Hatch Still Trying To Change The Finalized TPP Deal To Make It Even Worse For Other Nations

from the two-edged-sword dept

As Techdirt noted in 2014, by agreeing to the "fast track" procedure for trade deals, Congress has essentially given up its power to change them. That's a two-edged sword. Although it makes the ratification process simpler, because things like TPP and TTIP must be accepted or rejected in their entirety, it also means that political bosses have no ability to tweak the text to make it more likely the deals will be ratified. That's coming back to bite one of the people who introduced the fast track bill, Senate Finance Committee Chairman Orrin Hatch.

He has been trying for a while to get TPP to require the same 12 years' monopoly of drug safety data that the US provides for so-called "biologic drugs," in addition to the normal patent protection they enjoy. The final TPP text specifies eight years, and because of the fast track authority that he worked so hard to put in place, there is no way for Hatch to get the text changed now that it has been finalized. According to a report from Bloomberg, Hatch is apparently hoping that "binding side agreements" with the other TPP nations might do the trick, but there's a problem with that or any similar approach:

Australia, New Zealand and Peru have all indicated at various points during the last six months that they will not change their positions concerning biologics and stand by the agreed-upon language contained in the TPP.

"I don't know what they're going to offer, but they know I'm at 12 years of data exclusivity,” he said of the administration. "They're going to have to find a way of having the countries agree to change that formality in the TPP to 12 years or come up with something that will be acceptable."

That's really pretty extraordinary. After nearly eight years of tough negotiations, concessions were made and a final text agreed by all the countries involved. And now Hatch says it's not good enough, that the US has some special right to ask for yet more, and that countries refusing to up their protection for biologics data to 12 years won't be part of the TPP deal. Understandably, some in those nations at risk of being thrown out of TPP are unhappy about this threat. For example, Dr. Patricia Ranald, Convener of the Australian Fair Trade and Investment Network, said:

"The extra three years of monopoly [beyond current Australian regulations] in the current TPP text is already unacceptable. It is outrageous that the US is demanding an even greater increase from 8 to 12 years. We call on the Australian and other governments to reject this proposal."

In fact, it's even worse than that. As we pointed out a year ago, granting any protection to the clinical trial data used to gain approval for biologics seriously undermines one of the fundamental principles of science: that basic facts cannot be owned, and that progress is made by building on the results of others. Hatch is right that the eight-year term of protection for biologics data in TPP is unacceptable, but he's wrong about what the right term would be: it's not 12 years, but zero.

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Filed Under: australia, biologics, data exclusivity, orrin hatch, tpp

Medical Researchers Want Up To Five Years Exclusivity For Clinical Trial Data Derived From Volunteers

from the papers-before-patients dept

A year ago, we wrote about how TPP's requirement for "data exclusivity" risked undermining one of science's fundamental principles: that facts cannot be owned. Data exclusivity is just the latest attempt by Big Pharma to extend its monopoly over drugs, whether using patents or other means. To a certain extent, you might expect that: after all, companies are designed to maximize profits, and if it means more people suffer or die along the way, well, that's regrettable but sort of beside the point. However, it's surprising to see a group of medical researchers writing in the prestigious New England Journal of Medicine (NEJM) calling for just the same kind of data exclusivity. The post is in response to an earlier NEJM article by the International Committee of Medical Journal Editors (ICMJE), entitled "Sharing Clinical Trial Data":

As a condition of consideration for publication of a clinical trial report in our member journals, the ICMJE proposes to require authors to share with others the deidentified individual-patient data (IPD) underlying the results presented in the article (including tables, figures, and appendices or supplementary material) no later than 6 months after publication.

Reasonable enough, you might think. But in the new commentary from the International Consortium of Investigators for Fairness in Trial Data Sharing -- which doesn't seem to have any online presence currently -- a group of "282 investigators in 33 countries" (pdf) beg to differ:

Although we believe there are potential benefits to sharing data (e.g., occasional new discoveries), we believe there are also risks (e.g., misleading or inaccurate analyses and analyses aimed at unfairly discrediting or undermining the original publication) and opportunity costs (e.g., the ICMJE proposal would have enormous direct costs and would probably divert resources, both financial and human, from the actual conduct of trials).

It's rather telling that the new discoveries that arise from research are dismissed as "occasional," while the rather weird concern about "discrediting or undermining the original publication" is put forward as if it were a major problem in the field. The International Consortium of Investigators for Fairness in Trial Data Sharing has a few suggestions for what should be done instead of the ICMJE proposal:

The timeline for providing deidentified individual patient data should allow a minimum of 2 years after the first publication of the results and an additional 6 months for every year required to complete the study, up to a maximum of 5 years.

Five years' data exclusivity takes us into TPP territory. And then there's this:

Persons who were not involved in an investigator-initiated trial but want access to the data should financially compensate the original investigators for their efforts and investments in the trial and the costs of making the data available.

You may have thought research was about winning new knowledge and willingly sharing it with your peers, but in fact it's about money. Actually, what is most shocking about the International Consortium of Investigators for Fairness in Trial Data Sharing's opinion piece is not what it says, but what it doesn't say. The whole thrust of the piece is what a tough life researchers have:

To complete an RCT [randomized, controlled trial], investigators must develop a protocol, obtain funding, overcome regulatory and bureaucratic challenges, recruit and follow participants, undertake analyses, and publish the results. This process takes several years, and for large clinical trials it can sometimes take a decade or longer. Adequate incentives for researchers to invest the substantial time and effort required to conduct RCTs and to publish the results in a timely fashion are important.

But at least it's a noble struggle, you might think, since this is all done for the patients' benefit. Or maybe not:

A key motivation for investigators to conduct RCTs is the ability to publish not only the primary trial report, but also major secondary articles based on the trial data.

It's all about those career-enhancing publications, apparently. But it's not just the patients who are missing from the International Consortium of Investigators for Fairness in Trial Data Sharing's worldview. They are also ignoring an absolutely indispensable aspect of clinical trials. It's so important that the ICMJE's article begins by acknowledging it in the first sentence:

The International Committee of Medical Journal Editors (ICMJE) believes that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk.

This is why the data that results from those clinical trials must be shared as soon as possible: because members of the public who volunteer to take part in them have literally risked their lives in order to benefit others. The idea that this data should be hoarded by the researchers for up to five years just so that they can squeeze out a few more articles that look good on their CV is profoundly insulting to the participants and their unsung selflessness.

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Filed Under: clinical trials, data, data exclusivity, medical research

Why TPP Threatens To Undermine One Of The Fundamental Principles Of Science

from the and-that's-a-fact dept

Last week, we wrote that among the final obstacles to completing the TPP agreement was the issue of enhanced protection for drugs. More specifically, the fight is over an important new class of medicines called "biologics," which are produced from living organisms, and tend to be more complex and expensive to devise. The Conversation has a good feature looking at this issue in more detail. The central problem with biologics in TPP is "data exclusivity," which the article explains as follows:

Data exclusivity refers to the protection of clinical trial data submitted to regulatory agencies from use by competitors. It's a different type of monopoly protection to patents. While a product is covered by data exclusivity, manufacturers of cheaper follow-on versions of the product can't rely on the clinical trial data produced by the originator of the drug to support the marketing approval of their product.

Section 25a of Australia's Therapeutic Goods Act provides for five years of data exclusivity for all medicines. It makes no distinction between biologics and other drugs. Data exclusivity provides an absolute monopoly that, unlike a patent, can't be revoked or challenged in court.

As that makes clear, data exclusivity is a kind of super-patent in that it can't be challenged or revoked: if a drug company has run clinical trials to establish the safety of its new drug, it has an absolute and irrevocable monopoly on the use of that data -- for five years in the case of Australia, Chile, Singapore and New Zealand. This is obviously an incredibly powerful form of monopoly, so perhaps it's no surprise that US pharmaceutical companies want TPP to require signatories to grant an even longer period -- 12 years of data exclusivity -- for biologics.

That's useful for them, because even after drug patents have expired, and generic manufacturers can theoretically offer the same products without paying licensing fees, there remains the barrier of clinical testing. If the generic manufacturers can't point to the original clinical trials as proof that the drug is safe, they will need to carry out their own, which will take time and cost money. In practice, they are more likely to wait until the period of data exclusivity is over, effectively extending the original manufacturer's monopoly beyond that provided by patents alone.

So what? You might ask. Surely it's only fair that generic manufacturers cannot piggy-back on the work of the original drug companies? Although that argument sounds plausible, it overlooks the fact that what clinical trials produce is safety data about a drug, which is simply a certain kind of scientific fact concerning a particular complex compound, as unchanging as all its other features. It is not something that depends on the ingenuity of the person measuring it, because it represents intrinsic information about a substance. Granting data exclusivity is thus nothing less than giving a monopoly on knowledge itself, since it forbids any other company from being able to use that newly-established scientific fact.

That is a profoundly retrogressive step. Although dressed up in terms of fairness and recouping investments, the very notion of data exclusivity is an attack on the key idea that no one can own a scientific fact, and that science advances by building on existing knowledge. Arguments about whether the length of that monopoly should be five, eight or even twelve years, are not just pointless, they are pernicious, because any of them would lock the TPP countries into a system that allows basic facts to be owned, and would forbid them from exiting from it. The only acceptable length for data exclusivity is zero years; anything longer turns TPP into an attack on science itself.

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Filed Under: biologics, data, data exclusivity, science, sharing, tpp