EU-US deal could liberalise transatlantic pharma trade

The European Union (EU) might accept US-made pharmaceuticals as safe enough to sell in the EU without full-scale European controls, under a planned EU-US Transatlantic Trade and Investment Partnership.

The European Commission (EC) has released initial negotiating documents, which indicate that Brussels could be prepared to accept some US standards under a mutual recognition formula and through harmonisation or approximation of technical regulations in others. It would try to achieve ‘increased compatibility/convergence in specific sectors, including through recognition of equivalence, mutual recognition or other means as appropriate’, said one document, which added that special commitments regarding pharmaceuticals could be written into the agreement.

Another negotiating document stressed that ‘further commitments pertaining specifically to services sectors (e.g chemicals, pharmaceuticals) would be included respectively in the TBT [technical barriers to trade] and SPS [sanitary and phytosanitary] chapters and sectoral annexes/provisions’.

And it noted that a deal would build on existing co-operation deals, such as that linking the market approval work of the European Medicines Agency (EMA) and the US Food & Drug Administration (FDA). ‘There are a number of distinct technical areas in which the parties already co-operate more closely, such as in motor vehicles, pharmaceuticals and medical devices.’

It added that a deal could mean ‘companies wouldn’t have to repeat some tests’, saving money for both companies and regulators.