January 31, 2016
Genval, 31st January 2016. – Is it really apropriate to raise this question, after the European Parliament’s Legal Affairs (JURI) Committee has endorsed a trilogue deal with the Council on Trade Secrets with an overwhelming political majority (EPP-S&D-ECR-ALDE-EFDD-ENF(!))?
I think it is as I believe some of the key public interest concerns were not taken into account as much as private business interests. In public affairs sometimes we win, sometimes we loose. As the conception of ‘Trade Secrets’ protection is about protecting private commercial interests, it is no surprise that the business sector could easily gather enough lobby support to get this deal done.
What are those (temporarily) lost public interests? You can have a look at the end at a short letter circulated among trilogue negotiatiors in December 2015 which highlights the key public interest warnings, including public health concerns. What are the latters? Well, the definition of ‘trade secret’ is too vague and there is no clear exclusion of clinical trials. Therefore, if a company decided that it has commercial interests in some clinical trials data and it denied to publish them, there is no legal safeguard to prevent this, which worries me. Clinical trials data transparency is key for patient safety, for acess to affordable medicines, for public health research and innovation.
What could be the implications for the Trade and Investment Partnership (TTIP)? Well, I suspect that after the adoption of that directive, this conception will be represented during the EU-US transatlantic deal, as an EU ‘standard’ so we might end up using this ‘Trade Secret’ definition in a transatlantic dimension. Although it must be added that if I consider that the US protection of trade secrets is even stronger with criminal sanctions (see the Snowden case) the European interpretation of it might be the less bad option.
What are the next steps? Well, the chance to turn this vote back at the EP plenary is only mathematical, even if the JURI committee does not represent the whole Parliament. The constructive public interest group recommendations could not be taken into consideration at this late stage, as the final vote is a yes-or-no vote only. However I believe, our duty as public interest advocates is to try even the impossible and represent the right cause even, if we fail at the end. Doing the right thing is always worth and there must be still hope that our lost is just temporarily.
Explanation – Trade Secrets and Public Health
Pharmaceutical companies argue that all aspects of clinical development should be considered a trade secret. Access to biomedical research data by regulatory authorities, researchers, doctors and patients—particularly data on drug efficacy and adverse drug reactions—is critical, however, for protecting patient safety and conducting further research and independent analyses. This information also prevents scarce public resources from being spent on therapies that are no better than existing treatments, do not work, or do more harm than good. Moreover, disclosure of pharmaceutical research is needed to avoid unethical repetition of clinical trials on people. The proposed directive should not obstruct recent EU developments to increase sharing and transparency of this data.
[embeddoc url=”http://zmk.blogactiv.eu/files/2016/01/TradeSecretsDirective_NGOJointletter_3rdtrilogue-2015-12-03.pdf” download=”all”]Author : Zoltán Massay-Kosubek