BRUSSELS, Jan 7 (APM) - The European Union took a major step on Wednesday towards critics of its negotiations with the United States over healthcare policy, releasing a citizen-oriented defence of its approach, and emphasising that existing rules on drug prices and access to trial data will not be affected by any new trade treaty.
“EU member states will continue to take decisions on the pricing and reimbursement of medicines”, says a document published by the European Commission, as part of a package of information aiming to justify the EU’s positions in the ongoing talks on the Transatlantic Trade and Investment Partnership (TTIP).
The Commission acknowledges that public concerns have been expressed over sensitive areas of negotiations - citing allegations that TTIP will change the way public authorities decide on the pricing or reimbursement of medicines. But it insists that the current arrangements “will not change with TTIP nor with any other trade agreement”.
It also highlights anxieties on access to trial data. To counter suggestions that TTIP could undermine EU policy on releasing data from clinical trials, the Commission says “in October 2014, the European Medicines Agency published its final policy on publication of clinical data. TTIP will have no influence on this policy nor on the Regulation on clinical trials”.
Similarly, on patent law, it rebuts suggestions that medicines will be more difficult to get and more expensive because there will be more protection of intellectual property rights.
“Both the EU and U.S. have a solid and comprehensive intellectual property rights system which allows innovation companies to thrive and to remain among the most competitive in the world”, says the Commission. “We will not negotiate any IP rules that change this delicate balance or put more strain on already stretched national health budgets.”
The main claim in the Commission’s public document is that a deal could improve access to generics.
In this chapter of the wide-ranging TTIP negotiations, the Commission says it wants to “make the access to complex medicines easier and cheaper for patients - TTIP could foster the development and approval of generics (biosimilars) of biological medicines, such as vaccines and insulin”.
It says it also wants to improve and speed up the way generic medicines are approved, including the rules on what information needs to be submitted to EU and U.S. authorities in the process.
“We will work together on our requirements for approving 'biosimilars' - products similar to already licensed biological medicines, such as vaccines, and streamline systems for authorising generic drugs”, it says.
The ambitions set out by the Commission also include “making sure that special medicines for children or other speciality products, like medicines for rare diseases, are available for the patients that need them”.
The EU and the U.S. also want to “recognise each other's Good Manufacturing Practice inspections of manufacturing plants, so we don't unnecessarily do the same work twice”.
There are also less clearly specified aims with potentially broader reach. The list means “exchange information between regulators - this helps them when they have to decide whether or not to approve new medicines”.
The talks are intended to “strengthen our collaboration under the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use”, and “pave the way for closer EU-U.S. collaboration in areas not covered or insufficiently covered internationally”.
And there is a desire to “support the joint development of compatible regulations on innovative areas not yet fully regulated.”
Overall, the Commission says a TTIP deal should “make it easier and cheaper to sell some U.S. medicines on the EU market, and EU medicines in the U.S., and to support each other as we develop regulations in new areas.”
TTIP comes on top, says the Commission, of extensive work with the U.S. in the area of pharmaceuticals/ “For example, we have already removed tariffs. This is also valid for regulations.”
But there is still work to be done, the Commission concludes, and “with TTIP, we can strengthen this collaboration and make a difference for consumers and the industry.”
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