Thank you for visiting this dialogue summary by Christopher Wong, New York Law School Fellow, students from his Intellectual Property & Activism class and an amazing group of practitioners in the field on Improving Access to Health. Intellectual property (IP) laws have a significant impact upon global welfare. In particular, healthcare. IP law is a big factor in the accessibility of essential medicines, treatments, and medical literature for those in need. For example, patents can make pharmaceuticals unaffordable for affected populations. Additionally, copyright law can access treatment to information for basic ailments.
IP law also plays a large role in the way scientists conduct research. IP protection on everything from indigenous knowledge and human genes can make it harder for future research. Including innovation and dissemination of better, cheaper treatments.
Practitioners are working to change the system to improve access to critical resources. Resources such as essential medicines and indigenous knowledge. Read the dialogue summary below to learn more about the approaches and tactics practitioners use in the intersecting areas of IP and health.
Intellectual Property Laws & Health
Intellectual property (IP) laws have had a significant impact on the global access to medicines. For example, IP law plays a large role in determining the way scientists conduct research. IP protection can also serve as an obstacle to health care access. For example, they prevent further innovation and they prevent treatments from reaching those in need. This online dialogue provided an opportunity to learn more IP and Heath. Especially the approaches and tactics used by practitioners to combat the health effects of IP laws.
Essential Medicine Access: A Global Concern
It generally takes 15 to 20 years to introduce a vaccine in developing countries after they are made in developed countries. In short, essential medicines are out of reach for poor people.
- The UAEM website points out that nearly a third of world’s population does not have regular access to essential medicines. Each year, ten million people die from diseases that have available cures. During the fifteen seconds it takes to read this paragraph, five people have died from preventable causes.
Price: A Barrier to Access
Cost represents a substantial obstacle for those in need of essential medicines. Many medicines are too expensive for the very people that suffer from the treatable illnesses. On the other hand, pharmaceutical companies enjoy large profits form the production of these medicines.
- The WHO Essential Medicines List (EML) defines essential medicines as those that are affordable. WHO selects essential medicines based on a list of criteria. These include; disease prevalence, efficacy and safety, cost-effectiveness, and offered at a price the individual and the community can afford. The many countries use the EML to set drug purchasing priorities for their national health systems.
- Researchers suggest that a more ethical definition of an essential medicine should be one that does not include the cost. Instead, medicines should be essential based only on medical need. Additionally, countries should take measures to make any medicine deemed ‘essential’ affordable.
IP as a Barrier to Access to Essential Medicines
There are many IP-related factors that represent a barrier to access to essential medicines. These include, patent, data exclusivity, and trade secret protection.
Patent
Pharmaceutical companies patent their drugs to prevent other companies from copying them.
- The first barrier presented by patent law is in determining what is “patentable subject matter.”
- Another barrier presented by patent law relates to the production of essential medicines. There are two basic types of medicines: small molecular drugs and biosimilars. Small molecular drugs can be chemically synthesized and produced in a generic and commercial form. Biosimilars, like vaccines, are more expensive to produce than traditional small molecule generics. This is because they cannot be synthesized. Additionally, generic companies will have to perform some amount of clinical trials before making biosimilars available to the public.
Data Exclusivity
- Data exclusivity is a protection given to data that is used by the drug authority (such as the FDA) to approve the drug for market.
- Unlike patents, data exclusivity is granted and cannot be challenged or invalidated. For example, with generic biologics, researchers have a sure shot at 12 years from data exclusivity whether you have valid patents or not.
- One solution that EU drug companies promoted is the EU-India Free Trade Agreement. This agreement sought to introduce data exclusivity in India. They would prevent generic drug companies from producing drugs, without running their own lengthy and expensive trials. Given that India is the pharmacy of the developing world, it is essential that they continue to make generic drugs.
Trade Secret Protection
- The fundamental right of a trade secret owner is the right to restrict access to, and use and disclosure of a trade secret.
- Purposeful confusion of legitimate generics with counterfeits are critical impediments to access.
- Trade secret policies protect process information about the manufacturing of biologics. There are two ways of addressing trade secret policies. 1) disclosure requirements. 2) technology transfer hubs or Patent Materials Know How pool. These compile all available information about a process.
IP Tactics to Improve Access to Healthcare
- TRIPS Agreement put forward by the World Trade Organization, which sets out minimal standards of IP laws to be upheld by member states.
- In 2001, WTO put forth the WTO Doha Declaration on TRIPS and Public Health. TRIPS is an Agreement on Trade-Related Aspects of Intellectual Property Rights. They did so in response to developing countries challenging the TRIPS agreement. These countries demanded more flexibility to allow for better access to essential medicines.
- The United States Trade Representative’s (USTR) Special 301 Report. The report rates the standards of intellectual property protection and enforcement in countries around the world.
- The Special 301 Report is criticized for being one sided. In response Consumers International publishes an IP Watchlist. This list provides analysis on which countries have the fairest IP laws and enforcement practices for consumers. Unlike the 301 report which focuses on the rights holders.
- Technology transfer to developing country manufacturers is an important strategy.
- The Medicines Patent Pool appears to be a step in the right direction that could be powerful if it expands. Its goal – is to negotiate “with patent holders to share their intellectual property with the Pool”. They then license it to other producers to help the production of affordable generic medicines. These medicines are “well-adapted for use in resource-poor settings.” Patent pooling is a possible means of cost reduction.
Obstacles to Influencing IP Policies
- Barriers to upholding the Doha Declaration’s provisions.
- The use of the TRIPS protocol has been too complicated for most developing countries to use.
- Providing the public with a clear narrative.
- Upholding laws that protect public interest. For example, the Bayh-Dole Act gives the US government with the right to allow others to use patents for medicines. If federal funds helped create these medicines.
- Politics as a Barrier to Access to Medicine:
- There are often conflicts of interest between Congress and Big Pharma. Free trade agreements are never free and are less and less about trade. ACTA (Anti-Counterfeiting Trade Agreement) is a perfect example. The US government denied the first request to see ACTA documents on national security grounds.
Activism: Breaking Down Barriers to Access Created by IP
- Activists can encourage boycotting products from a particular company. This approach is effective in conflicts with pharma companies because it threatens their income. Boycott pharmaceutical products – an example is the Novartis Boycott in India.
- Activists can work to apply political pressure to IP laws. For example, utilizing flexibilities within the TRIPS agreement. Additionally, critiquing the United States Trade Representative’s Special 301 Report
- Activists can also foster strategic partnerships. For example the Treatment Action Campaign from South Africa addressed issue of high cost of HIV/AIDS drugs. They collaborated with WHO and MSF to allow generic drugs to enter the country.
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