Regulators across many countries have recalled dozens of medicines to treat high blood pressure in recent months 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.
Earlier, 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.
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.
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.