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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Filed Under: european union, patents, pharmaceuticals, special 301 report, ustr
Companies: phrma
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We're on the Special 301 Report
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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.
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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.
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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!
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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!
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But, but, but -- the NSA tells us that metadata is harmless. They surely wouldn't lie, would they?
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Confidence. in their business.
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When it seems the whole world is out to get you, chances are that you're on the wrong side to begin with.
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They already have 6 to 13 years of protection for this data in the EU
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.
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"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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Refrain from doing so immediately before you harm yourself!
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Headline is incorrect
FTFY, Glyn.
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