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CRITical Thinking is a blog written by staff, directors, and friends of the Collaboration for Research Integrity and Transparency (CRIT), a joint program of Yale Law School, Yale School of Public Health, and Yale School of Medicine. CRIT's mission is to promote health by improving the integrity and transparency of biomedical and clinical research.

This blog is published by and reflects the personal views of the individual authors, in their individual capacities. It does not purport to represent Yale University's institutional views, if any. No representation is made about the accuracy of the information, which solely constitutes the authors’ personal views on issues discussed. The information contained in this blog is provided only as general information and personal opinions, and blog topics may be updated after being initially posted.


Work Locally, Coordinate Globally

February 22, 2018

In June 2017, Yale CRIT hosted an international conference titled "Ensuring Safety, Efficacy, and Access to Medical Products in the Age of Global Deregulation." The following blogpost is the thirteenth installment of a blog series with commentaries from the conference participants. The views and opinions expressed in this blogpost are those of the author and do not necessarily reflect the position of Yale CRIT. For more blogposts related to this series, see here or click the tag "YaleCRIT17" below.

I've been working in the area of pharmaceutical policy now for almost 40 years, mostly in Canada but also in other parts of the world. Listening to what was said at the Yale CRIT conference last June and reflecting on my experiences from living in Australia and New Zealand, working for many years with colleagues and friends from Europe and interacting with Americans, I think that there are a number of problems that are common in all parts of the world. Among these are: the political and economic power of the pharmaceutical industry, the way that intellectual property rights interfere with access and affordability of medicines, the poor evidentiary base for the safety and effectiveness of many medicines and the increasing ties between regulators and industry, that result in the weakening of regulatory standards.

However, although problems are common, they need to be seen in the context of individual countries and regions because, depending on circumstances, the priorities for dealing with them and how they can be tackled will be different. What is most important in Canada or Australia is not necessarily what is most important in Europe or in low- and middle-income countries, but the reality also is that what happens in the U.S. or Europe will affect what happens everywhere else in the world. If changes are not made in these two jurisdictions, then change elsewhere will be extremely difficult. Our challenge is to be able to work locally but coordinate what we are doing internationally.

Here we might want to look at how the pharmaceutical industry functions, both on a company level and through its international organizations such as the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The industry also needs to consider the local context but coordinate what it is doing on particular issues internationally. Of course, industry has many more resources at its disposal compared to what we have, but I think that this meeting is a good first attempt to start to coordinate our energy and expertise.

At the same time, we also need to recognize that pharmaceutical policy won't change just because a group of experts talks about the evidence. Policy makers and politicians have shown over a long period of time that they are very capable of ignoring evidence, just witness what is happening in the U.S. with Trump's plan to reduce drug prices. We need to find ways of engaging not just our own local communities but the public in general in order to help them understand the issues. In the long-run, it will be public pressure that will force the changes that are needed to ensure that medicines are safe, effective, easy to access and affordable.


Joel Lexchin taught health policy at York University in Toronto from 2001 to 2016 and since 1982 has worked as an emergency physician at the University Health Network. His two most recent books are: Private Profits vs Public Policy: the Pharmaceutical Industry and the Canadian State (University of Toronto Press, 2016) and Doctors in Denial: Why Big Pharma and the Canadian Medical Profession Are Too Close For Comfort (Lorimer, 2017).