TTIP and pharmaceuticals: possible side-effects

From presentation by TACD at TTIP stakeholders event on July 15th, 2015

 At TACD we are afraid that while some proposals on the table are positive, others could chill future reform or lock us in old business models of biomedical innovation that could work against the common good, affordable medicines and transparency.

There are few proposals, some of which have been under discussion before TTIP, that are win-win propositions within EU-US cooperation, like the joint technical inspections of third-party installations or the sharing of data on pharmaceuticals. We support common- sensical cooperation on these kinds of issues that could save time and money.

At the same time we are concerned that new trade rules could trump some important public health and affordable access guarantees.

We sincereley hope that pricing and reimbursement procedures being considered in TTIP are not adopted by the negotiators. These measures would force Governments to have to give cumbersome justifications for choosing a less expensive medical product. EU member states should not have to jump through torturous hoops or have short time deadlines to decide on drug procurement pricing or purchases. See: http://www.beuc.eu/publications/drug-pricing-and-reimbursement-decisions-have-no-place-ttip/html

The elements that constrain governments from choosing the best and most affordable medicine for procurement, that are present in other free trade agreements, such as the EU-Korea FTA, should not be in TTIP. Governments should not be under  pressure to buy medicines without proof that they work (often important information is precisely hidden as commercially sensitive).

TACD is also worried that new trade secret and commercial confidentiality rules included in TTIP could limit clinical trial transparency and inhibit or chill future open innovation models for affordable, accessible and effective medicines. As well, extending commercial confidentiality through trade secret rules could hurt the sharing of scientific data in open innovation, limit transparency of biomedical R and D investments and block key life-saving information on the safety and efficacy of medical products.

Another important cross-cutting issue in TTIP that could also impact access to medicines is investor protection or ISDS(investor-state dispute scheme). ISDS allows investors to challenge sovreign decisions by Governments and, whether these challenges are successful or not, could chill future legisaltion for affordable and innovative medicines in the EU and US. This specially affects the patentability of new medicines, trademarks, transparency and other public health issues. For example, ISDS has permitted a 500 million dollar case brought by Lilly against Canada because Canadian courts rejected a number of patents for their products. It is concerning that tobaco companies are using ISDS against public health laws on plain packaging of cigarrettes.

TACD is also against any proposals in TTIP that would mean the prolongation of patent monopolies over biomedical products such as the proposal to extend patent protection for biological drugs which would mean significant delays in the access to affordable generic mediciines.

While EU-US could produce many consumer-friendly results, we are concerned that EU-US regulatory cooperation institutionalized in TTIP that would consider new legislation on both sides of the Atlantic could mean that phamaceutical policy will be subject to even greater industry lobbying and that any new legislation could be greatly slowed and influenced. The proposed Regulatory Cooperation Council could have the secondary effects of regulatory chill and even greater lobby power in favour of corporate capture of policy given the disfavourable relationship of forces between industrial interests and the public health interest of consumers and citizens.

With pharmaceuticals on the table during this week’s TTIP negotiations, we expect negotiators to consider that most of these decisions should be an exclusive competence of national governments and have no place in an EU-US trade deal, especially if these measures could mean more problems for the affordability, efficacy and safety of our medicines.

For more detail and information please see: http://test.tacd.org/wp-content/uploads/2014/01/TACD-IP-15-13-IPR-in-the-Transatlantic-Trade-and-Investment-Partnership.pdf http://www.beuc.eu/publications/beuc-x-2015-064_ipa_ttip_health_beuc_position.pdf and http://tacd.org/wp-content/uploads/2013/09/TACD-IP-Resolution-on-access-to-medicines.pdf

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