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Poor quality medicines are a serious threat to our health. Falsified medicines and substandards medicines are a problem for all countries, but particularly for low and middle income countries where we see, for example, a large epidemic of fake anti-malarial drugs. Globally, better medicine regulatory authorities will help improve the quality of our medicines.

This is a podcast from the Nuffield Department of Medicine. Today we speak with Professor Paul Newton about the issue of poor quality medicines.

Q: Why are poor quality medicines such a problem?

Paul Newton: I think they are a major problem for global public health because most of us take medicines. They are a crucial part of our well-being, curing disease and preventing disease. If they do not contain what they say on the packet, if it contains none or less of the stated ingredient, then that is clearly a severe problem for our health.

Q: How common is it to come across a poor quality medicine?

PN: They are very variable across the world; no countries are immune. There have been recent severe problems in the US and elsewhere in the wealthy world, but the people most affected by this are the most vulnerable people in lower and middle income countries who do not have the facilities or the regulatory authorities to regulate and police the drug supply. One current example is a large epidemic of anti-malarials in west and central Africa where many countries have in the distribution chains falsified anti-malarials containing no active ingredients. So patients with malaria will effectively have no treatment, and that is a major issue across large parts of Africa.

Q: How can this situation be improved?

PN: I think the key thing is more political will, more interest in the subject, but the most crucial and practical intervention is to improve medicine regulatory authorities globally. We are very lucky in the UK in having a very active, well-funded medicine regulatory authority, but WHO estimates that two thirds of nation states do not have that. They are the key stones for improvement and regulation of the drug supply, and without that I don't see how we can have a good drug supply.

Q: What are the most important lines of research that have developed in the past 5-10 years in this area?

PN: The key thing has been a better understanding of the epidemiology of the problem globally: where it is a problem, what are the driving forces for it, and an increasing understanding that there are two different types of poor quality medicines. Falsified medicines, which are otherwise known as 'fakes', that usually but not always contain no active ingredient and will have no therapeutic efficacy if one was to take them. And substandard medicines that are the results of poor quality manufacturing by genuine manufacturers, which is a problem of negligence and errors rather than deliberate criminal fraud.

Q: Why is this research so important and why should we fund it?

PN: Globally most of us take medicines and if they are not what they say they are, if they do not contain the right active ingredients, if they contain the wrong active ingredients or no active ingredients, that will inevitably impact on all of our health. It is a crucial thing that we need to get sorted and it is rather extraordinary that in 2016 we still have multiple cases of poor quality medicines globally.

Q: How does this research fit in with translational medicines within the department?

PN: I think it is intrinsically a translational work. In the research we are doing, the aim is to influence health policy, directly to give evidence, to raise its political profile and to use it to try and insure that we do see, for the next generation, an improvement in medicine quality.

This interview was recorded in September 2016

Paul Newton


Professor Paul Newton is the director of the Wellcome Trust-Mahosot-Oxford Collaboration Unit in Vientiane, Lao. LOMWRU researchers conduct clinical research to help improve global, regional and Lao public health. They focus on infectious diseases, and also investigate diseases of nutrition and poverty.
Professor Newton is also Head of the IDDO Medicine Quality Group.

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