I’m not sure what all this means, but I’m pretty sure it’s not good news, a decided blow to Data Transparency. I’ve e-mailed everyone I know who might be able to clarify…
Trade Secrets Directive opens the way for shady TTIP negotiationsepha14 April 2016Brussels, 14 April 2016. The European Parliament approved today a new Directive on Trade Secrets, a position that would signal that trade secrets outweigh the public interest. The impact will be negative for health, by declaring information on safety of medicines commercially confidential and to be kept secret from patients, regulators and the public. The Trade Secrets Law would gag journalists and whistle-blowers, undermining freedom of expression and preventing vital information reaching the media and public. With regard to public health, the new rules would erect a barrier to public access to data on the safety and efficacy of medicines.
As a result, Europe could soon be stripped of its hard-won global leader position on clinical trials transparency. The proposals for the Trade Secrets Directive are clearly intended to increase commercial confidentiality in the interest of drug makers who seek to keep clinical trials results secret, and would weaken patient safety protection and halt further research and independent analyses. The worrying lack of legal guarantees preventing companies from abusing the concept of trade secrets opens the way for unethical repetition of clinical trials on people, and the injection of public resources spent on therapies that are no better than existing treatments, do not work, or do more harm than good.
“This vote weakens recent efforts by European Institutions to increase sharing and transparency of essential health data. Clinical trials data transparency is key for patient safety, for access to affordable medicines, for public health research and innovation.” stated Nina Renshaw, Secretary General of the European Public Health Alliance. “Today’s vote is clearly designed to undermine the Clinical Trials Regulation, on which the ink is barely dry, which was huge progress for patient safety and access to medicines, but has always been opposed by the pharmaceutical industry which prefers to conduct trials in secrecy. It also seems to be aiming at smoothing the way for the pharmaceutical industry in the EU-US TTIP negotiations, and would lower transparency requirements in the EU to be closer in line with much weaker rules in the US.”Today’s vote creates dangerous uncertainty around the issue of trade secrets, particularly for medicines. It opens the way for pharmaceutical companies to use and abuse this Trade Secrets Directive, leaving only rulings from the European Court of Justice to determine the outcome and judgement of future litigations on a case-by-case basis. The Council of the EU will vote on this Directive on 26 May -a vote that will likely be in line with the Parliament’s stance…
Intellectual Property Watchby Dugie Standeford14/04/2016
Rejecting calls for a vote to be delayed until the European Commission proposes tougher whistle-blower protections, the European Parliament on 14 April approved by 503-131 new rules giving companies redress for theft or misuse of trade secrets. Debate on the trade secrets directive showed sharp divisions among lawmakers, heightened by the recent “Panama Papers” and other leaks, over whether the legislation will help businesses safeguard their innovative ideas or lead to increased corporate secrecy…
Yeah, this is what I was afraid of. Damn.
“Con”-fluence of interests…,
Really too bad, but only severe wishful thinking should be surprised. Data transparency faces almost insuperable legal barriers in the States because of the interwoven State and Federal “Trade Secrets” acts.
This attempts to gain a similar European situation ,or worse ,given gag restrictions.Plainly the only immediate hope lies in a mass negative civc and political response prior to the EU Council Meeting on 5/26.Left wing governments as in France should able to arouse popular rejection. Popular politically astute journalists,such as Ben Goldacre , must have seen this coming Hopefully some countervailing pressure is in place.
Don Klein
Dr. Klein, guess I had severe wishful thinking. But you are likely correct. I do wish that that mass negative response, if it materializes, will likely be largely in the absence of physician, particularly psychiatrist, participation. For me to think otherwise would be the apogee of wishful thinking?
Paragraph 10(a) of the Directive sounds good.”Furthermore, the acquisition, use or disclosure of trade secrets, whenever imposed or permitted by law should not be treated as unlawful. As a result, the acquisition or disclosure of a trade secret by administrative or judicial authorities for the performance of their duties should be lawful.”, but what it means in application is unclear.
Discussion of the impact of the law on Regulatory Authorities is missing. The nominal thrust of the Directive is “Harmonization” since some States have insufficient protection.
Don Klein
Mousing around the EPHA i stumbled on the TTIP . How many know of this? It’s the Transatlantic Trade and Investment Partnership (TTIP) trade negotiations between the EU and US deals with ’Regulatory Cooperation’.
EPHA states
“Whilst it may sound dull and harmless it poses and extremely serious threat to national governments’ right to regulate, for example to protect public health, consumer rights, workers or the environment. EPHA emphasizes the need to defend governments’ and the EU’s right to legislate and set policies to address today’s major public health challenges posed by chronic diseases, overweight and obesity, antibiotic resistance and access to medicines and healthcare” . Harmonization is going TransAtlantic..
Don Klein
Don,
I’ve been trying to figure out what TTIP really is for a while, and it’d beyond my faculties. I wrote all the Europeans of like mind, but I haven’t heard back. I’ve been at it for a few days with zero results. Thanks for running it down. I hope someone will be forthcoming with details soon.
Mickey
TTIP are negotiated in secret between governments, in and outside EU, and the US. Norwegian parliamentarians are in general ignorant of the ramifications, as are most Europeans, politicans and civilians. What is known comes mainly from leaks. It’s conducted in secret. It’s less about tariffs, mostly about governments guaranteeing huge corporations against present/ future laws and regulations that may be detrimental to profits on investments – opening a way they can sue for loss of profit on account of democratic, national law and regulation. What’s called harmonization will open Europe to the weakest laws and regulations as practiced in the USA. New policies and law will be negotiated via huge lobbying consultanties – controlled by global/US corporations. It’s said here among protesters that Big Pharma is a heavy – maybe the heaviest – participator in scripting the secret play.
Good site which I suspect 1BOM may know.
http://www.epha.org/a/6498
http://www.alltrials.net/news/phrma-claims-transparency-risks-damaging-public-health/
https://mobile.twitter.com/bengoldacre/status/530085571532967936
The memo referenced here may be informative?
http://www.politico.com/tipsheets/morning-trade/2016/04/administration-makes-a-tpp-pharma-sales-pitch-pritzker-businesses-raring-to-go-on-tpp-froman-starts-week-in-london-with-ttip-213686
Berit,
I do know epha. I keep hoping they’ll post more about the specifics of this recent vote. If you run across something, let us know.
1bym,
Yeah, I keep finding things that worry in advance. But it looks like “in advance” will soon pass and I can’t find anything yet about where we are now. As Don mentions, it sounds like we could use a revolution sometime before the May 26th definitive vote. I wonder if this will tip the scales towards the BREXIT movement [England leaving the EU – BRitish EXIT]…
http://www.independent.co.uk/voices/comment/what-is-ttip-and-six-reasons-why-the-answer-should-scare-you-9779688.html
https://stop-ttip.org/
https://stop-ttip.org/material-list-for-information-on-ttip-ceta-tisa/
https://stop-ttip.org/blog/trade-negotiators-vs-legal-experts/
So basically it’s international fascism. By definition.
As best I can tell, the TTIP is the European cousin of the TPP (Trans-Pacific Partnership) proposed for the US, Canada and a group of Pacific Rim and Latin American countries: Australia, New Zealand, Chile, Mexico, Peru, Japan, Vietnam, Brunei, Maylasia, Singapore.
You may have heard the TPP referred to as NAFTA on Steroids. Actually, it’s worse than that. It’s only partly about lowering trade barriers as such (tariffs, etc.) Mostly what it’s about is “investor-state dispute resolution” systems that beef up intellectual property rights, and give foreign investors the right to challenge any action by a member state that interferes with their expected return on investment. Pharmaceuticals are a HUGE part of this agreement, and the aim is to torpedo every law that restrains the price of drugs or limits the eternal sunshine of their patent rights. (Software and IT giants want similar provisions.)
The TTIP is very similar. For the most part we do not hear much about it because the balance of fear is tipped in the European direction — they fear being dragged down to our level of savage capitalism. (As opposed to the TPP which scares everybody.) Here’s a column on the TTIP we ran on RxISK about 18 months ago. The immediate threat it refers to (transferring EU drug regulation to the Department of Trade) has passed, but just about everything else is still on the table:
http://rxisk.org/medicines-are-not-just-a-commodity/
At the time we warned of the EU possibly losing its right to reject crappy and/or risky American drugs. Unfortunately the EU has since started approving more of said crap drugs … the race to the bottom is on, before the TTIP is signed:
http://rxisk.org/the-show-aint-over-till-the-fat-lady-sings/
Not an overstatement:
http://neweconomicperspectives.org/2015/05/tpp-the-fascism-issue.html
When having the power to write legislation through lobbying isn’t enough.