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

from the it's-the-law dept

Thu, Jul 3rd 2014 12:35am — Glyn Moody

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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Filed Under: drug safety, eu, information, phrma, tafta, ttip
Companies: phrma

24 Comments

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Anonymous Howard (profile), 3 Jul 2014 @ 12:46am

US response
"If you have nothing to hide, you have nothing to fear"
/s
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Anonymous Coward, 3 Jul 2014 @ 12:53am

Disclosing the positive and negative effects these drugs have on people, helps ensure the health and safety of patients. Health and safety is supposed to come before profits.
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andypandy, 3 Jul 2014 @ 2:03am

Maybe
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.
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Anonymous Coward, 3 Jul 2014 @ 2:22am

Mmmm...smells like murderdrugs.
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Charles (profile), 3 Jul 2014 @ 2:25am

Snowpiercer
What right does any manufacturing group have to try and dictate public policy of foreign governments? Oh, wait, the USG, all three branches, have expanded the roles of commercial interests in influencing public policy. I'm sure this will work out fine.

It seems the train has already left the station and I am on the back of the train.
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Anonymous Coward, 3 Jul 2014 @ 2:33am

Mike Masnick just hates it when copyright law is enforced.
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Anonymous Coward, 3 Jul 2014 @ 2:42am

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.
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Anonymous Coward, 3 Jul 2014 @ 4:17am

Re:
This isn't enforcement, this is reckless endangerment.
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Who Cares (profile), 3 Jul 2014 @ 4:29am

uh
Citations to back up your claims please.
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Anonymous Coward, 3 Jul 2014 @ 4:33am

Re:
This is what you're reduced to, Whatever?
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Anonymous Coward, 3 Jul 2014 @ 4:47am

I hope it will be revealed that the drug industry isn't as bad as we fear

Hope all you want. They have no concept of good and bad. They exist to make money.
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Anonymous Coward, 3 Jul 2014 @ 4:58am

Nothing invokes confidence like subterfuge.
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Anonymous Coward, 3 Jul 2014 @ 5:03am

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.
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Anonymous Coward, 3 Jul 2014 @ 7:30am

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...
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Anonymous Coward, 3 Jul 2014 @ 7:43am

There's not much point in the safety tests if we can't know the results of those tests.

Perhaps the test results of a substance that is not currently on the market are a trade secret. But for one that is? The consumers have a right to know.
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Anonymous Coward, 3 Jul 2014 @ 7:44am

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.
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Anonymous Coward, 3 Jul 2014 @ 8:18am

Re: Re:
I'm sure his post was sarcasm. Well played too.
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Anonymous Coward, 3 Jul 2014 @ 8:43am

Re: Re: Re:
Doubt it. average_joe and his usual gaggle of fanboys are really that brain-dead.
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Anonymous Anonymous Coward, 3 Jul 2014 @ 9:08am

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)?
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Anonymous Coward, 3 Jul 2014 @ 9:59am

'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?
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ECA (profile), 3 Jul 2014 @ 12:41pm

uMMM
FREE TRADE??
OPEN competition??
RESTRICTED market products??
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Big Al, 3 Jul 2014 @ 5:17pm

Re:
"Health and safety is supposed to come before profits."

Hahahahahahahahahahahahahah...(pause to catch breath)...Hahahahahahahahahahahahahah
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Anonymous Coward, 3 Jul 2014 @ 5:54pm

Privacy
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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Anonymous Coward, 4 Jul 2014 @ 5:49am

Re:
I hope it to be the case but I don't believe it. Same as I hope that one day we will be free of war, but I don't believe it will happen unless we are all dead.
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