except where necessary to protect the public…

Posted on Wednesday 11 June 2014

This is how Trudo Lemmons ended his commentary on the recent EMA U Turn on Data Transparency [see a crushing setback…, repeal the proprietary data act…]:
EMA’s Proposed Data Release Policy
PLoS Blogs
By Trudo Lemmens
May 30, 2014

In short, EMA’s approach is strengthening industry’s legal control over data, making it more difficult and legally risky for independent scientists to use them. These are in essence regulatory data, created for public interest use. For the EMA, a key public institution, to now support the privatizing of pharmaceutical knowledge through contractual affirmations of companies’ rights over these data is truly astounding. Dr. Rasi’s recent response to the Ombudsman, that EMA’s new policy is a ‘reasonable compromise’, and does not prevent researchers from asking for access to specific data sets on the basis of the existing access to information policy, does not reassure. His response does not recognize the legal concerns raised by the draft TOU and Redaction Principles, let alone justify the approach taken. And Abbvie’s withdrawal of the legal challenge of the Humira data release notwithstanding, EMA appears back in the business of imposing more extensive limits on what it gives access to in response to specific access requests.

This troubling development is not entirely surprising. Even if the transparency movement had some major victories, including the adoption of transparency requirements in the recent European Clinical Trials Regulation, opposition has been mounting. Industry may now employ other regulatory initiatives to fight transparency. The European commission recently released a draft directive aimed at streamlining and strengthening Trade Secret protection in Europe. The European Federation of Pharmaceutical Industries and Associations [EFPIA] jumped already enthusiastically on the occasion, emphasizing the need to protect the “proprietary know-how” of drug development, including in the “clinical trials phase”. In the context of ongoing and largely secret transatlantic trade negotiations between Europe and the United States and Canada, the pharmaceutical industry has also been lobbying hard to strengthen data and IP protection and to include better data protection in the package. EMA now appears to be lending a helping hand.
Note his emphasis on Trade Agreements. I gather that this is what PHARMA uses to justify treating Clinical Trial data as proprietary. This is a recent article, written before the U Turn:
by Pamela Andanda
IIC – International Review of Intellectual Property and Competition Law. 2013 44[2]:140-177.

The nature and scope of intellectual property protection, if any, which clinical trial data should receive in terms of Art. 39 of the TRIPS Agreement have been put back in the spotlight through recent events: First through suggestions by heads of the Dutch, French and UK regulatory authorities as well as the European Medicines Agency that such data should not be considered commercially confidential information. Secondly, courts in countries such as Argentina and Brazil have recently decided cases in which they had to balance rights over clinical trial data with competing public health priorities. Both courts decided that public health interests take priority over claims for exclusive rights over clinical trial data. These events raise pertinent ethical and legal concerns, which warrant considerations of strategies that can be used to manage intellectual property rights over clinical trial data with a view to fostering access and benefit sharing in public health. This paper draws lessons from these events and suggests possible options for strategic management of intellectual property rights over clinical trial data in order to cater to public health needs. The concept of access and benefit sharing, which has so far been debated in the fields of biodiversity and most recently in the human genome context is applied to public health with a view to initiating discussions on how it can inform decision making in the management of intellectual property rights over clinical trial data.
hat tip to arby… 
Referencing this Trade Agreement [World Trade Organization]:
PART II — Standards concerning the availability, scope and use of Intellectual Property Rights
Article 39

1. In the course of ensuring effective protection against unfair competition as provided in Article 10bis of the Paris Convention [1967], Members shall protect undisclosed information in accordance with paragraph 2 and data submitted to governments or governmental agencies in accordance with paragraph 3.

2. Natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to, acquired by, or used by others without their consent in a manner contrary to honest commercial practices [10] so long as such information:
    [a] is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question;
    [b] has commercial value because it is secret; and
    [c] has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret.
3. Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.
I call bullshit on two grounds. There’s nothing in the raw data that is a Trade Secret or of commercial significance [unless you consider keeping secret that the drug doesn’t much work of commercial significance]. Second, making this information available is definitely "necessary to protect the public." I’m obviously not a person to mess with World Trade Organization agreements or International Intellectual Property law, so I pass these references on to anyone who is so inclined…
    Steve Lucas
    June 11, 2014 | 8:33 AM
    June 11, 2014 | 3:19 PM

    Of course lack of efficacy is commercially significant, as is adverse event detail.

    Regulatory organizations are sensitive to the need of pharmaceutical companies to make unfounded claims about their products in order to be profitable and continue to be in business. They’re all in it together to keep business humming. Injured people are just so much roadkill.

    June 11, 2014 | 3:21 PM

    Oh, forgot to add — in the “religion of the free market” worldview, keeping business humming despite incidental roadkill is in the interest of the greater good, so it does protect the public job-wise, investment-wise, etc.

    June 12, 2014 | 11:18 AM

    Depending on the perceived threat, any law or statute at their disposal even if it only marginally applies is fair game for setting precedents in their favor. I expect we’ll see the game of whack-a-mole continue for some time.

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