PhRMA Wants EU Put On US's 'Priority Watch List' For Plans To Disclose Basic Safety Info About Drugs

from the yeah,-that's-reasonable dept

We’ve written many times about how the USTR uses its Special 301 Report to bully smaller countries into toeing the US line. One of the most influential organizations providing input into who should sit on this year’s naughty step is PhRMA, the Pharmaceutical Research and Manufacturers of America. James Love points out that its submission this year is notable for the following demand:

PhRMA requests that the EU be placed on the Priority Watch List for the 2014 Special 301 Report, and that the U.S. Government continue to seek assurances that the problems described herein are quickly and effectively resolved.

The European Union is accused of three basic sins, including ineffective patent enforcement — rather implausible given Europe’s extremely strong patent regime in this area — and daring to take into account the cost of relevant generics when setting medicine prices. But the most interesting complaint is the following:

EMA data disclosure policy: PhRMA and its member companies are very concerned that current practices of the European Medicines Agency (EMA) and proposals being advanced through the EMA and the European parliament to provide virtually unrestricted access to and publication of biopharmaceutical companies’ clinical trial regulatory submissions and data will substantially harm patient privacy, the integrity of the regulatory system, and incentives for pharmaceutical research and development. Failing to protect confidential commercial information contained in regulatory submissions is inconsistent with the EU’s treaty obligations contained in the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and primarily benefits competitors who wish to free-ride off of the investments of innovators. We are especially concerned that proposals to disclose regulatory clinical study reports (CSRs) in their entirety — a class of document that the EMA has traditionally considered to be commercially confidential information — will allow competitors to submit innovators’ documents to gain regulatory approval in non-European countries.

Techdirt wrote about the EMA’s plans to make clinical trials data for drugs available (including the key clinical study reports) back in November. As that post explained, this is basic safety data — not “confidential commercial information” as PhRMA claims in its Special 301 submission. These are simply the scientific facts about a drug that establish what side effects it has, and whether it offers sufficient benefits to be approved for sale.

Drug companies that are confident their products are safe should welcome the opportunity to prove that in a completely transparent manner, and to benefit themselves in multiple ways from this general opening-up. PhRMA’s desperate attempt to get the USTR to interfere with the European Union’s plans would suggest that some of its members may have something to hide — a view that recent scandals involving big pharma tend to support.

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Comments on “PhRMA Wants EU Put On US's 'Priority Watch List' For Plans To Disclose Basic Safety Info About Drugs”

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Anonymous Coward says:

and dont forget that the option of companies being able to sue countries/governments is to be/has been removed from TPP, thank goodness, and hopefully will never be brought back in for this or any other USA-only focused ‘Trade Deal’! like all USA companies and industries, they want it all but want to give back nothing! with luck, the EU will tell them to go fuck themselves!

Kronomex (profile) says:

I’m hoping the EU crushes this vile behaviour by overbearing, thuggish, cowardly actions by hiding behind their puppets in government, and increasingly greedy corporations in the US. The sad part is that out feds here will probably sign the TPP AND then tell the Australian population what a great thing they’ve done. Then again, I’m not holding my breath, they might grow a pair and tell the corporations where they can go.

Anonymous Coward says:

Clinical trial data should not be confidential. The individual people in the trial should be, yes. But not the aggregate data. People should have a right to know how safe the drug is that they are taking.

Even if the results are unfavorable and the drug does NOT get put up for sale the data should be available, for two reasons. First, it will allow doctors to better treat any patients who were in the trial and experienced side effects. Second, it will help other drug companies to develop their own drugs. This is not a negative if all the drug companies are doing it – and it will not benefit those drugmakers that only make generics and don’t do any research anyway.

That One Guy (profile) says:

Re: Re:

‘Even if the results are unfavorable and the drug does NOT get put up for sale the data should be available-‘

I’d argue that the results being unfavorable, and the drug not being put up for sale would increase the importance of the data being released, as it would help both doctors and medical researchers know what to avoid in the future.

Anonymous Coward says:

Re: Re: Re:

I agree. It has been a tradition in science to treat negative results and failed experiments as embarrassing.

In reality narrowing the experimental parameters is one of the most basic parts of practical science and failed experiments are thus just as important as what seems like successes in that they provide vital clues for further evaluations on the subject.

What I am saying is that it isn’t just a problem in private companies to treat “failures” as embarrassments. It is a culture that needs to change among many kinds of scientists!

Anonymous Coward says:

The patient confidentiality is always going to be an issue through meta-analysis. Even though names are redacted, the people participating will often be identifiable if enough meta-data exists. It is not usually recognized politically, but as more meta-data analysis happens it becomes an inevitable threat to any expectation of privacy. Still, it should not be an argument for not releasing the reports. Any trials involving human subjects has this potential and science has a need for analyzing these kinds of data!

I don’t understand the “integrity of regulations”. It sounds like a corporate world governance move to demand changes to legislation just because laws are unclear or in conflict with other laws. These things have been the case with laws for centuries. As long as the background for the law is publically available it should not be that problematic legally.

The incentive is a tricky piece, but overall their argument seems to hinge on the threat of other companies stealing patents, in other jurisdictions. IIRC there is already a delay on when these documents are released. As long as that delay is long enough, this is not a problem!

There may be some arguments in there to look at exceptions and numbers, but they are not arguments that weakens the premise for the legislations at all!

Capt ICE Enforcer says:

Confidence. in their business.

The drug companies are confident their drugs are not safe. Why would they care about the safety of their consumers. They make money from sick people, not healthy. Take this drug to fix headaches but cause nausea. So you take this other drug to help with nausea but makes it hard to sleep, take another pill to help sleep but causes dthe poops so take another pill to fix that but causes headaches. Drug companies make 6x profit by giving more illness than help. They make the cash then pay out a settlement to lawyers when they get caught.

Gabriel J. Michael (profile) says:

They already have 6 to 13 years of protection for this data in the EU

I was confused at first, because clinical trial data is already protected for at least 10 years in the majority of EU member states. Note that this is longer than the 5 years protection in the US, so it’s funny that US firms are complaining.

But then I read carefully:

“We are especially concerned that proposals to disclose regulatory clinical study reports (CSRs) in their entirety… will allow competitors to submit innovators’ documents to gain regulatory approval in non-European countries.”

Basically they want to prevent generic firms from relying on clinical trial data ANYWHERE IN THE WORLD, not just where such reliance is prohibited by law.

Anonymous Coward says:

How da fuk, does

“Failing to protect confidential commercial information”

“will substantially harm patient privacy”

Can someone s’plain, because to me it looks like their making up a bullshit excuse, i.e. LYING, about one thing so that they can pass another thing, and that other thing being rightly questionable

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