hould each East Africa Community (EAC) partner state have an autonomous medicine regulatory agency while the region promotes regulatory harmonization and reliance? Do we need both? Given constrained government budgets, we are often faced with this question. Should countries that do not already have one, establish one? Should those countries that already have one reconsider its place and role?

Why Do Nations Need to Regulate Medicines?

Medicines are not ordinary consumer goods, and therefore consumers may not be able to determine if a medicine is safe, efficacious, and of quality. Safety relates to weighing the known benefits of using the medicine against the known risks. Efficacy refers to the ability of the medicine to produce the desired beneficial effect claimed on the medicine label by the manufacturer, when used as labeled in the intended population.

Quality of a medicine is a manufacturing concept that addresses the consistency of the manufacturing process to ensure that medicines meet international standards in terms of strength, purity, packaging, and labeling. It would be hugely problematic for example, if the same pill you take today were to have a different quantity of the active substance/ingredient (e.g., 10 mg) from the one you take tomorrow (perhaps 18 mg) when both claim to contain 10 mg, or it had a different active ingredient or no active ingredient at all. The concept and means of assuring quality has evolved over time. However, even healthcare professionals (medical doctors, pharmacists) may not have the capacity to make informed decisions about all aspects of medicines without special training and access to information about how the medicine was manufactured.

What is the Mandate of a Medicine Regulatory Authority or Agency?

National regulatory agencies (NRAs) protect and promote public health by ensuring that medical products such as medicines, vaccines, and medical devices are safe, of quality, and are efficacious. Their role is codified in national legislation and put into practice by applying a set of internationally recommended core regulatory functions. According to the World Health Organization (WHO), NRAs contribute to promoting and protecting public health by ensuring that:

• medicines are of the required quality, safety and efficacy;
• health professionals and patients have the necessary information to enable them to use medicines rationally;
• medicines are appropriately manufactured, stored, distributed and dispensed;
• illegal manufacturing and trade are detected and adequately sanctioned;
• promotion and advertising is fair, balanced, and aimed at rational drug use and;
• access to medicines is not hindered by unjustified regulatory work.

Autonomous agencies are government entities given a mandate by law to exercise independence in decision-making over medicine regulation and will usually report to a Board rather than directly to another Government department. A recent survey by the WHO shows that only 40 percent of countries in the WHO Africa Region have an autonomous or semi-autonomous agency. The EAC is doing a lot better with five of the six member states with an autonomous or semi-autonomous agency. The Rwanda Food and Drugs Authority was established this year, while in March 2018, the National Legislative Assembly of Burundi reviewed and considered legislation establishing the Autorité Burundaise de Regulation des Medicaments et des Aliments (ABREMA) that is waiting to be gazetted into law.

The capacity of NRAs to effectively undertake their functions varies widely. The WHO categorizes regulatory agencies into maturity levels from 1 through 4 with 4 being the highest ranking. High-income countries are generally better able to staff and finance regulatory authorities in terms of expertise, numbers, and facilities required for their work. Even with resource constraints, however, low-income country regulators can achieve a high standard of performance through reliance on work done by others when making their own regulatory decisions, and sharing work with other agencies to extract the most value from the resources at their disposal.

EAC Regulatory Harmonization Initiative: Goals, Accomplishments, the Work Ahead

The East African Community Medicines Regulatory Harmonization initiative (EAC MRH) was launched in 2012 to harmonize the technical requirements and processes needed in the regulation of medical products in the EAC Partner States, to increase the availability of high-quality, safe, and efficacious essential medicines within this region. The initiative sought to remove duplication, to harmonize disparate requirements among countries, to promote efficiencies, to enable work-sharing, to build capacity, and to reduce the time it takes for products to be authorized in the EAC without compromising product quality, efficacy, and safety.

The EAC MRH is part of the larger African Medicines Regulatory Harmonization (AMRH) initiative launched in 2009 by the AU NEPAD Agency and various partners; the EAC was the first African Regional Economic Community (REC) to implement this initiative.

Over the last five years, the EAC MRH has led to a much more harmonized system of product dossier submission and review across the EAC. All countries now use the same marketing authorization requirements and standards as well as the same assessment tools. In addition, joint assessment of dossiers is well underway with more than 60 applications submitted and eleven products registered at the country level based on a positive recommendation at their regional joint assessment.

These joint assessments provide a platform for the region to pool expertise and undertake high-quality assessments that might not be possible in each individual country and undertake review of complex products for which there is limited expertise in the region. This systems optimization introduces efficiencies and costs savings that will ultimately accrue to the healthcare system, taxpayer, and patient.

While the EAC MRH initiative initially focused on generic medicines, it is now looking to expand its scope to other product classes (new chemical entities, vaccines, diagnostics) and other regulatory functions (safety surveillance, clinical trials authorization and oversight) as a result of its progress. The goal of this initiative is to assure that only safe, efficacious, and quality medicines can enter the EAC market.

Looking to the future, a regional technical cooperation agreement that will underpin these developments and establish the policy and legal basis for cooperation was recently endorsed by the Council of Health Ministers.

Second, the heads of agencies from the Partner States have together agreed with the EAC Secretariat to set up a small group of dedicated national technical staff to lead the technical aspects of the joint activities with close oversight from a regional forum of the heads of agencies. This small group will work closely with the EAC Secretariat in delivering on its mandate. We expect that this will go a long way in optimizing regional processes and accelerating access to lifesaving quality medicines. The heads of agencies also agreed to explore avenues for financing regional joint activities, including charging a premium fee to industry applicants, which is strongly linked to a transparent and predictable regional mechanism.

Third, the EAC MRH program will continue to build value-added capacities of all national agencies so that they can all effectively participate in and contribute to regional joint activities.

Given these developments, and the ability of countries to eventually rely on a regional regulatory mechanism, why should each country continue to maintain its own autonomous agency or authority?

What is the Value of an Autonomous Agency?

While the EAC MRH program promotes reliance and work-sharing amongst the EAC Partner States as well as reliance on better resourced regulators, including the WHO’s prequalification program, there are functions/activities that each country must undertake on its own, and that no other country or agency can do for another. These functions require a strong, autonomous, but right-sized agency so that access to medicines is not hindered by unjustified regulatory work.

Functions that must be undertaken by a regulatory authority within each country include the following:

1. Maintaining a comprehensive register of medicines authorized (judged to be safe, efficacious, and of good quality) to circulate in the country. This register is the first place of call to determine if any product on the market is genuine or a counterfeit.
2. Based on the national register of authorized medicines, and access to quality control laboratory capacities (each country does not need to have its own), regulators can then surveil, detect, and remove from the market any counterfeit medical products.
3. Where there is local manufacturing, provide regulatory oversight to ensure that manufactured products are safe, efficacious, and of good quality.
4. Regulation and oversight of clinical trials for investigational new drugs (INDs) within their jurisdiction.
5. Ensure that healthcare professionals and patients have the necessary information to enable them use medicines rationally.
6. Ensure medicines are appropriately stored, distributed, and dispensed.
7. Contribute expertise to “networked” regional activities, which are fully dependent on experts drawn from countries in the network.
8. Monitoring the safety of marketed medicines including collecting and analyzing adverse event reports.

Why do these agencies need autonomy? First, autonomy guarantees a level of independence (from undue influence) for the agency to make decisions on product quality, safety, and efficacy on the basis of science and public health, and nothing else. And, second, without an autonomous agency, it is difficult to provide the regulatory oversight necessary to assure that medical products produced locally are of quality for both local and external markets. External markets will be particularly reluctant to buy products from markets in which the regulator’s competency and independence are in doubt. Therefore, by maintaining high regulatory standards, NRAs allow their national manufacturers to participate in global commerce, as well as WHO’s prequalification program, improving global supplies for the benefit of those most in need. In this way, a highly performing regulatory agency is a promoter of both economic health and public health.

Third, an autonomous agency is able to generate its own revenue through fees for service that allow it to hire and retain competent staff. Without these agencies, nations stand the risk of failing in their duty to protect their citizens’ public health, as well as their national security, by allowing the illegal manufacturing and trade of drugs to go undetected.