Greetings from Davos, Switzerland. I’m here this week to talk about what governments and the private sector can do to tackle the world’s biggest health challenges.
Yesterday, I attended the launch of the Coalition for Epidemic Preparedness Innovations (CEPI), a global initiative designed to accelerate the development of vaccines for emerging infectious diseases with the aim of preventing future pandemics. Here’s a fascinating interactive visualization that we produced to explain what CEPI is and why we need to take action now against a host of emerging infectious diseases.
But we also need to stay focused on existing epidemics. While the Ebola outbreak of 2014–15 and the Zika outbreak of 2016 have raised justifiable alarm, HIV, tuberculosis and malaria remain massive public health emergencies that claim millions of lives each year. One of the best ways to fight these diseases is to ensure that we make new tools designed to fight them available to the people who need them as quickly as possible. And so I also have been meeting in Davos with colleagues from sub-Saharan Africa to discuss how we can accelerate the discovery, development, and regulatory licensing of a range of life-saving interventions.
Innovation transforms lives. From the light bulb to penicillin to the personal computer, clever ideas turned into real products through painstaking research and development have radically changed the way we live. Innovative breakthroughs have also led to a major shift in how long we live. Vaccines, drugs and other medical technologies eradicated smallpox, turned diabetes and HIV from death sentences into a manageable conditions, and have made us healthier in countless other ways.
But good ideas and powerful products can’t change lives if people can’t access them. Many roadblocks keep lifesaving innovations out of reach for the people who need them most. Perhaps the most frequently debated are the cost of medicines and challenges in delivering them to remote communities. Less prominent is the preliminary milestone in making health products accessible: regulatory approval.
Particularly in low- and middle-income countries, regulatory systems designed to protect against harmful or ineffective products are so complex that medicines or vaccines can languish within them for years. In poor countries where the burden of deadly and debilitating diseases is already unacceptably high, regulatory delays — while seemingly technical and bureaucratic — can be devastating. Babies who would reach primary school in other parts of the world die from preventable diseases while waiting for vaccines already available in richer countries; drugs that return patients to health in one country remain inaccessible just across the border.
New research from my colleagues at the Bill & Melinda Gates Foundation helps explain why the introduction of new medicines or vaccines in poor countries lags, on average, four to seven years behind the initial regulatory application in rich ones. Typically, once a product is registered in the country where it’s made, the World Health Organization (WHO) performs a review to confirm that it is a high-quality product and will be safe and effective in low- and middle-income countries. Then, the product must be registered in each country that intends to distribute it. Unfortunately, these different authorities sometimes undertake similar scientific tests and visits to manufacturing facilities, so a process that should only take a few months can stretch into years.
In comparison, most high-income countries require a single regulatory approval to introduce new products, since regulators like the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) use uniform scientific and technical standards. For example, a drug used to treat HIV received regulatory approval in the US after just six months; seven years later, some countries in sub-Saharan Africa were still waiting for local registration.
Of course, simplifying medical product registration is not easy. It will require cooperation from national governments, cross-national bodies like the WHO, and product developers and manufacturers to overcome resource challenges and streamline lengthy and complex processes.
First, regulatory authorities can work together to reduce duplicative efforts. The extensive assessments of drug quality and manufacturing facilities that well-resourced authorities like the FDA and EMA conduct can be shared with the WHO and national authorities in countries with fewer resources. This would significantly reduce approval time and allow national authorities to devote resources to activities that add unique value, such as pharmacovigilance to monitor the quality and safety of drugs and vaccines once they reach the market. This sharing of quality and safety information is already happening at the WHO and in specific countries, but can be further expanded.
Low- and middle-income countries can also collaborate to simplify regional regulatory standards, which encourages manufacturer applications, reduces application errors and therefore speeds the introduction of new products. A pilot project by the African Medicines Regulatory Harmonization (AMRH) initiative, which works to integrate registration processes for medical products among countries in regional economic communities, reduced drug approval time in the East African Community by more than 50%. Expanding this initiative could dramatically improve access to medical products in some of the poorest countries in the world.
I’m thrilled to see countries, the WHO and AMRH partners working to harmonize complex regulatory systems across borders. Drug manufacturers that benefit from streamlined processes should in turn commit to timely and sufficiently resourced registration of products in all countries, rich or poor. Submitting complete applications, engaging regulatory bodies early and responding promptly to follow-up can eliminate months of delay and ensure that lifesaving products reach those most in need.
Collective action can guarantee that breakthrough innovations rapidly deliver impact. We saw this with the introduction of the meningitis A vaccine in sub-Saharan Africa. Thanks to coordination between the WHO and national authorities, MenAfriVac, the first vaccine tailor-made for Africa, was introduced in multiple countries within a year of its initial regulatory registration. The results are stunning: meningitis cases have dropped by more than 90 percent in areas where use of the vaccine is widespread.
Developing products with the power to transform the health and lives of millions of people can take years — if not decades. Providing access to proven products should not extend the wait. Safely optimizing the regulatory landscape to make medicines and vaccines available more quickly in all countries can save lives.