On July 4th, 2017, Andrew Goldman delivered Knowledge Ecology International’s intervention on patents at health at the 26th session of the WIPO Standing Committee on the Law of Patents (SCP).
KEI Statement on Patents and Health
WIPO Standing Committee on the Law of Patents – 26th Session
July 4th, 2017
Since the African Group and Development Agenda Group first tabled their proposal on a work program on patents and health in May 2011, much has happened.
In the words of the delegation of Portugal at this year’s World Health Assembly,
All regions of the world face, at different levels, insufficient access to medical products. In recent times, the dramatic increase of prices of new and innovative medicines made them unaffordable to large segments of the population also in rich countries, while threatening the sustainability of health care systems. In too many countries, prices of new medicines (to treat Hepatitis C and cancer, for instance) are particularly shocking.
The sustainability of health systems is a constant concern and objective. However, it has been threatened by the exorbitant prices of some innovative medicines that make them inaccessible to large segments of the population.
The United States is among the many countries struggling to address high drug prices. On June 27, 2017, Dr. Scott Gottlieb, the head of the US FDA, said, “No patient should be priced out of the medicines they need, we must do our part to help patients get access to the treatments they require.” (https://twitter.com/SGottliebFDA/status/879705289590804487)
What needs to be done?
Feasibility study on delinkage
As noted by former UN Secretary Ban Ki-moon in appointing a High-Level Panel on Access to Medicines, the challenge to making drugs more affordable and access more equal and fair, is the “policy incoherence” between intellectual property rights, innovation, and affordable access to medicines. This includes but is not limited to policies that relate to patents.
At present, the primary global policy to induce investments in biomedical R&D is to grant a temporary monopoly on a medical invention, enabling the holder of a patent to charge high prices that undermine affordability and access. It is hardly surprising that one observes high prices and unequal access to medicines when high prices are the primary instrument to finance innovation.
A growing number of governments, policy experts and stakeholders are recognizing the need to change the current system, so that the financing of R&D, including the incentives to private investors, are progressively delinked from the prices of products.
To accomplish this delinking, governments and international norm setting organizations have to enhance and expand the role of mechanisms to fund R&D that do not rely upon high drug prices, and ensure that laws on patents and other intellectual property rights are consistent with such reforms.
In 2017, in the United States, 16 US Senators and 14 Members of the US House of Representatives have called upon the National Academies of Sciences, Engineering, and Medicine to conduct a study to examine the use of innovation inducement prize funds and push financing mechanisms as ways to stimulate investments in biomedical research and development that de-links costs from product prices.” (http://delinkage.org/democrat-drug-pricing-bill-2017-antibiotics-delinkage/)
In May 2017, the World Health Assembly (WHA) approved a resolution on cancer that gives the World Health Organization (WHO) a sufficient mandate to undertake a feasibility study of delinkage as it relates to the development of new drugs for cancer. (https://cancerunion.org/2017/05/31/wha-passes-cancer-resolution)
In 2014, WIPO published a study on alternatives to the patent system to support R&D efforts, in CDIP/14/INF/12. We suggest this study be presented at SCP27 under the agenda item on Patents and Health.
KEI is working with several other groups and governments to host technical meetings on the terms of reference for feasibility studies on delinkage, particularly as this relates to new drugs for antibiotics, cancer, HIV and rare diseases. We welcome engagement in this work.
Create pool for shared rights in publicly funded R&D
KEI proposes that WIPO create an instrument that would create reciprocal rights in government funded inventions, so that the countries that were members of such an agreement would agreed to the terms and modalities under which they could share access to government funded inventions.
The Canadian proposal
We take note of the Canadian proposal to conduct a review of existing research on patents and access to medical products and health technologies. The study should provide information about all of the cases where non-voluntary use has been allowed as a limitation on remedies, including, for example, recent limitations on remedies for infringement of patents on medical diagnostic tests and medical devices in the United States, the use of competition law in Italy, compulsory licensing of medical patents in Germany, and the use and impact of compulsory licensing of patents on drugs for HIV, cancer and heart disease in developing countries.
The Canadian proposal and Transparency
We also suggest the Canadian proposal be expanded to address issues relating to transparency as it relates to patent landscapes on biomedical inventions, including biologic drugs and vaccines, the litigation over patent validity and scope, the growing state practice of limiting the grant of injunctions when infringement occurs, and the economic aspects of drug development and commercialization, including the costs of R&D and the prices and revenues of products, as well as the utilization and gaps in access for new drugs.
Flexibilities in Part 3 of the TRIPS
We urge the SCP to schedule a presentation by experts on the legal basis and experience of states in permitting the non-voluntary use of patents on medical inventions as a limitation on the remedies available in Part 3 of the TRIPS, including specifically cases of running royalties for infringement of medical devices and diagnostic tests, and the export of those products outside of the WTO 31bis framework.