Category Access to Medicine

Is the right to exclusivity a Hamlet question?

[Justice Prabha Sridevan] Today the judicial authority may be faced with balancing patent rights and patients’ rights or right to life. It shall use all the tools at its command and innovate if necessary, but shall rule in favour of life.

A New Trend in Trade Agreements: Ensuring Access to Cancer Drugs

[Maria Fabiana Jorge] Abstract: ... prices are clearly out of reach for most patients who will need them increasingly more to stay alive. While competition is critical to ensure lower drug prices, we have seen a number of strategies, including through trade agreements, to prevent competition and extend monopolies over these drugs and their very high drug prices. It is no accident that the exclusivity granted to biologic drugs has been one of the most conflictive provisions in recent trade agreements such as the United States-Mexico-Canada Agreement (USMCA) and the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP). Nevertheless a new trend in trade agreements started in 2007 when U.S. Members of Congress pushed back against the interests of powerful economic groups seeking longer monopolies for drugs.

Re-thinking Global and Local Manufacturing of Medical Products After COVID-19

[Germán Velásquez] The unprecedented global health crisis caused by the coronavirus (COVID-19) pandemic since the first quarter of 2020 has reopened the now-urgent discussion about the role of local pharmaceutical production in addressing the health needs in developing countries. The COVID-19 crisis has highlighted the interdependencies in the global production of pharmaceuticals—no country is self-sufficient.

Sen. Tillis Asks USTR to “Prioritize Strong Intellectual Property Protections” in Agreement with India

Thom Tillis, Chairman of the Senate Judiciary Subcommittee on Intellectual Property, has written U.S Trade Representative (USTR) Robert Lighthizer asking him to "prioritize strong intellectual property protections" in a trade agreement currently under negotiation with India. His letter states that "India has an unusually restrictive market when it comes to biopharmaceutical innovations," and notes that it is regularly included in the Special 301 Report.

Analysis of Special 301 Listings, 2009-2020

Since its inception, the Special 301 Report has been an instrument used by the U.S. Trade Representative (USTR) to pressure foreign nations to change their laws at the behest of American business interests. Policies that allow countries to access lower-priced generic medicines feature prominently in USTR’s allegations of inadequate, ineffective protection of intellectual property. This working paper reviews trends in Special 301 listings over the past 12 years.

United States: An Obsolete Trade Practice Undermines Access to the Most Expensive Drugs at More Affordable Prices

[Maria Fabiana Jorge] Access to affordable drugs is a top policy priority for the United States with real bipartisan support but it increasingly seems to be an unreachable goal, in part, due to conflicting government policies. While the Administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs highlighted the importance of competition to ensure lower drug prices, U.S. trade policy in general, and the Special 301 Annual Review in particular, do exactly the opposite: broaden and lengthen the monopolies granted to pharmaceutical companies thus delaying or deterring the launch of generic and biosimilar drugs and with that, the chances of lowering drug prices.

Creative Commons Is Now Leading the Open COVID Pledge—Here’s What That Means

[Diane Peters and Eric Steuer] We’re pleased to announce today that Creative Commons is taking on leadership and stewardship of the Open COVID Pledge. Earlier this year, CC joined forces with an international group of researchers, scientists, academics, and lawyers seeking to accelerate the development of diagnostics, vaccines, therapeutics, medical equipment, and software solutions that might be used to assist in the fight against COVID-19. The result was the Open COVID Pledge, a project that offers a simple way for universities, companies, and others to make their patents and copyrights available to the public to be utilized in the current public health crisis. Users of Creative Commons licenses will be familiar with the Open COVID Pledge’s approach. Like CC licenses, the Open COVID Pledge offers free, standard, public licenses that anyone can use to remove unnecessary obstacles to the dissemination of knowledge.

The TRIPS Agreement Article 73 Security Exceptions and the COVID-19 Pandemic

[Frederick Abbott] Abstract: The COVID-19 pandemic has caused Governments to contemplate measures to override patents and other intellectual property rights (IPRs) in order to facilitate production and distribution of vaccines, treatments, diagnostics and medical devices. This paper discusses whether the COVID-19 pandemic may be considered an “emergency in international relations” and how WTO Member States may invoke Article 73 (“Security Exceptions”) of the TRIPS Agreement as the legal basis for overriding IPRs otherwise required to be made available or enforced. It concludes that the pandemic constitutes an emergency in international relations within the meaning of Article 73(b)(iii) and that this provision allows Governments to take actions necessary to protect their essential security interests.

From Struggle to Surge: China’s TRIPS Experience and Its Lessons for Access to Medicines

[Peter Yu] Abstract: The WTO TRIPS Agreement has imposed unprecedented burdens on countries in the developing world. Although many developing and least developed countries continue to struggle with the Agreement's high intellectual property protection and enforcement standards, large or populous emerging economies, such as Brazil, China, India, South Africa, Thailand, have managed to adapt the Agreement with some success. As economic and technological conditions improved, these emerging economies began to secure even greater benefits from the TRIPS-based intellectual property system, thereby initiating a self-reinforcing virtuous cycle. Out of all emerging economies, no country provides a better illustration for a complete transformation of its intellectual property system and pharmaceutical landscape than China.

Expanding Access to Patents for COVID-19

[Jorge L. Contreras] Abstract: Two competing and linked sets of goals must be addressed when considering patent policy in response to a public health emergency. First is the allocation of existing resources among potential users (hospitals, patients, etc.); second is the creation of new technologies over time (innovation).

Webinar: Presentation of the MedsPaL Database by AMINA MAILLARD, Medicines Patent Pool

[Webinar - Sep 15, 2020; 10:00am] MedsPaL is the Medicines Patent Pool (MPP)’s patents and licenses database, a free resource provides information on the intellectual property status of selected patent essential medicines in low- and middle-income countries (LMICs). The database includes patent and licensing data covering over 8,500 national patent applications on 110 priority medicines (220 formulations) in more than 130 LMICs. In March 2020, it was expanded to provide patent information on treatments currently being tested for COVID-19. The database is available at www.medspal.org.

COVID and Copyright – The Right to Research

[Teresa Hackett] In Part II of this two-part blog, EIFL Copyright and Libraries Programme Manager Teresa Hackett examines how the COVID-19 pandemic has highlighted the importance of the right to research through two key issues, text and data mining and digital preservation by cultural heritage institutions, and how WIPO’s proven formula could address the issues. In Part 1 of the blog, we looked at the immediate challenges the COVID-19 pandemic posed for the copyright and licensing framework as education moved online.