Why we need strong regulatory systems to reach universal health coverage
1 July 2019 - In recent months regulators across many countries have recalled dozens of medicines to treat high blood pressure because they were found to contain potentially cancer-causing impurities.
These medicines (including valsartan, losartan, Irbesartan) are commonly prescribed globally and came from different manufacturers. The impurities were due to changes in the manufacturing process.
A little less recently, in 2014, in the Ituri district of the Democratic Republic of the Congo, several people, 60% of them children, became sick after taking a medicine believed to reduce shivering and fevers from malaria. It turned out the medicine contained haloperidol, an antipsychotic substance used to treat schizophrenia. Investigators found that the tablets people had been taking contained 13 mg of the drug, about 20 times the maximum recommended dose for a child. By the time the source of the problem was identified, 930 people had been hospitalized and 11 had died.
 WHO Global Surveillance and Monitoring System Report, 2017
These two examples illustrate why we need good regulatory oversight of health products. In the first case, action was taken early enough to avoid long-term consequences; in the second, action came too late to avert at least 11 tragedies.
"True access and the health gains that come with it can only be achieved if globally, regionally and nationally health products do what they are meant to do - prevent illness and improve people's health. They can only do that if sound regulatory systems are in place."
Mariângela Simão, Assistant Director-General for Medicines and Health Products.
Despite global progress, serious problems with health product quality and safety persist, particularly in lower- and middle-income countries. These problems threaten the health of people every day and waste resources. Quality and safety of medicines, vaccines and other products are compromised when manufacturers, whether by accident or intent, produce substandard products, when the supply chain allows unsafe medical products through, and when systems (usually due to lack of resources) are too slow to respond to adverse events.
Current regulatory capacity and enforcement are insufficient in most developing countries. WHO estimates that only 3 out of 10 regulatory authorities globally function according to acceptable standards. To compound that, manufacturing of health products has become increasingly globalized, with products and the materials that go into them crossing several borders before they reach patients, requiring even greater global vigilance. And with the rise of non-communicable diseases, such as cancer, cardiovascular conditions and diabetes, regulatory authorities in developing countries are facing greater workloads and new demands to regulate innovative products.
Universal health coverage will bring about greater access to medical products, but we must ensure that those products are quality-assured, safe and effective so that they do what they are supposed to do - prevent illness and improve people's health. That is why today's launch of WHO's five-year plan 'Delivering Quality-assured Medical Products for All 2019-2023' is important.
The plan outlines work and activities to reach four main objectives:
- Strengthen country and regional regulatory systems - improving the functioning of regulatory authorities but also speeding up product registration timelines so that patients can get the product sooner, and facilitating cross-border collaboration;
- Increase regulatory preparedness for public health emergencies - equipping regulators with the knowhow to deal with emergencies, including by fast-tracking product approval processes and improving crisis communication;
- Strengthen and expand WHO prequalification - WHO prequalification of priority health products has contributed to treating millions of people with quality, cost-effective HIV medicines, as well as to the vaccination of millions of children through Gavi, the Vaccine Alliance. It is now expanding to include cancer medicines as the cancer burden grows in low- and middle-income countries;
- Increase the impact of WHO's Regulatory Support activities - by aligning work across all levels of the organization, with particular attention given to countries' needs.
Providing oversight of health products throughout their lifecycle - from laboratory to health facility - is the linchpin of effective prevention, diagnosis and treatment and an essential part of WHO's drive towards universal health coverage. While WHO has worked to improve the quality and safety of health products for many years, this is the first time we are aligning goals and activities with global partners (Bill and Melinda Gates Foundation, UNITAID, The Global Fund to Fight AIDS, TB and Malaria, GAVI and UNICEF) to ensure full coordination and work towards a common goal - to deliver a safe and quality-assured supply of medicines, vaccines, medical devices and other health products for all populations.
External assessment report of the programmes, prequalification and regulatory supporting activities
WHO makes available the outcomes of an external assessment report of the programmes, prequalification and regulatory supporting activities. The review aims to increase a fact-based understanding of the impact and value of WHO's work on prequalification of medicines, vaccines and in-vitro diagnostics and supporting regulatory activities, including norms and standards setting, regulatory systems strengthening, safety monitoring and vigilance.
- WHO Prequalification (PQ) programme enables a core market of approximately US$3.5 billion with the majority coming from vaccines
- WHO PQ has a Return on Investment of 30-40 to 1 for the PQ-enabled donor-funded market (US$ million)
- Most donors and procurers and implementing partners view PQ approval as equivalent to approvals by stringent regulatory authorities
- 340-400 million more patients have access thanks to resources freed up by PQ
- National regulatory authorities (NRAs) relying on Collaborative Registration Procedure (CRP) have achieved significant acceleration of approval timelines vs pre-CRP registrations
Impact on countries:
- Since 1997, WHO trained more than 8'000 NRA staff worldwide and number of functional NRAs increased by 70%
- Four types of inspection-related capacity building activities are held to support local NRAs
- A positive correlation is observed between the number of substandard and falsified medical products reported and the number of trained focal points
- Number of reports on adverse events in medicines has increased in regions with extensive training activities
- Number of countries with basic vaccine safety monitoring system has increased with workshops held in the regions
Opportunities for improvement:
- Improve external communication and operational efficiency
- Strengthen cross-functional collaboration and communication
- Increase cooperation with entities outside of the department, e.g. emergencies, procurement
- Continue efforts to expand existing PQ-product list with a more end-to-end lifecycle view
- Increase awareness of WHO support provided during the early development phase of a product