workers to generate full employment; and supply-side problems, where worker availability and skills are starting to constrain the amount of hiring going on.

Indeed, the latter problems might explain the peculiar combination of weak and strong indicators we see in the report. For instance, if the drop in labor force participation is permanent, then the 4.7 percent unemployment rate accurately suggests that the amount of slack in the labor market is lower than we thought. Employers are likely finding it a bit harder to hire the workers with the skills and experience they really want. Consequently, our long economic expansion is finally translating into higher wage growth for those already employed or about to be.

Another possibility, perhaps, is that productivity growth is finally rebounding a bit, after the dismal numbers we’ve observed in the past few years, where GDP growth has been modest but employment growth has been strong. Indeed, some recovery in productivity is a precondition for real wage growth to last, even in a tighter labor market. In this scenario, output growth would now be more robust than employment growth, reversing some of the striking declines we’ve observed in the productivity numbers.

Of course, what might be most convincing is a combination of the labor demand- and supply-side stories, along the following lines: the labor market is gradually approaching capacity, though it is not there yet. I don’t think it will get there until we are closer to 4 percent unemployment. But employer difficulties finding skilled workers matter more in this type of market than in the earlier years of recovery after the Great Recession. Such pressure raises wages for employed workers and those with appropriate skill levels. On the other hand, workers with weaker skills still face dismal prospects, and their exit from the labor force reflects their bleak prospects. The growth of labor demand might really be shrinking, as productivity rebounds a bit and as weakness in business investment and export demand are felt in the job market.

We won’t know for sure how much of this story is accurate until we get more jobs and productivity reports over the next few months. But, in the meantime, my bet is on just such a mixed reading, which suggests that a very gradual lifting of economic stimulus is appropriate, without, however, moving too quickly in the opposite direction.

Ghana attained middle-income status after rebasing its National Accounts, pushing per capita gross domestic product (GDP) of the country above $1,000 in 2007. After recovering from economic recession in 1984 on account of the Bretton Woods sponsored economic reform introduced at that time, Ghana’s growth has been remarkably strong, with its lowest economic growth of 3.3 percent recorded in 1994. The country’s growth rate reached its peak of 15 percent in 2011 on the back of the commencement of commercial production of oil, making it one of the fastest growing economies globally during that year. This has translated into increased per capita income, which reached a high of about $1,900 in 2013.

The concern, however, has been the ability of the country to sustain this growth momentum given the level and quality of education and skills, and, more importantly, the failure of this strong growth performance to be translated into the creation of productive and decent jobs, improved incomes and livelihoods. The structure of the economy remains highly informal, with a shift in the country’s national output composition from agriculture to low-value service activities in the informal sector. The commencement of commercial production of oil raised the share of the industrial sector in national output. However, the continuous decline in manufacturing value added undermines Ghana’s economic transformation effort to promote high and secure incomes and improve the livelihoods of the people.

Structural change towards higher value added sectors, and upgrading of technologies in existing sectors, is expected to allow for better conditions of work, better jobs, and higher wages. But the low level and quality of human resources not only diverts the economy from its structural transformation path of development but also makes it difficult for the benefits of growth to be spread through the creation of gainful and productive employment. Thus, productive structural economic transformation hinges on the level and quality of education and labor skills. A highly skilled, innovative and knowledgeable workforce constitutes a key ingredient in the process of structural economic transformation, and as productive sectors apply more complex production technologies and research and development activities increase the demand for education and skills. However, the observed weak human capital base does not provide a strong foundation for structural economic transformation of Ghana.

Ghana’s employment growth lags behind economic growth, with an estimated employment elasticity of output of 0.47, suggesting that every 1 percent of annual economic growth yields 0.47 percent growth of total employment.

There is also widespread concern about the quality of the country’s growth in terms of employment and inequality, as well as general improvement in the livelihood of the people (see Alagidede et al. 2013; Aryeetey et al. 2014; Baah-Boateng 2013). A key indicator for measuring the extent to which macroeconomic growth results in gains in the welfare of the citizenry is the quality of jobs that the economy generates. Ghana’s employment growth lags behind economic growth, with an estimated employment elasticity of output of 0.47 (see Baah-Boateng 2013), suggesting that every 1 percent of annual economic growth yields 0.47 percent growth of total employment. Besides the slow rate of job creation is the dominance of vulnerable employment and the working poverty rate in the labor market. In 2010, 7 out of 10 jobs were estimated to be vulnerable while only 1 out of 5 jobs could be considered as productive jobs that meet the standard of decent work (Baah-Boateng and Ewusi 2013). Workers in vulnerable employment tend to lack formal work arrangements as well as elements associated with decent employment such as adequate social security and recourse to effective social dialogue mechanisms (Sparreboom and Baah-Boateng 2011). The working poverty rate remains a challenge with one out of every five persons employed belonging to poor households.

The article seeks to provide an analytical assessment of Ghana’s economic growth as one of Africa’s growth giants over a period of more than two decades and the implication for labour market and livelihood outcomes. Growth of labor productivity at the national and sectoral level is examined, as well as the sectoral contribution to aggregate productivity growth. The article also analyses the effect of growth on employment and the employment-poverty linkage in terms of elasticity within the growth-employment-poverty nexus in Ghana. It also delves into a discussion of the constraints on growth and productive employment from both demand and supply perspectives, and identifies skills gaps and the opportunities offered in the country, which has experienced strong growth performance. The article has five sections, with an overview of Ghana’s economic growth performance in Section 2, after this introductory section. This is followed by an overview of the developments in the labor market, specifically in the area of employment, unemployment, poverty, and inequality in Ghana in Section 3. The growth-employment-poverty linkage analysis is carried out in Section 4 followed by a discussion of constraints to growth and employment generation in Section 5. Section 6 provides a summary and conclusion, with some policy suggestions for the future.

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Over the past two decades, Ghana’s economy experienced an average annual growth rate of 5.8 percent, and became a low-middle income country in 2007. Though Ghana’s average annual employment growth between 1993 and 2013 has been higher than sub-Saharan Africa’s—3.7 percent versus 3.0 percent—its overall employment growth has not kept up with its economic growth. Notably, Ghana’s impressive economic growth has largely stemmed from crude oil exports, mining, and financial intermediation—all sectors and subsectors in which labor absorption is low. Given these trends, Ghana’s ability to transform its growth gains into better livelihoods for its citizens is being challenged.

In their paper, Understanding Ghana’s growth success story and job creation challenges, Ernest Aryeetey and William Baah-Boateng examine the sustainability of the high growth Ghana has experienced over the last two decades and advise Ghanaian policymakers to rethink their growth strategy.

For a more in-depth look at these and related topics, such as labor productivity, you can read the full paper here.

Like in many other sub-Saharan African countries, the agriculture sector is the largest employer in Ghana, though its employment share is decreasing from 61.1 percent in 1984 to 44.7 percent in 2013. In addition, while industry’s employment share has slightly grown from 13.7 percent to 14.6 percent over the same period (and the manufacturing subsector has decreased from 10.9 percent to 9.1 percent), services has grown from 25 percent to 40.9 percent—leading to what the authors refer as a “missing middle.”

As noted above, the authors emphasize that the sectors that have been driving Ghana’s growth are not labor-intensive, namely mining, oil extraction, and finance. While labor has been moving from agriculture to services, the authors note that the trend “may not reflect a structural and productive transformation,” largely because the jobs created in the services sector are mostly informal and have low productivity. Indeed, services sector maintained the lowest annual average growth of labor productivity between 1992 and 2013. As part of these shifts, informal employment—which represented 88 percent of Ghanaian employment in 2013—grew by 3.7 percent on average while formal employment grew by only 2.6 percent during this period.

Unemployment in Ghana remains low, at 5.2 percent, though has experienced significant swings from 2.8 percent in 1984 to 10.4 percent in 2000 to 3.1 percent in 2006. The authors note, though, that these numbers might be deceptive due to the high numbers of informal, vulnerable, and “discouraged workers” (those who are jobless and available for work but fail to make the effort to seek work for various reasons) in Ghana. In fact, they state that, in 2006, after accounting for discouraged workers the unemployment rate more than doubled from 3.1 percent to 6.5 percent.

Despite Ghana’s relatively low unemployment rate, many laborers still live in poverty: According to the authors, 22 percent of working people are poor. Many others work in “vulnerable employment”—which the authors define as “a measure of people employed under relatively precarious circumstances indicated by their status in employment. It consists of own account and contributing family work that are less likely to have formal work arrangements, access to benefit or social protection programs, and are more ‘at risk’ to economic cycles (ILO 2009).” This definition is opposed to “productive employment,” or “paid employment and self-employed with employees.” Vulnerable workers are usually found in the informal sector and tend to have lower earnings—a situation exacerbating the ever-widening earnings gap and growing income inequality.

According to the authors, working poverty is closely linked with vulnerable employment, for which seven of 10 jobs in Ghana qualify (Table 1).  Some policies, which could combat working poverty, have been somewhat ineffective in reducing poverty: For example, Ghana has been consistent in raising its minimum wage, keeping it largely above the rate of inflation, but this policy tends to only affect those in the formal sector, leaving out workers in the informal sector. This trend has also increased Ghana’s inequality: The Gini coefficient increased from 35.4 percent in 1987/88 to 42.3 percent in 2013.

Table 1: Quantity and quality of employment (percent of employed)

Notes: * Gainful/productive employment comprises paid employment and self-employed with employees.

** Vulnerable employment comprises own account and contribution family work.

Source: Computed from Ghana Living Standards Survey (GLSS) 3, 4, 5, and 6; Population Census 1984, 2000, and 2010.

Overall, though, Ghana has made great strides. Vulnerable employment has been declining, and productive employment has risen, gains the author attributes to the drop in working poverty—down from 48.7 percent in 1992 to 22.3 percent two decades later (Table 1). However, they also hint that these improvements could have been even larger had job growth been concentrated in paid employment and self-employed with employees.

In their paper, the authors posit that job creation has occurred in less productive sectors due to a lack of skills and education in the workforce—and skill-intensive jobs/vacancies are instead getting filled by foreign laborers. While the proportion of the labor force with no formal education has significantly fallen from 44.1 percent in 1992 to 25.6 percent in 2013, post-primary education rates have barely risen—from 5.7 percent to 12.1 percent during that same period for secondary, vocational, and technical education. Tertiary is even less—from 2 percent to 5.4 percent. Ghanaian universities have not been training engineers, scientists, and technical workers that could increase the productivity and grow the industrial sector. A shortage of technical and vocational skills also limits this sector. Thus, the authors note, employers are forced to look outside of the country to find the workers with the skills required to do the job. The authors emphasize:

[P]roductive structural economic transformation hinges on the level and quality of education and labour skills. A highly skilled, innovative, and knowledgeable workforce constitutes a key ingredient in the process of structural economic transformation, and as productive sectors apply more complex production technologies and research and development activities increase the demand for education and skills. However, the observed weak human capital base does not provide a strong foundation for structural economic transformation of Ghana.

At the same time, the more educated in Ghana also tend to be more likely to be unemployed due to limited job creation for them in the formal sector. In 2013, the unemployment rates for those with secondary education and above (including tertiary) was over 6 percent. The unemployment rate for those with basic education or less was under 3.3 percent. The authors suggest that this trend is due to the fact that those with less education are more likely to take an informal job, while more educated laborers struggle to find jobs in the small formal sector.

Though Ghana has outperformed many of its sub-Saharan neighbors in terms of job creation and growth, its challenges with declining manufacturing, high informal employment, and low education attainment endanger its momentum. To tackle these obstacles, the authors recommend:

1. Adjust the priorities of the growth strategy to promote manufacturing, and reconsider the goal of economic growth for growth’s sake by acknowledging that sustainable growth must be coupled with generation of productive and high-earning jobs for all.
2. Create a manufacturing and business-friendly environment by addressing the country’s high interest rates, high taxes, and chronic energy problems, among others.
3. Enact policies to enhance the high-productivity, high-labor-absorbing agricultural sector, such as improving agricultural extension, develop irrigation plans, among others.
4. Develop policies to increase the number of secondary school graduates as well as students studying science, technology, engineering, and math.

For further discussion and recommendations, read the full paper here.

Note: The African Lions project is a collaboration among United Nations University-World Institute for Development Economics Research (UNU-WIDER), the University of Cape Town’s Development Policy Research Unit (DPRU), and the Brookings Africa Growth Initiative, that provides an analytical basis for policy recommendations and value-added guidance to domestic policymakers in the fast-growing economies of Africa, as well as for the broader global community interested in the development of the region. The six papers, covering Mozambique, Kenya, Ghana, South Africa, Ethiopia, and Nigeria, explore the key constraints facing African economies as they attempt to maintain a long-run economic growth and development trajectory.

Issuing work permits to refugees in return for donor support for jobs is seen as a “win-win-win” for refugees, host countries, and the international community. It would stem the flow of refugees to Europe, decrease the dangers of radicalization, and prevent the exploitation of refugees as a source of cheap labor. At last February’s “Supporting Syria and the Region” conference co-hosted by the U.K., Germany, Kuwait, Norway, and the United Nations, former British Foreign Secretary David Miliband called for a million work permits to be made available to Syrians, 200,000 each in Jordan and Lebanon and 600,000 in Turkey.

Turkey issued a decree in January 2016 allowing work permits for Syrians. Jordan also agreed to provide work permits for up to 200,000 Syrians over a number of years in exchange for aid and the opening of European markets to goods produced or special economic zones—all this to lead to jobs for one million Jordanians as well when other aid and spending is added in. Lebanon, whose fragile confessional politics makes the one million plus Sunni refugees a more palpable threat, has chosen not to issue work permits. Yet, according to the International Labor Organization (ILO), “around half of (working age) Syrian refugees are economically active and just one-third have access to overwhelmingly informal and low-skilled employment.” That’s around 165, 000 employed informally. The number is around 160,000 in Jordan  with 1.3 million Syrians and over 400,000 in Turkey with 2.7 million Syrian refugees.  

In Turkey and Jordan, as elsewhere, work permits are tied to employers who apply on behalf of employees once residency, registration, and health requirements are met. In both countries, employers must pay the legal minimum wage and social security payments. The permits are renewed annually. But, for the majority of Syrians working in labor markets with an abundance of local and foreign low-skill, low-wage workers, the pay is nowhere near the minimum wage. As to the promised jobs in the special zones, those will take time to materialize, and we already know that, at least in the garment sector, up to 80 percent of the workers are young women from South Asia, largely residing in dorms but at least receiving the minimum wage. Whether Syrians can adapt to this model remains to be seen. In both Jordan and Turkey, there are certain limits on the percentage of Syrians versus locals in many manufacturing and services jobs; in Jordan there is some evidence that “ghost” Jordanian workers are used to get around this requirement.

Jordan already has over 240,000 foreign workers, mainly Egyptians and Asians, who have work permits, with the total number including those working illegally may be as high as a million. There is a move to get Syrians to replace the foreign workers with permits but that seems a bit uncertain. It seems unlikely that employers will be eager to replace employees, often of long standing and for whom they have gone to the expense of getting work permits.  In Turkey, with fewer foreign workers, many locals work informally, though they tend to get paid significantly more than Syrians. The chances of employers hiking up wages to legalize Syrian employees, whether in Jordan or Turkey, are slim and the record to date appears to confirm this.   

In Jordan, the government provided a three-month grace period for workers to receive permits free of charge. Less than 2,000 permits had been granted by April. An ILO survey in Jordan, which looked at workers in the construction and agriculture sectors, noted that while 90 percent of workers had heard about the grace period, none in the agriculture sector and only 85 percent in construction had work permits, though almost all knew that getting caught might mean detention at the Azraq refugee camp. And an inability to pay social security constituted a major barrier. Often a concern is to go through employers to get the permit.  

In Turkey, the numbers are not encouraging either: By May, only 10,000 had actually registered for work permits. Refugees International reports that Turkey’s work permit program may end up benefitting 40,000 Syrians or roughly 10 percent of those actually working. The government, though, thinks that the program will eventually help all those currently working informally.

The ILO, United Nations High Commissioner for Refugees, and Refugees’ International have praised the Jordanian and Turkish governments for granting work permits. The decision was not easy and was politically charged in both countries. But the political and psychological significance of providing an opening for Syrians to slowly integrate themselves and move towards a stable future is certainly worth pursuing, even if it doesn’t bring immediate rewards. Already, Turkey allows Syrian doctors and medical personnel to work in health centers serving refugees. Over 4000 Syrian teachers have received stipends from a Ministry of Education program funded by UNICEF and western donors. And agricultural workers no longer need work permits so long as provincial governors give their approval.

Eventually delinking work permits from employers will help, and the ILO urges Jordan to do so for agricultural and construction workers. In both Jordan and Turkey, lowering social security payments would also smooth the transition. More support to vocational training, health care, education for children are other ideas being pursued. While making work permits available is not the same as a blanket “right-to-work” law for refugees, a right protected under the U.N. 1951 Refugee Convention but accepted in full neither by Jordan nor Turkey (however, the key international treaty that protects the right to work in binding form is the International Covenant on Economic, Social and Cultural Rights to which Jordan and Turkey are signatories), this is an opening and one that the international community should monitor and support. Aside from the February conference, other agreements—such as the one between the EU and Turkey and the upcoming EU deal with Lebanon and Jordan—provide suitable platforms towards improving on this initial phase.   

On Monday, the White House Council of Economic Advisers (CEA) released a report examining the long-term decline in the share of prime-age men (aged 25 to 54) who are either working or actively looking for work. What economists call the labor force participation rate for this population decreased from 98 percent in 1954 to 88 percent today, the second largest decrease among OECD countries. This trend has raised concerns not only for its impact on economic growth, but also because it seems to track an increase in mortality over that time, particularly among white males, as economists Anne Case and Angus Deaton have found.

The CEA report documents a number of possible explanations for this trend, including increasing rates of women in the workforce, rising disability insurance claims, falling demand for less-skilled workers, and barriers to employment for those with criminal records.

The report’s national analysis alone, however, obscures tremendous variation across the United States in employment among this critical group.

According to data from the Census Bureau’s American Community Survey, in 2014, 81 percent of prime-age men nationwide were employed (this statistic differs from the labor force participation rate in that it omits those who are looking for, but not in, work). Yet among the nation’s 374 metropolitan areas for which data are available, that rate ranged from over 93 percent in the oil boomtown of Midland, TX, to just over 50 percent in Kings County in California’s Central Valley.

There are clear regional patterns to this important statistic. Many of the metro areas with the highest employment rates for prime-age men are smaller places located in the middle of the country, from the Upper Midwest, to energy-rich areas in Texas and the Plains states, to the Intermountain West. In several large, economically dynamic metro areas such as Denver, Houston, Minneapolis, San Jose, and Washington, D.C., rates of work among prime-age men are also very high.

Of much greater concern is the large number of metropolitan regions with very low rates of work among prime-age men. These include many small former industrial centers in states like Michigan, Indiana, and Ohio; areas of West Virginia and Louisiana that rely on declining-employment industries like mining; and long-struggling agricultural economies in Arkansas, Texas, and inland California.

These patterns echo findings from the CEA report that falling demand for labor is an important part of the long-term decline in prime-age male employment. In many places where a high school diploma alone once provided the gateway to a middle-class job, nearly one-third of men in this age group are out of work. This is also evident in the local relationship between educational attainment and work—where educational attainment rates are higher among prime-age men, members of that group are more likely to be employed. A 10-percentage point difference in employment rates separates the most highly-educated quarter of metro areas from the least highly-educated quarter.

Beyond education, size seems to matter, too. Large metro areas exhibit higher rates of work among prime-age men than small metro areas. Across the 100 largest U.S. metro areas, 83.2 percent of prime-age males are employed, compared to 79.8 percent in the smaller 274 metro areas. This relationship partly reflects that men in large metro areas have higher rates of educational attainment than those in small metro areas. Yet even men who have no more than a high-school diploma work at higher rates in large metro areas (64 percent) than similarly educated men in smaller metro areas (62 percent). Larger regional economies with greater economic diversity may stimulate stronger demand for workers at lower skill levels.

Several of the policies that the CEA report recommends to improve prime-age male labor force participation, such as bolstering investment in public infrastructure, reforming unemployment insurance, and boosting educational attainment could help boost rates of work in lagging U.S. metro areas. However, none directly addresses the fact that problems in male employment disproportionately affect small and often economically isolated U.S. regions. This evidence suggests that policies to help dislocated workers relocate to larger, more economically dynamic metro areas—particularly by improving the supply of affordable housing in those regions—should be part of a comprehensive strategy to help reverse the troubling long-term decline in men’s work.

In a recent analysis, I highlighted how employment and disconnection among young people vary by age, race, and place. In this podcast, I dig deeper into the data on the Washington, D.C. region. Although the area generally performs well on employment measures, not all young people are faring equally well.

Listen to the full podcast segment here: 

Event Information

Sub-Saharan Africa’s growth performance over the last decade has been astounding, though they mask underlying job creation challenges facing policymakers. The unemployment rate for sub-Saharan Africa remained fairly stable over the period. In 2015, it stood at a slightly high 7.4 percent, compared with over 9 percent in the European Union and 5.3 percent in the United States. However, the figures on vulnerable employment and the working poor[1] in Africa tell a different story—averaging 69.9 percent and 64.0 percent in 2015, respectively. Indeed, of those who are employed, four in five workers are not in the wage economy, but in the informal sector, with no access to workers’ benefits, social protection, and job reliability. In addition, many workers—both formal and informal—are underemployed or overqualified.

The conventional knowledge of structural transformation—labor migration from agriculture to high-productivity, labor-intensive industry—has been turned on its head in Africa. Instead, Africans are moving to jobs in the services sector, which some experts argue is a less productive path. Then again, unique opportunities in African digital jobs are opening up doors the world has never seen before.

The need for decent job creation in Africa also provides both threats and opportunities to the United States. For example, a lack of viable jobs could make the turn to crime, violence, and even extremism—with the promise of steady income from these activities—more appealing to economically marginalized individuals, especially among the youth. Furthermore, job creation boosts the growth of the middle class, expanding the base of consumers for American products, at the same time creating new, stronger trade partners able to supply goods to American consumers. Already, the United States and other countries are creating a myriad of programs to boost entrepreneurship on the continent.

On Monday, June 27, the Brookings Institution’s Africa Growth Initiative and the Congressional African Staff Association hosted an event to discuss why Africa is struggling to create the quantity and quality of jobs it needs and what policies—both African and U.S.—can turn that trend around. Ernest Danjuma Enebi, founder and managing partner of The Denda Group, moderated the discussion. Panelists included Dr. Eyerusalem Siba, research fellow at the Africa Growth Initiative; Hassanatu Blake, co-founding director and president of the non-profit Focal Point Global; and Nicolas Cook, a specialist in African Affairs in the Foreign Affairs, Defense, and Trade Division of the Congressional Research Service.

The discussion touched on multiple key points, including what Africa’s unique structural transformation path means for the region’s employment landscape; how development partner efforts affect job growth on the continent; how Africa can avoid a potential “demographic timebomb” of youth unemployment and instead benefit from a “demographic dividend”; and how the United States is addressing the challenges these trends pose for both the continent and the U.S.

Enebi began the dialogue with a Q&A with Siba on an overview of African economic trends, youth unemployment, and formal sector jobs on the continent.

Blake argued that the high youth unemployment is due in part to the region’s struggling educational systems where Poor quality education leads to poor grades on periodic tests and thus students are being pushed out of school, she said. Once out of the formal schooling system, they enter the workforce underprepared without the skills they need to succeed in the job market.

Blake continued to argue this point through a description of Harambee, a private South African organization that works towards improving prospects of youth employment. The program has placed over 20,000 youth into jobs over the past 5 years by testing job applicants on literacy and mathematical ability and matching them with employers. Harambee addresses a broader skills mismatch that Blake argued is holding back job creation. More broadly, Blake argued, public-private partnerships must be created to help youth find jobs and employers find employees.

A major theme of the discussion was that a shift away from aid and towards the support of labor-intensive industries and enabling environments for business can spur job creation.

Of course, causes of unemployment are largely driven by the demand-side factors, acknowledged the panelists. A major theme of the discussion was that a shift away from aid and towards the support of labor-intensive industries and enabling environments for business can spur job creation. Indeed, Cook discussed the importance of the mantra “trade not aid” in addressing these issues, as there are many large American firms with an economic interest in expanding to Africa; however this interest is miniscule compared to Africa’s trade with the rest of the world. Increasing global investments in Africa is, thus, a key part of any job creation, he emphasized.

Cook also touched on global relationships with Africa. He noted that only 1 percent of U.S. foreign direct investment (FDI) goes to Africa, and only one percent of American trade is with Africa. Now, several economic development programs, like the U.S. Electrify Africa Act of 2015 and the USAID Power Africa Initiative, exist but are in need of continued funding. To boost trade, the United States has launched the Trade Africa program and has established trade hubs in western, eastern, and southern Africa.

Investments in infrastructure, greater participation in the export market, interventions on improving managerial and marketing skills and the use of information and communications technologies (ICTs) to access global markets can help clear the way for greater job creation.

Siba agreed with the idea of a focus on trade and FDI as major factors in job creation. In fact, she shifted the discussion toward a focus on investments in supporting industry because, as she emphasized, the biggest predictor of business performance including job creation is export market participation. Investments in infrastructure, greater participation in the export market, interventions on improving managerial and marketing skills and the use of information and communications technologies (ICTs) to access global markets can help clear the way for greater job creation, she said.

There are clearly many opportunities for foreign investors to support African industry, but challenges to development remain due to poor infrastructure and a lackluster environment for business.

Blake agreed that ICTs and infrastructure hold great potential for spurring job growth, but pointed out that ICT and infrastructure investment “look different” in different parts of the continent. In some countries in central Africa that she worked with and Cameroon, she suggested, ICTs are not always the best vehicle to drive job growth due to the prohibitive cost of ICT devices and emphasized that keeping local conditions in mind when exploring potential job-creating programs and investments is essential for success.

Cook then pivoted to a discussion on the importance of small enterprises and technology in boosting job growth. He pointed out the importance of WhatsApp as a new means of communication that has helped spur job growth and productivity, and the mobile money transfer platform m-Pesa as a key component of the increase in micro-lending in Kenya. Offered by Safaricom, Kenya’s largest mobile network, M-Pesa allows mobile phone users to transfer money, pay bills, and deposit money. The World Bank highlighted the service in 2009, concluding that “The affordability of the service has been key in opening the door to formal financial services for Kenya’s poor.” The service has also allowed financing of micro-enterprise to take off, but Cook acknowledged that ascertaining the precise impact of these technologies on job growth is very difficult due to the scarcity of data.

The small credit card market and rarely used banking services exclude a wide percentage of the population from the financial system. The widespread presence of mobile phones has now opened up this system.

Fifty to 80 percent of new jobs in Africa are created by small businesses that are not likely to survive more than five years.

Siba elaborated on Cook’s description of the vital role of small businesses in creating jobs on the continent. She argued that any job creation programs in Africa should focus on solving the challenges of small businesses in job creation because they dominate the market structure. Unfortunately, at the moment, small businesses there are not robust. Fifty to 80 percent of new jobs in Africa are created by small businesses that are not likely to survive more than five years. Since small and medium enterprises comprise over 90 percent of all firms in sub-Saharan Africa, this volatility affects the whole economy. As a result, any potential solutions must take this market structure into account. In addition, as Siba suggested, increased focus must be paid to the integration of African businesses into regional markets and domestic and global value chains so that small and medium enterprises have more opportunities to grow.

The discussion concluded with a focus on opportunities for growth: Governments should focus on processing raw commodities for local uses, like timber, coffee, and cocoa; small- and medium-sized enterprises should be scaled up with stronger access to financing and skill development; governments should pursue partnerships with private companies to address the skills mismatch; and education funding should be deliberately targeted to address missing skills, correctly processed, and carefully monitored. Continued job creation in Africa depends on it.

June’s jobs gains, released this morning, show that 287,000 new jobs were added in June, an impressive rebound after only 11,000 new jobs were added in May (revised down from from 38,000 at the time of the release).

This year’s monthly job gains and losses can indicate how the economy is doing once they are corrected to account for the pattern we already expect in a process called seasonal adjustment. The approach for this seasonal adjustment that is presently used by the Bureau of Labor Statistics (BLS) puts very heavy weight on the current and last two years of data in assessing what are the typical patterns for each month.

In my paper “Unseasonal Seasonals?” I argue that a longer window should be used to estimate seasonal effects. I found that using a different seasonal filter, known as the 3x9 filter, produces better results and more accurate forecasts by emphasizing more years of data. The 3x9 filter spreads weight over the most recent six years in estimating seasonal patterns, which makes them more stable over time than in the current BLS seasonal adjustment method.

I calculate the month-over-month change in total nonfarm payrolls, seasonally adjusted by the 3x9 filter, for the most recent month. The corresponding data as published by the BLS are shown for comparison purposes. According to the alternative seasonal adjustment, the economy added 286,000 jobs in June (column Wright SA), almost identical to the official BLS total of 287,000 (column BLS Official).

Data updates released today for prior months also reveal some differences between my figure and the official jobs gains from prior months. The official BLS numbers for May were revised down from 38,000 new jobs to a dismal 11,000. My alternative adjustment shows that the economy actually lost 6,000 jobs in May, down from 17,000 jobs gained at the time of the release. [i] The discrepancies between the two series are explained in my paper.

In addition to seasonal effects, abnormal weather can also affect month-to-month fluctuations in job growth. In my paper “Weather-Adjusting Economic Data” I and my coauthor Michael Boldin implement a statistical methodology for adjusting employment data for the effects of deviations in weather from seasonal norms. This is distinct from seasonal adjustment, which only controls for the normal variation in weather across the year. We use several indicators of weather, including temperature and snowfall.

We calculate that weather in June brought up the total by 25,000 jobs (column Weather Effect), but this should be considered a transient effect. Our weather-adjusted total, therefore, is 262,000 jobs added for June (column Boldin-Wright SWA). This is not surprising, given that weather in June was in line with seasonal norms.

It’s good to see the jobs numbers rebounding this month. The May number was somewhat affected by the Verizon strike. Also, it is important to remember that pure sampling error in any one month’s data is large, and that could explain part of the weak employment report for May. Averaging over the last three months, employment is expanding by about 150,000 jobs per month—a healthy pace, although a bit of a step down from last year.

a. Applies a longer window estimate of seasonal effects (see Wright 2013). The June 2015 to May 2016 values in this column have been corrected to remove a coding error that affected the previously reported values.

b. Includes seasonal and weather adjustments, where seasonal adjustments are estimated using the BLS window specifications (see Boldin & Wright 2015). The incremental weather effect in the last column is the BLS official number less the SWA number.

[i] Note that, due to a small coding error, my alternative seasonal adjustment for May, at the time of the release, should have been 17,000 new jobs, not -4,000, as was reported in my previous post. In addition to the underlying data revisions, and correcting for this error, the revised alternative seasonal adjustment for May is -6,000 jobs added (second row of column Wright SA).

On Monday, July 18, 2016, the world celebrated Nelson Mandela International Day, a day recognizing the former president of South Africa’s commitment to fostering peace and freedom. Every year the Nelson Mandela Foundation hosts a lecture, inviting prominent individuals to discuss significant social issues affecting the African continent. For this year’s lecture, Bill Gates was selected to speak on the theme of “Living Together” in front of a packed stadium in Pretoria. Gates focused on a topic Mandela returned to repeatedly throughout his life—the power of the youth. In the words of Gates, “…young people are better than old at driving innovation because they are not locked in by the limits of the past… we must clear away the obstacles standing in young people’s way so that they can seize all of their potential.”

Unfortunately, South Africa, the second-largest economy on the continent, has the highest youth unemployment rate at 54 percent, as seen in the figure below. Surprisingly, according to the figure the highest rates of youth unemployment lie in the upper-middle-income countries as classified by GNI per capita. Additionally, these unemployment rates might be depressed due to the fact that unemployment refers to people looking for jobs, and many of Africa’s youth are forced into the informal sector after giving up on their search for employment.

Although youth unemployment in Africa is often seen as a growing challenge, a number of experts interpret the large youth population as an opportunity, as long as the youth have access to the economic opportunities through which they can channel their energy into progress. As Africa’s youth is predicted to grow exponentially, achieving broad-based economic growth and development will rely on breaking down the barriers to economic opportunity, by investing in human capital (through education) and in improving business environments. 

Figure 2.3. Youth unemployment will continue to be a growing challenge in 2016

Interestingly, GDP and income classification have little correlation with youth unemployment rates. For example, South Africa, which has the second-largest economy on the continent and is considered an upper-middle-income country based on its GNI per capita, has the highest youth unemployment rate at nearly 54 percent. Meanwhile, the Liberian economy, which is nearly 200 times smaller than South Africa’s, has a youth unemployment rate 10 times smaller. Youth unemployment is measured as the share of the labor force (ages 15-24) without work but available for and seeking employment. Estimates may be low in some low-income countries like Liberia because many young people cannot afford not to work to seek employment and as a result, end up in low-paying jobs.

Source: Youth unemployment figures from World Development Indicators and GDP data from the World Bank databank.

See the Brookings Africa Growth Initiative’s Foresight Africa 2016 report, from which the figure below comes, for more highlights on the growing challenge of youth unemployment in Africa. In addition, earlier this month the Brookings Institution hosted an Africa Policy Dialogue on the Hill on jobs in Africa, alluding to the shortcomings of the educational systems and the importance of infrastructure and electricity to support business and attract investment. For a summary of the conversation, see here.

Tor Syvrud contributed to this post.

Unlike prime-age Americans, who have experienced declines in employment and labor force participation since the onset of the Great Recession, Americans past 60 have seen their employment and labor force participation rates increase.

In order to understand the contrasting labor force developments among the old, on the one hand, and the prime-aged, on the other, this paper develops and analyzes a new data file containing information on monthly labor force changes of adults interviewed in the Current Population Survey (CPS).

The paper documents notable differences among age groups with respect to the changes in labor force transition rates that have occurred over the past two decades. What is crucial for understanding the surprising strength of old-age labor force participation and employment are changes in labor force transition probabilities within and across age groups. The paper identifies several shifts that help account for the increase in old-age employment and labor force participation:

• Like workers in all age groups, workers in older groups saw a surge in monthly transitions from employment to unemployment in the Great Recession.
• Unlike workers in prime-age and younger groups, however, older workers also saw a sizeable decline in exits to nonparticipation during and after the recession. While the surge in exits from employment to unemployment tended to reduce the employment rates of all age groups, the drop in employment exits to nonparticipation among the aged tended to hold up labor force participation rates and employment rates among the elderly compared with the nonelderly. Among the elderly, but not the nonelderly, the exit rate from employment into nonparticipation fell more than the exit rate from employment into unemployment increased.
• The Great Recession and slow recovery from that recession made it harder for the unemployed to transition into employment. Exit rates from unemployment into employment fell sharply in all age groups, old and young.
• In contrast to unemployed workers in younger age groups, the unemployed in the oldest age groups also saw a drop in their exits to nonparticipation. Compared with the nonaged, this tended to help maintain the labor force participation rates of the old.
• Flows from out-of-the-labor-force status into employment have declined for most age groups, but they have declined the least or have actually increased modestly among older nonparticipants.

Some of the favorable trends seen in older age groups are likely to be explained, in part, by the substantial improvement in older Americans’ educational attainment. Better educated older people tend to have lower monthly flows from employment into unemployment and nonparticipation, and they have higher monthly flows from nonparticipant status into employment compared with less educated workers.

The policy implications of the paper are:

• A serious recession inflicts severe and immediate harm on workers and potential workers in all age groups, in the form of layoffs and depressed prospects for finding work.
• Unlike younger age groups, however, workers in older groups have high rates of voluntary exit from employment and the workforce, even when labor markets are strong. Consequently, reduced rates of voluntary exit from employment and the labor force can have an outsize impact on their employment and participation rates.
• The aged, as a whole, can therefore experience rising employment and participation rates even as a minority of aged workers suffer severe harm as a result of permanent job loss at an unexpectedly early age and exceptional difficulty finding a new job.
• Between 2001 and 2015, the old-age employment and participation rates rose, apparently signaling that older workers did not suffer severe harm in the Great Recession.
• Analysis of the gross flow data suggests, however, that the apparent improvements were the combined result of continued declines in age-specific voluntary exit rates, mostly from the ranks of the employed, and worsening reemployment rates among the unemployed. The older workers who suffered involuntary layoffs were more numerous than before the Great Recession, and they found it much harder to get reemployed than laid off workers in years before 2008. The turnover data show that it has proved much harder for these workers to recover from the loss of their late-career job loss.

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