EU To Open Up Secret Clinical Trial Data; TPP Looking Even More Retrogressive | Techdirt

“Openness is really beginning to sweep through the European Union at all levels. Yesterday we wrote about the European Commission's ambitious plans to make the results of publicly-funded research freely available as open access; now comes news of a major opening up in the world of pharmaceutical data: ‘Europe's medicines regulator, criticised in the past for excessive secrecy, is opening its data vaults to systematic scrutiny in a move that will let independent researchers trawl through millions of pages of clinical trial information. The change is a landmark in transparency that puts Europe ahead of the United States, according to critics of the $1 trillion-a-year global drugs industry, who have long argued for full access to trial data. Such information is a treasure trove for scientists wanting to test drug company claims and potentially expose product deficiencies.’ Pharma companies are keen to keep that data locked away for another reason: it acts as a very effective barrier to manufacturers of generics, who are unable to use existing clinical results in order to get approval for their drugs. Indeed, extending drug data exclusivity is one of the key proposals of the TPP agreement, as this analysis of two leaked US documents explains: ‘If pharmaceutical companies can get substantially longer data exclusivity, especially if it contains mechanisms for evergreening exclusivity such as that involving biologics, they won’t have to rely on patent protections to obtain marketing monopolies. Data monopolies of sufficient length will be superior to patents from the perspective of pharmaceutical firms because data monopolies give the same or higher level of monopoly protection without the need and expenses of proving that the product meets the relatively high standards for patentability.’ That makes the EU's planned move even more significant, since it would signal that TPP's proposal to extend data exclusivity is not the only approach when it comes to regulating medicines, and that greater openness is also an option.”