IP Clauses In FTAs Should Not Go Beyond TRIPS, Generics Manufacturers Say 04/10/2015 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)Free trade agreements should include incentives for generic and biosimilar medicines, speakers said at a panel during the World Trade Organization Public Forum last week. During a session titled “Principles to Foster Trade in Generic and Biosimilar Medicines,” organised by the International Generic Pharmaceutical Alliance (IGPA), speakers commented on the importance of generic and biosimilar medicines for access to health, in particular in developing countries. The WTO Public Forum took place from 30 September-2 October. On the panel, Murray Aitken, executive director of IMS Institute for Healthcare Informatics, a global information and technology services company, said most of the global burden of diseases can be addressed by existing medicines. Today, he said, generic medicines account for over 80 percent of the total medicines volume globally. Generic medicines play a vital role in controlling the costs and increasing access to affordable medicines, he said. The global generic market reached US$194 billion in 2014, he said, 43 percent of which are from branded generics and 57 percent unbranded generics. Global trade is vital for the generic sector, he said. Jim Keon, chair of the IGPA and president of the Canadian Generic Pharmaceutical Association, said many rules around trade and access to markets are imposed on industry. The generic industry has been active in many negotiations, but mainly reactive, he said. Four main areas of concern for the generic industry are: regulatory convergence, competition, incentives for introduction of new generics and biosimilars, and intellectual property, Keon said. Stringent IP Provisions in Trade Agreements; TRIPS to the Rescue Stringent IP provisions can prevent competition and delay the entry of generic and biosimilar medicines into the market, according to Keon. According to an IGPA document, “the increasing push for the inclusion of more extensive IP protection in FTAs” stands to alter the balance established by the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). IGPA members wish that the TRIPS standards, with its flexibilities, would be taken as the basis for negotiations on free trade agreements’ IP chapter, according to Keon. “The IGPA believes that the standards on patentable subject matter, novelty, inventive step, and industrial applicability, as well as disclosure, as reflected in the TRIPS Agreement, are instrumental to ensure the proper functioning of the patent system…,” the IGPA document said. Early disclosure and work on a patent is critical to ensure timely generic and biosimilar market entry, Keon said. Moreover, FTAs should not provide longer data exclusivity periods for biological medicines than for small molecule drugs, he said. FTAs should not seek to extend the terms of patent rights, he added. Patent and test data should not be made subject to border measures and criminal enforcement, he said. In particular, border measures should not apply to goods in transit. Regulatory Convergence Key According to Keon, regulatory convergence is desirable for generic companies. In particular, the single development for generic and for biosimilar medicines, and mutual recognition of good manufacturing practices inspections would be needed. Single development of generic and biosimilar medicines would lead in particular to the reduction of clinical development costs, the opportunity to re-invest potential savings, and the reduction of unethical repetitions of clinical trials, Keon said. Countries should provide incentives for generic and biosimilar medicines manufacturers to enter their markets, he argued, such as incentives stimulating competition and innovation, fostering savings for national health care systems and facilitating access to affordable medicines. Such incentives could be done through pricing and reimbursement policies. Incentives to generic and biosimilar medicines should balance the protection enjoyed by originators through patents and other IP rights, Keon said. David Gaugh, senior vice president, sciences and regulatory affairs, Generic Pharmaceutical Association (US), commented on the Trans-Pacific Partnership (TPP). It gathers 12 Pacific Rim countries, representing some 40 percent of the global gross domestic product and 800 million people, he said. Other countries might be interested in joining, he said, in particular South Korea, the Philippines, Thailand, Costa Rica, and Taiwan. This week, chief negotiators and ministers met in Atlanta (US) for what was hoped to be the “final round” of the TPP, he said. According to news sources, a key sticking point at the end was terms for biosimilars. The TPP provides for extensions of patent terms, delaying both the issuing of patents and the regulatory approval process, Gaugh said. The TPP fails to provide a system that affords incentives for challenging inappropriate, weak patents, or the ever-greening of patents, he said. He also said the TPP could put at risk the future and sustainability of global generic and biosimilar industries, if it there is a lack of balanced provisions, he added. Adrian Van Den Hoven, director general, European Generic and Biosimilar Medicines Association, remarked on the very high cost of developing biosimilars. Biosimilar products, also called follow-on biological products, or similar biotherapeutic products, are defined by the WHO as: “a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product,” (IPW, Public Health, 23 January 2015). In particular, the process to prove similarity with the originator biopharmaceuticals is extremely costly, he said. He said the members of his association had to buy biopharmaceutical products, which are extremely expensive at the scale of a clinical trial covering about 300 patients to compare results with the biosimilar. This comes at “huge expense,” he said. A lot of developed country patients have no access to biosimilars, he said, and the situation is much worse in developing countries. 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 Catherine Saez may be reached at firstname.lastname@example.org."IP Clauses In FTAs Should Not Go Beyond TRIPS, Generics Manufacturers Say" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.