International trade in pharmaceutical drugs and their components is placing new burdens on regulators and manufacturers’ ability to ensure drug safety and quality. Many cases over the past several years have highlighted the international drug-safety challenge: a fake component was found in the widely used blood-thinning drug Heparin in the United States; a deadly chemical normally found in antifreeze, was used to sweeten cough syrup in Central America; and saline was sold as malaria vaccine in Africa and South Asia.
Oxfam America’s Rohit Malpani says more must be done to build domestic regulatory agencies to identify low-quality and fake medicines. International law expert Daniel Spiegel calls for a coherent definition of bad medicines and components so that international coordination can move forward. Charles Clift of Chatham House contends that a "global alliance of regulators" is needed "to get a grip on this very complex supply chain." Likewise, Brazilian regulator Patricia Pereira says the biggest challenge faced internationally is a lack of communication and familiarity with regulators from different countries.
EDITOR’S NOTE: For more on the issue of drug safety, read about this recent CFR symposium.
The World Health Organization shows that over 30 percent of all countries have no or inadequate drug regulatory authorities, even as most of the developed world spends up to a billion dollars a year improving drug quality or safety. We hope that in the future, developing countries receive the resources both at the national level and the international to be able to identify medicines as falsified, substandard, or counterfeit, and to keep them from entering the country or going to patients in poor countries.
If a person cannot afford a good-quality medicine, because it is too expensive; whether it has a patent or it does not have a patent, they often turn to informal sellers and informal shops, and even to criminal networks to buy medicines.
Intellectual property does play a very limited role in dealing with quality of medicines. Under the World Trade Organization rules, counterfeits are defined as medicines that are criminally infringing trademarks. The problem is people are seeing intellectual property as the only solution. The broader solution is to build drug regulatory authorities that can identify poor-quality medicines, whatever they may be, and remove them from countries.
More than that, the affordability of medicines does matter to the ability of patients to get good quality medicines. If a person cannot afford a good-quality medicine, because it is too expensive, whether it has a patent or it does not have a patent, they often turn to informal sellers and informal shops, and even to criminal networks to buy medicines. So, to the extent that we increase affordability in poor countries, including the use of flexibilities in intellectual property rules, to increase generic competition, we are also going to help deal with the problems of poor-quality medicines.
There’s a question of will as advanced countries from the developed world struggle with drug safety to try to get their own houses in order but also focus on the lack of capacity in the developing world. There clearly needs to be a multilateral solution to this problem, but there is a lack of consensus on a multilateral approach.
Hopefully, once a consensus emerges on what counterfeits are and how they should be regarded in the international community, we can get back to the work of a multilateral approach, which will supplement a lot of the bilateral efforts going on both among nations and also within individual national contexts.
The World Health Organization a couple of years ago developed an innovative program, bringing in Interpol and giving it a standard-setting role in operational capability. That program has been undermined by a lack of consensus from governments like Brazil and India, which see their own generic industries threatened by a move against counterfeit, falsified, and adulterated medicine. That does not have to be the case.
There is an effort going on now to seek a better definition [of counterfeit or false drugs]. Hopefully, once a consensus emerges on what counterfeits are and how they should be regarded in the international community, we can get back to a multilateral approach, which will supplement a lot of the bilateral efforts going on both among nations and also within individual nations
[There needs to be] inspection at the border, and inspection at the manufacturing site to ensure that even legitimate, branded products have the active ingredients that they are advertised as having. That is a question of resources. To inspect the samples of these drugs, you need a lot of resources and a lot of inspections. You also need regulatory authorities in the countries like China and India, which are the source of thousands of these active ingredients, to enhance their own regulatory structures.
The drug safety issue is a problem that has two components. One is, how do we protect the legal supply chain? If all my active ingredients and many of my finished products are produced overseas, I can’t possibly inspect all those plants that are producing them, so what is the answer to that? We have to take different approaches, collaborate more, share more information, and generally have a global alliance of regulators who will try to get a grip on this very complex supply chain.
We can’t inspect every single plant so we have to take different approaches, collaborate more, share more information, and generally have a global alliance of regulators who will try to get a grip on this very complex supply chain.
The other aspect is: What do we do about drugs, which are essentially illegal [because they are complete fakes or contain fake components that can sicken or kill people]? They are not submitted to regulators, they come into the country illegally or they are produced in the country illegally, and they can do enormous harm to individuals. There we need regulators to have a role, but really their role is in stopping this happening, to the extent that they can’t stop it happening. It’s a matter for customs; it’s a matter for police. It’s a matter for a number of different law enforcement agencies that also need to collaborate more closely, so that we can address the problem of these criminal producers of falsified medicines.
We have to develop institutions that seek to address these problems, which are caused by people who are greedy, immoral, and seek to make money after causing people harm and death.
It isn’t possible for just one single agent to proceed with all the inspections needed and to verify the whole [global supply] chain for drugs, and also to be in every pharmacy checking if it’s falsified or not. The biggest challenge we have is there is not that much communication internationally. We need to enlarge communication abroad and increase the level of reliability from our manufacturers.
We have to begin to negotiate confidentiality agreements with agencies [in other countries] and make an on-the-ground effort to work together to share responsibility.
There are a lot of different agencies involved in [overseeing pharmaceuticals]. We [as regulators], have to get to know everybody. We are already in a procedure of negotiations to establish a regulatory dialogue, so that each of them can get to know each other and trust in the procedures in our territory.
We have to begin to negotiate confidentiality agreements with agencies [in other countries] and make an on-the-ground effort to share responsibility. Included in that is our responsibility to perform as best we can as a regulatory agency.