A Look At The Role Of Governments, Universities, Science In Health Innovation & Access 05/03/2018 by Catherine Saez, 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)Intellectual property rights, particularly patents, are considered by some as being a barrier in access to medicines despite being a stimulus for innovation. At a recent symposium co-organised by the World Health Organization, World Trade Organization and World Intellectual Property Organization, speakers also talked about the role of science, governments, and universities in health innovation and access, and how to address challenges such as secondary patents. Scene from the trilateral symposium The seventh trilateral symposium jointly held by the three organisations took place on 26 February at the WHO and was aimed at examining how innovative technologies can promote health-related United Nations Sustainable Development Goals. The programme included three panels: one on global health data, disease burden, and challenges ahead (IPW, WHO, 2 March 2018), one on technology as a driver of medical progress and access, and a final one on how policy choices impact on access to innovative technologies. Julio Raffo, head, Innovation Economics Section, Economics and Statistics Division, WIPO, took the example of antibiotics research and development to show the role of science, governments, and the pharmaceutical industry. He went through the history of antibiotic R&D, starting from the 1930s and the discovery of sulfanilamide, which gave birth to “sulfa drugs,” to penicillin in the 1940s, and on to streptomycin in the 1950s and 1960s. In the example of penicillin, he explained, its development in the 1940s started with its discovery by A. Flemming and its potential medical uses in 1929. But Flemming failed to purify it enough to test it. This was achieved in 1940, with Florey, Chain, and Heatley, but they failed to mass produce the antibiotic. The following year, the United States Department of Agriculture developed a medium for the mass production of penicillin, and convinced several large US firms to mass produce it. A decade later, in 1957, Sheehan developed the first pure chemical synthesis of penicillin, which later led to the production of synthetic penicillins, still in use today. Science is a pre-condition for innovation to happen, he said, adding it is impossible to bring an innovation to market without strong links between science and industry. Governments also played a key role, ensuring demand, and pushing mass production, he said. Governments, however cannot replace the scientific community, or industry, but can significantly affect the speed at which those two communities speak to each other. In the examples, private companies were responsible for scaling up production and delivering the products. Through time, pharmaceutical companies became large and internalised their research and development (R&D) process, also assuming the manufacturing and sales of the medicines. Patents, trademark and marketing became essential aspects of their business models. There was a co-evolution of the patent system and science and industry, as the antibiotic revolution helped create the modern patent-intensive pharmaceutical industry of today, he said in his presentation. Research is now focused explicitly on getting patentable inventions to be produced exclusively by large vertically integrated firms, he said. New technologies will reshape the health innovation system, according to Raffo. Pharmaceutical innovation related to chemistry is not among the most patented innovations these days, however devices now represent a large share of total health patents, while biotechnology patents are rising too, he said. Role of Universities in Access Luiza Pinheiro, student leader at Universities Allied for Essential Medicines (UAEM), Brazil insisted on the role of the governments, which are one of the main funders of universities and research centers. In Brazil, she said, universities are funded by the government and by Fiocruz, the Brazilian research federal institution. Universities should use their unique position to act as a protagonist in public health, she said, and provide open licences to their discoveries. She mentioned the Global Access Licensing Framework as one of the UAEM’s core activities. The framework provides global access policies for universities, which should have a clear and access-oriented licencing policy, she said. Technology transfer should preserve future innovation by ensuring that intellectual property does not act as a barrier to further research or to generic production, she added. Biotechnology, a Natural Partner, Price Fake Debate John Brennan, secretary general, EuropaBio and representative of the International Council of Biotechnology Associations, Belgium said some 350 million patients have been helped by biotechnology. According to Brennan, most biotech companies are mostly small and medium-sized enterprises. He said it takes a biotechnological product takes about 15 years from concept to market, and its development cost a lot of money, needs a lot of investment, and there are a lot of uncertainties, in particular the poor success rate of candidate products. Biotechnology can contribute to a number of the UN SDGs, he said, whether it is health, energy, or environment, he said, adding “we are a natural partner.” Innovation depends on incentives, he said, but there are a lot of challenges about incentives, he said, adding that the debate on price is a “fake debate.” “You really talk about funding, you don’t talk about price,” he said, as price is an aspect of funding, he added. Patents Get too much Attention Margaret Kyle, professor of Economics, Center for Industrial Economics CERNA, Mines Paris Tech. said there are three areas of policy options: patent protection, entry regulation, and price regulation. Patents are strongly associated with faster access to new drugs, she said, and also with significant price premium in rich countries, but not in poorer markets. Patents are also not associated with a reduction in quantities sold in developing markets, she said. Patents are not the only barrier to entry, but they get a lot of attention. A number of other barriers should be discussed as well, such as some regulatory requirements, she said, and focus should be directed to access to generic medicines first. Efficient and rapid provision of marketing authorisations is critical to receive access to new drugs, as well as to foster generic competition, she said, adding that this applies equally to rich and poor countries. She also said that if production is down to a single producer, that leads to very high prices. She remarked that some policy choices affect access in other countries. For example, she said, reference pricing may result in higher prices or reduced access in referenced countries, and parallel trade may lead to the exporting country experiencing shortages, higher prices, or reduced access. She also noted that excessive price regulation can deter entry and competition both for innovative drugs and generics. According to Kyle, differential prices by patent holders, could help solve access problems, adding that this is primarily the responsibility of richer countries. She also advised to coordinate health, science, and trade policies. Secondary Patents, Argentina Most Stringent Kenneth Shadlen, professor of Development Studies, London School of Economics and Political Science, UK talked about secondary pharmaceutical patents. He said the first patent is usually on the compounds, and secondary patents would be on alternative structural forms, such as formulations, compositions, dosages, combinations and uses. Usually, he added, the first patent is legally stronger. When a patent expires, secondary patents can extend periods of market exclusivity, he said “it happens all the time.” Secondary patents are either seen as “life cycle management” for proponents, and as “evergreening” by opponents, he said. To respond to the challenges brought by secondary patents, countries can use litigation or examination. He gave the example of India, Brazil, and Argentina. India introduced section 3(d) in its patent act, which explicitly ban secondary patents unless they have a proven enhanced efficacy. Brazil has a dual examination system in which patents are examined by the health authority, and then by the patent office, since 2012. Previous to 2012, patents were examined first by the patent office. This provides a de facto restriction on secondary patents, he said. Argentina adopted a highly restrictive patent office examination guidelines to prevent secondary patents. Measures introduced in those three countries had very little effects on secondary patent applications except in Argentina, according to Shadlen. The attention given to Indian section 3(d) might come from the fear of emulation, and indirect effects, he said. 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