from the it's-the-law dept
Back in February, we reported that PhRMA, the Pharmaceutical Research and Manufacturers of America, was pushing to have the EU put on the US’s ‘Priority Watch List’ for its plans to disclose basic safety information about drugs. Now a letter from PhRMA obtained by the German newsapaper Der Tagesspiegel shows that US pharmaceutical companies are trying to use TAFTA/TTIP to undermine the new EU rules on making clinical trial data available (original in German):
A letter from the U.S. pharmaceutical association (PhRMA) to the TTIP chief negotiator for the United States, Douglas Bell, states: “The disclosure of confidential data from clinical and pre-clinical study files and patient data puts at risk the health system and the well-being of patients.” Why more transparency should harm the health systems, the lobby group doesn’t explain, but it makes clear to the negotiator how he should conduct the negotiations with the EU: the publication of commercially-sensitive data from a market authorization, the PhRMA letter said threateningly, is not only contrary to the rules of the American FDA, but also to the internationally-accepted intellectual property rights of the World Trade Organization, the so-called TRIPS Agreement. “PhRMA and its members call on the U.S. government to influence the EU at all levels in order to eliminate this problem.”
It’s hard to see how the problem can be “eliminated.” Back in April, the European Parliament adopted the Clinical Trials Regulation by a huge majority. Effective from 2016, it states that information from clinical study files “should not generally be considered commercially confidential” and must be made publicly available — exactly what PhRMA is lobbying against.
What’s worrying is that there’s already been one attempt to water down these requirements. Der Tagesspiegel suggests this may have been as a result of pressure from the European Commission, concerned about US reaction to them. It will be interesting to see how the Commission reconciles any US demands during the TAFTA/TTIP negotiations to remove the requirement to publish drug safety information with the new EU regulation that requires it.