BIO 2015

TTIP trade talks will 'force' FDA-EMA to sync regs, says biopharma

By Fiona BARRY

- Last updated on GMT

The Transatlantic Trade and Investment Partnership: steamroller or boon to free trade?
The Transatlantic Trade and Investment Partnership: steamroller or boon to free trade?

Related tags European union

Eli Lilly’s President of Biomedicines says the transatlantic trade agreement TTIP will “force” the FDA and EMA to standardise regulations on manufacturing and trials.

Dave Ricks told an audience at BIO 2015 that TTIP is needed "to force regulators to cooperate​" after 25 years of waiting for voluntary harmonisation to work.

What is TTIP?

The Transatlantic Trade and Investment Partnership is a free trade agreement being negotiated between the EU and US.  It will open up their export markets, eliminating all tariffs and other barriers on trade for pharmaceuticals, among other products.

It will also standardise many regulations, and – a sticking point for many dissenters – enforce very strong IP protection.

Nine rounds of negotiation have taken place so far, with implementation expected by the end of next year.  

The regulators have "entrenched positions​" on scientific advice which often differ, such as which comparators to use in trials or the rules on conducting clinical trials on children. The differences force pharma companies to repeat studies, wasting time and money and delaying development, he said.

Novo Nordisk’s Head of Corporate Government Affairs Morten Pedersen, also speaking at BIO, said TTIP will synchronise regulations for manufacturing as well as trials. Under the agreement, FDA and EMA will not need to duplicate each others' inspections of pharmaceutical facilities, as "visits several weeks apart add no extra value and it is better to free up resources,​" he said.

Data: clinical or commercial?

But consumer interests NGO Health Action International said TTIP rules will limit regulators’ and researchers’ access to clinical data to assess drug efficacy.

While EU-US standardisation is generally a good thing, “patient safety shouldn’t be traded away in exchange for increased regulatory harmonisation,” ​said Tessel Mellema, Policy Advisor, HAI.

Mellema told her organisation is “particularly concerned that the European Commission states that, in order to be able to exchange information between regulators across the Atlantic, it plans to regard clinical information exchanged in this context as commercially confidential information.

“This could, for example, mean that the European Medicines Agency bases its decision to grant marketing authorisation on information obtained from the FDA in the US, which it subsequently cannot share with third parties on request. The US has a much less progressive policy on publication of medicines safety and efficacy data than the EU.”

‘An affront to democracy’

Other civil society groups have criticised TTIP’s plan for regulatory cooperation. After a draft was leaked in April,​ campaigners Corporate Europe Observatory called it an “affront to parliamentary democracy,​” saying it will block laws passed by politicians if they are not “compatible with the economic interests of major companies.​”

Both the [European] Commission and US authorities will be able to exert undue pressure on governments and politicians under this measure as these powerful players are parachuted into national legislative procedures. The two are also very likely to share the same agenda: upholding the interests of multinationals,​” said Kenneth Haar, Corporate Europe Observatory.

Regulators’ response

When contacted the EMA for comment, a spokesperson told us it supports the European Commission in its TTIP negotiations.

The EMA/EC and the FDA currently cooperate on pharmaceutical regulations, for instance through an agreement set up in 2003 which allows the regulators to exchange confidential information and work together on scientific advice.

However, there are a number of areas where EU/US cooperation could be further reinforced,” ​said spokesperson Sophie Labbé.

Since May 2014 the regulators have been working on ways “to accept each other’s inspections in order to save precious inspection resources between our two Agencies so that they can be deployed more efficiently elsewhere (in third countries),​” she said.

The TTIP negotiations have confirmed that this objective (i.e. acceptance of each other’s GMP inspections) was shared by both EU and US authorities and was also supported by industry from both sides of the Atlantic.​”

She added the EMA and FDA also already have a programme which allows companies to request parallel scientific advice from the agencies.

The EMA wants finished TTIP rules to bring about “a more efficient and focused use of the resources of the regulators, facilitate building on the best available regulatory practices, and reduce unnecessary duplications (including with respect to clinical trials) for the benefit of patient safety, innovation and greater cost-effectiveness,​” she said.

The FDA had not returned our request for comment at the time of publication. 

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