Generic manufacturers are against linking patent protection with drug registration procedure. Experts are sure, protecting the interests of one, barriers are created for other market participants. The legislative initiative will have a negative impact on both the Russian healthcare system and the pharmaceutical industry as a whole.
The Ministry of Economic Development has developed a roadmap for the implementation of the systemic change management mechanism for the legal regulation of entrepreneurial activity “Transformation of the business climate” in the area of “Intellectual Property”. The action plan involves amending the rules for the registration and examination of medicines for medical use, approved by the Decision of the Council of the Eurasian Economic Commission of November 3, 2016 №78, in order to improve the mechanism for preventing patent infringement through the creation of a single register of pharmacologically active substances protected by a patent for the invention and the establishment of the delayed start date of the registration certificate for the reproduce drug.
The proposed measures will make the issuance or validity of the registration certificate for the reproduced medicinal product dependent on the availability of patent rights to the reference medicinal product. Two areas of law are mixed, and this is unacceptable in countries with a developed legal system. Not one legal system does not allow such liberties for the glory of a patent.
“In today’s conditions, when doctors in an extreme situation fight for the life and health of each patient, primarily using generics, patentee lobbyists suggest restricting the entry of cheap drugs to the market, thereby reducing the availability of therapy and, accordingly, the possibility of saving these patients,” Victor Dmitriev ARPM director general, emphasized.
It is proposed to establish the beginning of the validity of the registration certificate of the reproduced medicinal product after the expiration date of the patent for the reference medicinal product, which requires the creation of a special register of patents formed by Rospatent upon applications from interested parties.
Generic pharmaceutical companies are also paying attention to the serious consequences of such measures. Due to the impossibility of carrying out all the previous procedures for the production of the reproduced medicinal product prior to the validity of the registration certificate for the medicinal product, the time period for launching generics on the market may increase by at least six months, therefore, the budget burden will increase, and patients will not be able to get affordable therapy. Innovative drugs are simply not affordable for the majority of the country’s population. Now in the EU and the USA, as well as in Russia, the reproduced drug can enter the market the next day after the patent expiration for the original drug.
Victor Dmitriev emphasized that the “patent linking regime” resembles mating a hedgehog with a snake and will have a dramatic negative impact on the availability of drugs, will have negative consequences for both patients and healthcare system budgets, and for manufacturers of generic drugs, will contribute to the artificial extension of the patent protecting and further monopolization of the markets. ”
Industry experts draw attention to the fact that the measures taken violate the principles of equality and justice, the foundations of the constitutional system of the Russian Federation, in terms of violating the principle of separation of powers, discriminatory conditions are created for bona fide manufacturers of generic drugs to access the Russian market, which forces Russian and foreign manufacturers change business plans and incur significant losses.
Manufacturers consider the introduction of “patent linking” in the Russian Federation not only inappropriate and not in line with national interests, but also dangerous for the healthcare system. The same applies to the regulatory legal acts of the Eurasian Economic Union.