These are the notes I used when providing the KEI comments at the July 25, 2017 civil society stakeholder forum at the 19th round of the RCEP negotiation.
My name is James Love. I work for Knowledge Ecology International, an NGO that focuses on the social aspects to the production, management and control of knowledge goods. I am also a member of the board of directors of the Union for Affordable Cancer Treatment.
The IP Chapter is complex, and in the time allocated, I will discuss five issues.
1. While the IP chapter touches on many areas of the economy, we are particularly concerned about the provisions in the agree that deal with drugs, vaccines and other medical technologies.
The RCEP members are already subject to the WTO TRIPS obligations on patents and other intellectual property rights, and the measures proposed in the RCEP by Japan, Korea and other countries would create new obligations to grant and enforce patents, extend patent terms, create monopolies on regulatory test data. Taken together, these measures are designed to expand and extend monopolies, leading to high prices on products.
The UN Secretary-General’s High-Level Panel on Access To Medicines called upon countries to avoid TRIPS+ provisions on medicines in trade agreements, and the RCEP proposals are in conflict with that recommendation.
High prices on products are in conflict with affordability, access and fairness. So the negotiators will have to decide if they want prices higher, or if they want to favor access and affordability. The Union for Affordable Cancer treatment calls on the RCEP to protect patient access, and also to look toward the future, which brings me to the second point.
2. All countries in the RCEP negotiation will confront an aging population.
Every RCEP country has its own demographic trends, and I only have time to mention a few.
- For Australia, in 1964, 8 percent of the population was 65 and over. By 2014 this nearly doubled to 15 percent, and the Australian government is projecting the 65 and over population to exceed 23 percent in the future.
- For Korea there will be a very dramatic change. In 2015, 13.1 percent of the population was 65 and over. BY 2030, it is projected to be 24.3 percent. By 2040, more than 32 percent.
- In India, the share of India’s population ages 60 and older is projected to climb from 8 percent in 2010 to 19 percent by 2050, according to the United Nations Population Division.
- In Indonesia, the number of persons 65 years and older is estimated to increase by between 7 to 14 percent from the current figure, according to a World Bank report.
- According to the United Nations, China is ageing more rapidly than almost any country in recent history. From 2002 to 2025, the percent of the population 65 and over will have increased from 7 to 14 percent, and China will officially become an “aged” society. China’s dependency ratio for retirees could rise as high as 44% by 2050.
The incidence of cancer increases with age, and societies need to look ahead, to design policies that are consistent with access to new medical technologies, at affordable prices.
3. Standards for Injunctions and Damages should not exceed TRIPS requirements
The RECP should not create new norms for injunctions and damages. Particularly troubling is the proposal to impose an obligation to give judicial authorities the ability to consider the suggested retail price of a product as a measure of damages. This is an inappropriate standard that is inconsistent with the laws of many countries, and it eliminates the ability to fashion liability rules that are consistent with Article 44.2 of the TRIPS agreement, not only for patented inventions, but for copyright also, including orphaned copyrighted works.
4. Test data should allow for exceptions
We oppose the granting of rights in pharmaceutical regulatory test data, but if such rights are introduced into the RCEP, member states should have the flexibility to have the same limitations and exceptions to those rights as are available in the case of patents, plus an additional exception, to address the conflict between test data rights and the ethical standards for medical experiments involving human subjects as set out in the 2013 Declaration of Helsinki on the Ethical Principles for Medical Research Involving Human Subjects.
Article 18 of the Declaration of Helsinki, on the Risks, Burdens and Benefits of research, says:
18. Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed.
When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study.
We also note that in the EU/Canada FTA, there is an exception to exclusive rights in agricultural regulatory test data, when duplicative trials violate the ethical norms for trials involving animals. The European Free Trade Association (EFTA)–Korea FTA (Article 3, Annex XIII) also provides for an exception to exclusive rights in test data for pharmaceuticals, when compensation is provided, which can be described as either compulsory licensing or a compensatory liability regime, depending upon the implementation.
These can be models for exceptions for trials involving human subjects.
5. The business model for medical innovation has to change, delinking R&D costs, including incentives, from the prices of drugs and other products.
The UN High-Level Panel on Access to Medicine, the World Health Organization, and a number of initiatives supported by national governments and health groups call for a change in the business model for funding R&D, including most importantly, delinking R&D costs, including incentives, from the prices of drugs and other products.
Going forward, it is important to progressively delink R&D financing from the prices of drugs, vaccines and other medical technologies. There is no possibility of “access to medicine for all” without delinkage. (More on this at http://delinkage.org)
The RCEP needs to enable a path toward delinkage. KEI recommends the following language be included in the RCEP, to ensure that RCEP member states can fully implement delinkage approaches, in order to improve the efficiency, cost effectiveness and fairness of the systems that support the financing of medical R&D.
“For pharmaceutical drugs, vaccines, medical diagnostic tests and devices, a member state may suspend requirements that exceed the WTO obligations on patents and regulatory test data for drugs, vaccines and other medical technologies, if alternative measures are undertaken that are at least equivalent in their impact on the funding of research and development.”