India, TRIPS, TRIPS+, and new paradigms
by James Packard Love
India is now engaged in a debate over the appropriate implementation of Article 39.3 of the TRIPS. The Indian government is proposing a nuanced system that combines exclusive rights to rely upon data, combined with a set of limitations and exceptions to those rights. Although not public yet, the outlines of the proposal have been widely reported. In some of these reports, the government will allow generic competitors to use data for drug registration if they contribute to the costs of the data. The procedures and standards for determining remuneration do not appear to be established at this time.
Much of the criticism about the Indian government's proposals focuses on the fact that they exceed the obligations of the TRIPS agreement. Of course they do. Indeed, virtually every intellectual property regime we have ever looked at can be described as TRIPS plus, if not in the area of data protection, certainly in the areas of patent, copyright or plant varieties protection. The TRIPS agreement contains many areas where protection can be narrowed and limited, and few countries come close to taking full advantage of this.
We think it is a mistake for critics of the Indian government proposals to reject the steps toward a system of remuneration for use of test data. First, consider the political realities. No country that has engaged in serious bilateral negotiations on the data issue with the US or the EU has been able to maintain a system of no economic rights in the data. If this were not the case, we would join those who lobby exclusively for a minimalist implementation of Article 39.3 -- a position we think is entirely justified on policy and fairness grounds. But for now there is no evidence that hard-line positions, however meritorious on moral or policy grounds, are working.
What India is considering is a something new -- a system that would implement data protection as a right of remuneration in what appears to be a wide set of cases, including not only important cases like drugs for AIDS, but for any case where it is unethical to repeat clinical testing. Public health groups should be focusing on the implementation of the new remuneration right -- rather than opposing it.
The implementation (of 39.3) should avoid as much as possible any notion of exclusive rights to rely upon data, and to provide for limited remuneration rights in a set of narrow circumstances, such as the first approval of a new molecular entity (NME).[1]
Critics of a compensatory liability/remuneration right approach correctly point out that such an approach can be combined with complicated and onerous procedures, with that excessive remuneration could be a burden on the poor. This is of course one possibility. A different possibility is that India could implement remuneration rights with simple procedures and quite reasonable levels of remuneration. Public health groups should focus on the second possibility -- and not act as if there are no good ways to implement remuneration rights.
Any remuneration right for data is TRIPS plus, and WTO members have plenty of flexibility in determining how to approach this. For example, the US government provides for no appeals of remuneration decisions in its regime for cost sharing on agricultural data. India could take a similar approach for test data, narrowing or eliminating injunctions or appeals, or providing than any review of remuneration could only provide for forward looking changes.
Indian could embrace a system of cost sharing, along the lines that we have advocated elsewhere, or it could provide for a simple (low) royalty on product sales. There is no reason to design a system that would not work. [2]
In 1999, Rob Weissman and I drafted section 601 in the Hope for Africa bill. It sought to restraint the US government from calling for TRIPS plus rules in Africa.
No TRIPS+ was, in 1999, a very successful campaign. By May 10, 2000, President Clinton signed Executive Order 13155, "Access to HIV/AIDS Pharmaceuticals and Medical Technologies", and on November 14, 2001, the WTO adopted the Doha Declaration on TRIPS and Public Health, which called upon countries to use the full flexibilities of the TRIPS to protect access to medicine for all.
Since 2001, things have gotten much tougher. One only needs read the depressing text the many US/EU/FTA agreements concluded in the past four years, and to look at various WTO accession agreements, if not the US's unilateral 301 list and NTE reports.
In the short run, public health groups have to choose their battles. We are focusing on the US's proposals for (1) drug registration-patent linkage, (2) protection of test data, and (3) remuneration on compulsory licenses as the three key intellectual property issues. We are not taking a hard line on the test data issue. We are asking countries to implement systems of limited remuneration rights/compensatory liability, and opposing exclusive rights. We think this is achievable. We also think we can win in the US Congress on limiting bad FTA provisions on linkage or compulsory licensing remuneration.
There is plenty to room for countries to improve systems for non-voluntary licensing of patents or data. Important in this regard would more attention to models for the collective management of intellectual property rights, such as variations on the proposed patent pool for essential medicines. This can greatly enhance the capacity to utilize various compulsory licensing options.
In the longer term, we are looking to new paradigms, to restore public health priorities. One is to push for R&D treaties/agreements to replace trade agreements on IP or drug prices. Another is to push the notion of prizes linked to health outcomes as a replacement for marketing monopolies, as the chief "pull" incentive for drug development. We think these ideas are also achievable, and hugely important. They are also quite relevant and appealing for India, a country that seeks to reconcile its dual role as a home to hundreds of millions of very poor persons, and a growing high technology biomedicine industry.
The attempt to separate the markets for innovation from the markets for medicines is the longer and more sustainable strategy for fairness. We can and should make the point, loud and clear, that it is a mistake to link R&D incentives to the prices of medicines. The markets for the products (medicines and vaccines) should be competitive, driving prices toward marginal costs. But there can be new mechanisms (such as the prize fund approach) to reward innovations that improve health care outcomes. This big idea needs greater buy-in from health care advocates.
Notes:
[1] The current government proposals reportedly start with a notion of exclusive rights, and then provide for exceptions. This could be changed, so that non-voluntary use of the data would always be possible, subject in some cases to remuneration.
[2] See: May 18, 2006. Judit Rius Sanjuan, James Love & Robert Weissman. "A cost sharing model to protect investments in pharmaceutical test data." CPTech Policy Brief No. 1.
India is now engaged in a debate over the appropriate implementation of Article 39.3 of the TRIPS. The Indian government is proposing a nuanced system that combines exclusive rights to rely upon data, combined with a set of limitations and exceptions to those rights. Although not public yet, the outlines of the proposal have been widely reported. In some of these reports, the government will allow generic competitors to use data for drug registration if they contribute to the costs of the data. The procedures and standards for determining remuneration do not appear to be established at this time.
Much of the criticism about the Indian government's proposals focuses on the fact that they exceed the obligations of the TRIPS agreement. Of course they do. Indeed, virtually every intellectual property regime we have ever looked at can be described as TRIPS plus, if not in the area of data protection, certainly in the areas of patent, copyright or plant varieties protection. The TRIPS agreement contains many areas where protection can be narrowed and limited, and few countries come close to taking full advantage of this.
We think it is a mistake for critics of the Indian government proposals to reject the steps toward a system of remuneration for use of test data. First, consider the political realities. No country that has engaged in serious bilateral negotiations on the data issue with the US or the EU has been able to maintain a system of no economic rights in the data. If this were not the case, we would join those who lobby exclusively for a minimalist implementation of Article 39.3 -- a position we think is entirely justified on policy and fairness grounds. But for now there is no evidence that hard-line positions, however meritorious on moral or policy grounds, are working.
What India is considering is a something new -- a system that would implement data protection as a right of remuneration in what appears to be a wide set of cases, including not only important cases like drugs for AIDS, but for any case where it is unethical to repeat clinical testing. Public health groups should be focusing on the implementation of the new remuneration right -- rather than opposing it.
The implementation (of 39.3) should avoid as much as possible any notion of exclusive rights to rely upon data, and to provide for limited remuneration rights in a set of narrow circumstances, such as the first approval of a new molecular entity (NME).[1]
Critics of a compensatory liability/remuneration right approach correctly point out that such an approach can be combined with complicated and onerous procedures, with that excessive remuneration could be a burden on the poor. This is of course one possibility. A different possibility is that India could implement remuneration rights with simple procedures and quite reasonable levels of remuneration. Public health groups should focus on the second possibility -- and not act as if there are no good ways to implement remuneration rights.
Any remuneration right for data is TRIPS plus, and WTO members have plenty of flexibility in determining how to approach this. For example, the US government provides for no appeals of remuneration decisions in its regime for cost sharing on agricultural data. India could take a similar approach for test data, narrowing or eliminating injunctions or appeals, or providing than any review of remuneration could only provide for forward looking changes.
Indian could embrace a system of cost sharing, along the lines that we have advocated elsewhere, or it could provide for a simple (low) royalty on product sales. There is no reason to design a system that would not work. [2]
In 1999, Rob Weissman and I drafted section 601 in the Hope for Africa bill. It sought to restraint the US government from calling for TRIPS plus rules in Africa.
HR 772. Sec. 601 Requirements Relating to Sub-Saharan AfricaThis proposal was criticized by some in 1999, because Rob and I appeared to be endorsing the TRIPS agreement, which was controversial then. But Rob and I had decided that we could win a no-TRIPS plus approach at that time, and not a no TRIPS approach. We never endorsed the TRIPS. We just asked the Congress to stop the executive branch from going further than TRIPS, in Sub-Saharan Africa.
Intellectual Property and Competition Law
Funds appropriated or otherwise made available to any department or agency of the United States may not be used to seek, though negotiation or otherwise, the revocation or revisions of any sub-Saharan African intellectual property or competition law or policy that is designed to promote access to pharmaceuticals or other medical technologies and such law or policy, as the case may be, complies with the Agreement on Trade-Related Aspects of Intellectual Property Rights referred to in section 101(d)(15) of the Uruguay Round Agreements Act.
No TRIPS+ was, in 1999, a very successful campaign. By May 10, 2000, President Clinton signed Executive Order 13155, "Access to HIV/AIDS Pharmaceuticals and Medical Technologies", and on November 14, 2001, the WTO adopted the Doha Declaration on TRIPS and Public Health, which called upon countries to use the full flexibilities of the TRIPS to protect access to medicine for all.
Since 2001, things have gotten much tougher. One only needs read the depressing text the many US/EU/FTA agreements concluded in the past four years, and to look at various WTO accession agreements, if not the US's unilateral 301 list and NTE reports.
In the short run, public health groups have to choose their battles. We are focusing on the US's proposals for (1) drug registration-patent linkage, (2) protection of test data, and (3) remuneration on compulsory licenses as the three key intellectual property issues. We are not taking a hard line on the test data issue. We are asking countries to implement systems of limited remuneration rights/compensatory liability, and opposing exclusive rights. We think this is achievable. We also think we can win in the US Congress on limiting bad FTA provisions on linkage or compulsory licensing remuneration.
There is plenty to room for countries to improve systems for non-voluntary licensing of patents or data. Important in this regard would more attention to models for the collective management of intellectual property rights, such as variations on the proposed patent pool for essential medicines. This can greatly enhance the capacity to utilize various compulsory licensing options.
In the longer term, we are looking to new paradigms, to restore public health priorities. One is to push for R&D treaties/agreements to replace trade agreements on IP or drug prices. Another is to push the notion of prizes linked to health outcomes as a replacement for marketing monopolies, as the chief "pull" incentive for drug development. We think these ideas are also achievable, and hugely important. They are also quite relevant and appealing for India, a country that seeks to reconcile its dual role as a home to hundreds of millions of very poor persons, and a growing high technology biomedicine industry.
The attempt to separate the markets for innovation from the markets for medicines is the longer and more sustainable strategy for fairness. We can and should make the point, loud and clear, that it is a mistake to link R&D incentives to the prices of medicines. The markets for the products (medicines and vaccines) should be competitive, driving prices toward marginal costs. But there can be new mechanisms (such as the prize fund approach) to reward innovations that improve health care outcomes. This big idea needs greater buy-in from health care advocates.
Notes:
[1] The current government proposals reportedly start with a notion of exclusive rights, and then provide for exceptions. This could be changed, so that non-voluntary use of the data would always be possible, subject in some cases to remuneration.
[2] See: May 18, 2006. Judit Rius Sanjuan, James Love & Robert Weissman. "A cost sharing model to protect investments in pharmaceutical test data." CPTech Policy Brief No. 1.
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