The European Union TTIP negotiating team for the pharmaceuticals, medical devices and cosmetics sectors are meeting in Brussels to discuss issues related to TTIP and health. They will be joined by lobbyists on behalf of the major drug companies such as Novartis, Pfizer, Roche, GlaxoSmithKline, Merck and AstraZeneca, whose industry collectively spends $43 million a year on lobbying within the EU alone.
Critics believe the TTIP — which is a huge trade agreement between the EU and the US, backed by US President Obama — will lead to a loosening of regulations across all sectors, but particularly, the pharmaceutical and health sector, which is heavily regulated in Europe, but less so in the US.
At the heart of the issue is the process of clinical trials, which are required before any new drug can be brought to the market. Because the pharma giants spend huge amounts of money developing new drugs, it is critical that they get approval from the relevant authorities in a timely manner in order to go to market and begin getting a return on their investment. The EU and the US have different regimes.
Only half of all the clinical trials conducted worldwide are published and some are not even registered. The EU has been attempting to open up the process of making clinical trials more transparent under the new Clinical Trial Regulation and the new European Medicines Agency (EMA) policy on clinical data disclosure.
According to the European consumer organisation BEUC: "Europeans will soon benefit from greater access to information regarding the safety and efficacy of their medicines. Notably, this a far cry from the information American consumers have access to.
"TTIP calls for a harmonised definition of 'commercial confidentiality' across sectors and specific confidentiality provisions for pharmaceuticals. As such, we are concerned that the broad definition of commercial confidentiality in the US could hamper the progress made in Europe so far."
Richard Bergstrom, Director General of the European Federation of Pharmaceuticals said: "This is about removing duplication. The biggest benefit will be that we can bring new medicines to patients faster by simplifying the regulatory procedures without lowering the standards."
However, Laura Harrisson, who joined campaigners at the last lobbying meeting in Brussels, writing in Global Justice Now, said:
"Under TTIP big pharmaceutical companies could extend their patents, limit the disclosure of data from their trials which is essential for the production of generics. Worst of all, they could use a clause called the Investor-State Dispute Settlement to sue governments for millions using the argument that government measures to promote access to medicines will negatively affect future earnings on their patented drugs or other investments in the EU."