The Efficiency of Bringing Drugs to Market Versus the Fairness of Making Drugs Accessible

As the 2014 Ebola outbreak continues to spread in West Africa, drug companies, national governments, and public health entities as a whole are coming under increasing criticism for failing to offer what many would view as equitable approaches to addressing public health epidemics, particularly those occurring in poor or developing nations. Indeed, public health threats like the Ebola virus challenge drug companies to find the right balance between making unproven treatments available to desperate populations and ensuring the safety and efficacy of treatments that have yet to undergo comprehensive clinical testing. Furthermore, striking such a balance highlights a medical ethics issue that has haunted some of these drug companies in the past: conducting clinical trials on foreign populations with few of the ethical and safety protections required by western cultures, yet then pricing drugs out of the market for these same populations once they are FDA approved.
[Read more…]

New EU Clinical Trials Regulation

On 16 June 2014 a new Clinical Trial Regulation entered into force in Europe. It will apply no earlier than 28 May 2016.
The new regulation presents a major step forward in harmonizing clinical trial assessment process in the EU. For years, Europe was criticized for having too complicated, non-harmonized, nationally driven procedures for clinical trial assessment which often resulted in timely unpredictable and divergent assessment conclusions. Sponsors were faced with numerous country-specific protocol amendments as result of different opinions of one-country’s Competent Authority and Ethics Committee compared to opinions of other EU countries or even different opinions of Ethics Committee compared to national Competent Authority of the same country. In any case, Sponsors could expect any combination of decisions and close follow up by national experts was necessary.
[Read more…]

Controlling Compliance Risk in Global Clinical Research Activities

To say that globalization matters to pharmaceutical and medical device companies is an understatement. Labor, research, and payer coverage and reimbursement obstacles in North America and Europe, as well as increasing patent challenges, are forcing an intense focus on maximizing development activities and commercial opportunities around the world, including in jurisdictions that were barely on the radar screen in decades past. At the same time, speed to approval in developed markets remains critical, and a significant portion of the value proposition of research conducted in developing markets is often focused on support of approval applications in the US and EU, where the scrutiny of research and publication practices has steadily grown. Taken together, these trends require legal, regulatory, and compliance professionals to pay close attention to how clinical research activities are planned and executed.
[Read more…]