Roundtable: ‘Appropriate Level’ Of Protection Is Key For Impact Of Patents In Health, Innovation 03/01/2017 by Peter Kenny for Intellectual Property Watch Leave a Comment Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)One of the key questions around the impact of patents on health and innovation is what is the appropriate level of protection for companies innovating, says Dr. Marie-Paul Kieny, assistant director-general, Health Systems and Innovation, at the World Health Organization. Kieny spoke at a roundtable discussion in Geneva on the impact of patents in the field of health and innovation. Roundtable at the Swiss Press Club in Geneva. L-R: Ducor, Rochel, Kieny, Girardet The panellists were Kieny, as a key global health administrator from WHO, along with a specialist in innovation and ethics from a Swiss think tank, and a law professor from Geneva University who is also a qualified medical doctor. The discussion was held the same day that Kieny told journalists at the United Nations in Geneva that an experimental vaccine against the Ebola virus was found to be 100 percent effective, according to a study published in the Lancet magazine. Kieny said the results offer hope of better protection against the disease that devastated West Africa in 2014, killing more than 11,000 people. Roundtable moderator Ed Girardet, a veteran Geneva journalist, introduced the participants, noting that the pharmaceutical industry argues that patents pivot around a financial incentive to encourage and sustain research. Against this doctors, patients and people in poor and developing countries can see patents acting as an impediment to lower prices for medicines by protecting their intellectual property. At the 22 December meeting in the Geneva Press Club, the speakers were: Kieny; Johan Rochel, vice president responsible for ethics and innovation for the Swiss think tank Foraus; and Geneva University law professor Philippe Ducor, a qualified advocate and medical doctor. Their submissions looked more at questions around the issue of patents in the pharma industry rather than arguing for particular solutions in an arena that all the speakers noted is particularly complicated. “Patents greatly concern people in their work at the WHO to increase the access of all to medicine,” noted Kieny. ‘Reward Innovation’ In principle, patents are given to reward innovation which advance society by being a utility. States give rights to innovators. Regarding the appropriate level of protection, however, Kieny said the system is “not linear.” Questions arise as to whether a system allows for the most protection [to society], stimulates the most innovation or the most research for development. Or, she said, too much protection for consumers can lead to inefficacy of medical systems when they lead to the pharmaceutical industry losing interest in manufacturing due to low prices. Then there are the multilateral treaties such as TRIPS (World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights), bilateral accords, and plurilaterals such as the Trans-Pacific Partnership (TPP), which are regulators of patents. “Each new extension for the validity of a patent in effect creates a delay for the entry of generic medicines into the market,” Kieny said. An extension for the patents can sometimes use the tactic known as “salami slicing.” This is where drug manufacturers break down populations into small, narrowly defined treatment groups and add additional designations for additional indications of a drug, in order to reap larger returns. This can be done on the justification of further research that is needed or medicament users can argue it is to protect the manufacturer and profits. Kieny noted that innovation costs a lot and involves great risks and that it is good to protect innovators. Marie-Paule Kieny addresses UN press in Geneva But on the other side there is the problem of ethics in the valuation of patents which are often based on the financial estimation of a drug’s worth to a company rather than the cost of the research in developing it, she explained. When she was elaborating on the new Ebola fighting development to journalists before the roundtable, Kieny said it was hoped to have more than one vaccine, “because as you know monopoly is never good.” “You never know if a manufacturer might drop out, so we need to have more than one vaccine,” she said. The reason why WHO was involved on the ground in Guinea in developing the vaccine was because there was no one else who wanted to do the trial, Kieny said. ‘Distributive Justice’ Ethicist and innovator Rochel said the debate around patents for medicine hinges on “a question of distributive justice” because it concerns “access to the fruits of innovation.” He said this links to the Swiss laws that are intertwined with international regulations, particularly the TRIPS Agreement through the WTO. The TRIPS Agreement, which came into effect on 1 January 1995, is considered the most comprehensive multilateral agreement on intellectual property, and sets the minimum standard, said Rochel. He said that Switzerland as the seat of a number of key players in the global pharmaceutical industry has an important role to play in the ethics of patents and their role in shaping standards. When it comes to questions of human rights there is the dilemma of whether such rights concern the inventor at a moment, or the rights of society to use the results of the invention, he said. Kieny said that in some countries, particularly Latin American nations, human rights regarding the right of everyone to all medicines are enshrined in some constitutions. Ducor began his submission by noting the incongruence of patents being a technical discipline determined by non-technical issues. He observed that a patent is an intellectual property right granted to the owner of an invention, prohibiting third parties from using it in a professional capacity, and therefore for commercial purposes. Patents produce a dilemma for intellectual property rights, in that they exclude information, while they diminish the freedom to inform society of such information at a time it might be in need of it, by privatizing it, he said. Looking at the essential medicines listed by WHO, Ducor said the huge majority of people are not protected by patents. “It is extremely difficult to see how a patent can protect society,” he said, while noting the difference between patents and exclusivity rights. Period of Exclusivity Kieny remarked that the exclusivity time period of a patent is the problem, and Ducor agreed. He said also that exclusivity is not intellectual property, it’s about administrative rights. The protection is limited in time, and it is the legal system that gives exclusivity, and Kieny said therefore it is not necessarily the patent that holds back the development of generics. Ducor argued that the system in the United States, the Food and Drug Administration provides some equilibrium but is not perfect, in the country that is “El Dorado for the pharmaceutical industry” (referring to the legendary city of gold sought by the Spanish in the Americas). In some cases, the law allows individual professors at universities to hold a patent rather than the institution. He also referred to the Bayh-Dole Act or Patent and Trademark Law Amendments Act, a US legislation dealing with intellectual property arising from federal government-funded research. Regarding the history of human rights, Ducor referred to the French Revolution through which the privileged rights of princes were given by the realm to ordinary individuals, allowing citizens the right to intellectual property. “There is much discussion on actual human rights but there are few theses published linking innovation, intellectual property, access to care and human rights,” he said. At the end of the roundtable, Kieny in answer to a question said, “WIPO [the World Intellectual Property Organization], the WTO and WHO support collaboration.” They have a trilateral project with a planned meeting on this to analyze the impact of the likes of patents and the TRIPS Agreement. Image Credits: Peter Kenny Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Related Peter Kenny may be reached at info@ip-watch.ch."Roundtable: ‘Appropriate Level’ Of Protection Is Key For Impact Of Patents In Health, Innovation" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.