PhRMA Wants US To Use TAFTA/TTIP To Stop EU Releasing Basic Drug Safety Information

from the it's-the-law dept

Back in February, we reported that PhRMA, the Pharmaceutical Research and Manufacturers of America, was pushing to have the EU put on the US’s ‘Priority Watch List’ for its plans to disclose basic safety information about drugs. Now a letter from PhRMA obtained by the German newsapaper Der Tagesspiegel shows that US pharmaceutical companies are trying to use TAFTA/TTIP to undermine the new EU rules on making clinical trial data available (original in German):

A letter from the U.S. pharmaceutical association (PhRMA) to the TTIP chief negotiator for the United States, Douglas Bell, states: “The disclosure of confidential data from clinical and pre-clinical study files and patient data puts at risk the health system and the well-being of patients.” Why more transparency should harm the health systems, the lobby group doesn’t explain, but it makes clear to the negotiator how he should conduct the negotiations with the EU: the publication of commercially-sensitive data from a market authorization, the PhRMA letter said threateningly, is not only contrary to the rules of the American FDA, but also to the internationally-accepted intellectual property rights of the World Trade Organization, the so-called TRIPS Agreement. “PhRMA and its members call on the U.S. government to influence the EU at all levels in order to eliminate this problem.”

It’s hard to see how the problem can be “eliminated.” Back in April, the European Parliament adopted the Clinical Trials Regulation by a huge majority. Effective from 2016, it states that information from clinical study files “should not generally be considered commercially confidential” and must be made publicly available — exactly what PhRMA is lobbying against.

What’s worrying is that there’s already been one attempt to water down these requirements. Der Tagesspiegel suggests this may have been as a result of pressure from the European Commission, concerned about US reaction to them. It will be interesting to see how the Commission reconciles any US demands during the TAFTA/TTIP negotiations to remove the requirement to publish drug safety information with the new EU regulation that requires it.

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Companies: phrma

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Comments on “PhRMA Wants US To Use TAFTA/TTIP To Stop EU Releasing Basic Drug Safety Information”

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andypandy says:


maybe people will realise that most pharmaceuticals coming from America are only 1% effective in any given population and that they are useless as a tool to help the sick.

I would not be surprised if many medications were banned due to lax testing and dangerous results from pharma testing or where only 10 people were used in a test.

this could get very interesting if the EU has a backbone in this situation.

Anonymous Coward says:

Re: Re: uh

I wouldn’t be surprised if what he said was true. Cynical, I know but here is the reason.

Comparative effectiveness research (CER) was nearly completely missing from the US for a long time.

The American FDA doesn’t exactly control shit either. They can hardly even stop doctors from getting fed bullshit about what drugs do what.

Anonymous Coward says:

Please let them have enough backbone to make a stand for something obviously good for once.
I hope it will be revealed that the drug industry isn’t as bad as we fear, but I don’t think that will be the case.
From experience with greedy corporations over the years, I very much think it will be much much worse. Scandals which shows very dangerous hidden side effects that have cost tens or hundreds of thousand of lives combined.
Can this reveal previous studies or just new ones from 2016 and forward?
If not then they just change their tactics, which will cost them a bit of money, but they would get away with what they might have done in the past.

Anonymous Coward says:

Re: Re:

If they get this through, they are pushing the European Parliament to the point where they may even consider voting against TTIP. The openness on documents in general is a huge and hardfought win for the parliament in EU and one of their primary bragging points. Smashing that legislation before it is implemented will make TTIP divisive at best and at worst completely doom the treaty from passing.

The real question is if they are willing to push that to get concessions from the commissioner. I would think they can, but it is pretty high stakes since not getting the treaty passed is a fear of all parts in the negotiations…

Anonymous Coward says:

Re: Re:

Welcome to pharma vs South Africa part 2. There was a reason the Doha treaty was implemented…

The openness arguably holds even bigger potential for helping research if EU can get it working. Unfortunately the resistance seems to be strategic/economic in nature. If other companies can allude things from the documents, they will be better equipped to improve and market a competitor. That is not ideal for an industry where the preinvestment is counted in millions or billions of dollars and the economy depends a lot on fighting free market forces.

Anonymous Anonymous Coward says:

Pharma Consternation's

Not only should the public have access to all anonymized trial data, especially all the adverse reaction information. We also need to take a serious look at what standards the FDA is using. The ads for prescription medicines on TV often have dangerous effects that sound worse than the issue they were designed for.

Which brings up another point. Why is Pharma allowed to advertise to the general public when only a doctor can prescribe? Do doctors really respond when a patient comes in and claims to have XYZ symptoms (a list taken from the advertisement) and they need compound ZYX to cure it? Or do the doctors say, ‘Let me run some tests and we will see what the best course of action is’ (they can bill more for the tests at least)?

Anonymous Coward says:

‘see how the Commission reconciles any US demands during the TAFTA/TTIP negotiations’

what negotiations?? all that ever comes from the USA, the only country that is responsible for starting these type of ‘negotiations’, are demands for everything that aids USA businesses and the country while totally fucking up every other country (that is forced to be part of those ‘negotiations’ to begin with or being threatened with some sort of action against them and their citizens if refusing!) and the citizens! why no one seems to have the balls to step away right at the beginning, i dont know. are the negotiators bribed so well?

Anonymous Coward says:


The disclosure of confidential data from clinical and pre-clinical study files

There is only one reason that any of the relevant/analytical parts of a clinical study would contain confidential information linked to the real identities of subjects: to use “privacy” as an excuse to hide the results from the public.

Any trial involving the actual names of subjects being carelessly tossed about should be declared invalid, and distribution/sale of applicable drug suspended until a real (anonymized) study is completed by the manufacturer. They can try to hide it if they want to, but at least they’ll have lost the BS “privacy” excuse.

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