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Regulators set to deepen transatlantic ties

Written by | 22 Apr 2015 | All Medical News

by Gary Finnegan: Medicines watchdogs on both sides of the Atlantic could significantly step up collaboration if a new transatlantic trade deal is sewn up later this year.

The Transatlantic Trade and Investment Partnership (TTIP) has been under negotiation since 2013 but is expected to be signed by the end of 2015.

One of the key areas currently in the spotlight is healthcare where enhanced regulatory cooperation – primarily on medicines approval – is on the table.

The European Medicines Agency and its US counterpart, the Food and Drug Administration (FDA) have been slowly strengthening exchange of information in recent years but the new trade deal would be a catalyst for further integration.

The exchange of information on regulatory inspections and clinical trials are on the agenda in the coming months but mutual recognition of drug approvals is not on the cards, according to reports.

Proponents of the trade deal say it would bring efficiencies for companies, cutting compliance costs and ultimately making it cheaper to bring a new product to market in the EU and US.

However, there has been considerable scepticism from some quarters, including from the European Parliament where the health committee has called for healthcare to be exempted from TTIP entirely.

They argue that stark differences between health service delivery and approaches to issues like cloning and stem cells mean EU-US cooperation can only go so far.

If a deal can be reached it would cover around 40% of the world’s trade and, according to negotiators, has the potential to boost EU’s GDP by around 0.5%.

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