PhRMA Wants EU Put On US's 'Priority Watch List' For Plans To Disclose Basic Safety Info About Drugs

from the yeah,-that's-reasonable dept

We've written many times about how the USTR uses its Special 301 Report to bully smaller countries into toeing the US line. One of the most influential organizations providing input into who should sit on this year's naughty step is PhRMA, the Pharmaceutical Research and Manufacturers of America. James Love points out that its submission this year is notable for the following demand: PhRMA requests that the EU be placed on the Priority Watch List for the 2014 Special 301 Report, and that the U.S. Government continue to seek assurances that the problems described herein are quickly and effectively resolved. The European Union is accused of three basic sins, including ineffective patent enforcement -- rather implausible given Europe's extremely strong patent regime in this area -- and daring to take into account the cost of relevant generics when setting medicine prices. But the most interesting complaint is the following: EMA data disclosure policy: PhRMA and its member companies are very concerned that current practices of the European Medicines Agency (EMA) and proposals being advanced through the EMA and the European parliament to provide virtually unrestricted access to and publication of biopharmaceutical companies' clinical trial regulatory submissions and data will substantially harm patient privacy, the integrity of the regulatory system, and incentives for pharmaceutical research and development. Failing to protect confidential commercial information contained in regulatory submissions is inconsistent with the EU's treaty obligations contained in the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and primarily benefits competitors who wish to free-ride off of the investments of innovators. We are especially concerned that proposals to disclose regulatory clinical study reports (CSRs) in their entirety -- a class of document that the EMA has traditionally considered to be commercially confidential information -- will allow competitors to submit innovators' documents to gain regulatory approval in non-European countries. Techdirt wrote about the EMA's plans to make clinical trials data for drugs available (including the key clinical study reports) back in November. As that post explained, this is basic safety data -- not "confidential commercial information" as PhRMA claims in its Special 301 submission. These are simply the scientific facts about a drug that establish what side effects it has, and whether it offers sufficient benefits to be approved for sale.

Drug companies that are confident their products are safe should welcome the opportunity to prove that in a completely transparent manner, and to benefit themselves in multiple ways from this general opening-up. PhRMA's desperate attempt to get the USTR to interfere with the European Union's plans would suggest that some of its members may have something to hide -- a view that recent scandals involving big pharma tend to support.

Follow me @glynmoody on Twitter or identi.ca, and +glynmoody on Google+

Thank you for reading this Techdirt post. With so many things competing for everyone’s attention these days, we really appreciate you giving us your time. We work hard every day to put quality content out there for our community. Techdirt is one of the few remaining truly independent media outlets. We do not have a giant corporation behind us, and we rely heavily on our community to support us, in an age when advertisers are increasingly uninterested in sponsoring small, independent sites — especially a site like ours that is unwilling to pull punches in its reporting and analysis. While other websites have resorted to paywalls, registration requirements, and increasingly annoying/intrusive advertising, we have always kept Techdirt open and available to anyone. But in order to continue doing so, we need your support. We offer a variety of ways for our readers to support us, from direct donations to special subscriptions and cool merchandise — and every little bit helps. Thank you.

–The Techdirt Team

Filed Under: european union, patents, pharmaceuticals, special 301 report, ustr

Companies: phrma