Making medicines and health technologies safe and accessible
The Bulletin interview with Vladimir Lepakhin.
Dr Vladimir Lepakhin gained his MD at the First Moscow Medical Institute in 1964 and his PhD in 1968. He headed the Department of General and Clinical Pharmacology of the People’s Friendship University in Moscow from 1985 to 1998 and for 15 years was Director of the USSR and Russian Drug Authority. He served from 1989 to 1992 as deputy health minister in the former Soviet Union and later, the Russian Federation. He joined WHO in 1998.
Scientific advances have resulted in a vast array of drugs and health technologies to prevent or treat diseases. One of WHO’s roles is to advise and support countries in the provision of these drugs and technologies. When Dr Vladimir Lepakhin became Assistant Director-General for the Health Technology and Pharmaceuticals cluster of departments in 2003, the debate centred on access and affordability. But as the number of new health products grows, WHO is focusing more than ever on their quality and safety.
Q: What is the role of your cluster of departments?
A: Our main task is to help countries achieve a supply of medicines and health technologies that are affordable, high quality, safe and efficacious. At the same time we assist countries to ensure that these medicines and technologies are used appropriately. Until recently, we spoke mainly about access and affordability. Now we have started to pay more attention to quality and safety. Medicines are a doubled-edged sword, they can save lives but they can also kill. According to scientific publications, in the United States alone 100 000–200 000 people die every year due to drug-related complications.
Q: Why do so many people suffer or die from taking medicines?
A: There are several reasons. There are many substandard and counterfeit medi¬cines on the market. Another problem is that many new drugs are highly potent. The more biological activity, the greater the chances of more effec¬tive treatment but also of more serious adverse reactions. At the same time, pre-marketing evaluation of drugs is not enough to discover all possible adverse drug reactions. This is why more and more products are withdrawn. Everyone talks about Vioxx, but this is not the only example. Some drugs are withdrawn after 1–5 years on the market, sometimes after 10–20 years.
Q: How do you decide which company’s products get on the essential medicines list?
A: Products are not decided by company but evaluated on the basis of efficacy, safety, quality and affordability. This list provides suggestions. It’s up to countries to decide what to include on their lists. Some developing countries with little regulatory capacity adopt the whole list, others adapt it to their health priorities.
Q: Why did WHO establish a prequalification list of products?
A: We realized that many products on the pharmaceuticals market are sub-standard. We compile this list for UN agencies to purchase drugs mainly for HIV/AIDS, tuberculosis and malaria treatments that meet unified standards of quality, safety and efficacy. When we started in 2001 we were criticized. Critics said it was not in the WHO constitution or required by a World Health Assembly resolution and that WHO was not a drug agency. But experience has proved we were right. Only 1 in 5 products submitted to us pass our pre-qualification scrutiny and are included on the list. We evaluate products, manufacturing sites and clinical studies. An important part of this work is training people from drug regulatory authorities in developing countries to do this evaluation themselves.
Q: Why is WHO concerned about “irrational” use of drugs?
A: About half of all drug-related problems are due to irrational use. This can start at any stage from prescription by the doctor or advice from a pharmacist to use by patients. Self-medication is very common, practically all families use drugs by themselves. We have a programme to monitor drug-related complications. More than 80 countries have joined it and their national centres have helped us compile a database of more than three million reports of adverse reactions.
Q: Flexibilities introduced into the TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement have made medicines potentially more accessible, but are countries making full use of these?
A: So far very few countries — only Indonesia, Malaysia, Mozambique and Zambia — are using these flexibilities. The idea was good, but its effectiveness will be tested in practice. Many countries do not understand these flexibilities and that’s why we have a special project to advise and show them how to use these. It’s just the beginning.
Q: Are patents a barrier to improving access to essential medicines?
A: Patents are needed because it is complicated and costly to develop new medicines. We need innovative products because there is no effective treatment for some diseases and more and more cases of drug resistance. Patent and price are not the only barriers in improving access. Lack of public health insurance forces people to pay for medicines themselves. Supply and delivery problems also lead to drug shortages.