Representatives of the international pharmaceutical industry confirmed their commitment to contribute to the implementation of the targets set by the government
On May 14, 2019, Saint Petersburg within the 25th Russian Pharmaceutical Forum, the Association of International Pharmaceutical Manufacturers (AIPM), which is celebrating its 25th anniversary this year, held a press briefing on the current issues of pharmaceutical industry development entitled "On The Way from 25 to 80+: Impact of the Pharmaceutical Industry In Achieving National Healthcare Goals”.
The discussion chaired by Vladimir Shipkov, AIPM Executive Director, was joined by Vadim Vlasov, President of the Novartis Group Russia, Chairman of the AIPM Board of Directors, Vasiliy Ignatiev, CEO of the R-Pharm Group, Vice Chairman of the AIPM Board of Directors, and also by the following members of the AIPM Board of Directors: Eric Patrouillard, General Manager, Eurasia and Baltics, Pfizer, Ekaterina Pogodina, Director General of Johnson & Johnson, Russia and CIS, Managing Director of Janssen (Pharma Division of Johnson & Johnson), Oxana Monge, General Manager of Sanofi Eurasia, Matthias Wernicke, General Manager of Merck Biopharma Russia and CIS, Oleg Dubianskij, General Manager of GSK Pharma Russia.
Representatives of the Association, which brings together more than 60 leading international pharmaceutical companies, brought attention to their weighty contribution to the Russian pharmaceutical industry development over the last 25 years. Thus, according to the Ernst & Young study1, over the period of 2006–2016 alone, international pharmaceutical companies contributed RUB 1.14 trillion to the Russian economy, constructing over 20 new plants, actively participating in the modernization of existing production capacities as part of 59 partnership agreements and 18 mergers and acquisitions, creating over 15,000 new job opportunities. In addition, the participants of the press briefing confirmed that the international industry would be open for next circle of investments if there will be a sound investment climate secured and new incentives initiated, as well as a transparent and clear set of rules for the market players put on track.
The experts agreed unanimous that the public healthcare priorities put forward in the Presidential May decrees set out a very promising agenda for the further development of the industry. These priorities are rather ambitious and require innovative solutions appropriate to the task. The AIPM member companies once again stated their commitment to work alongside the state in achieving these targets and to provide access to innovative medicines and new therapy methods.
When opening the press briefing, Vladimir Shipkov, AIPM Executive Director, highlighted the role of pharmaceutical manufacturers as one of the major driving forces behind innovation in public healthcare and in pharmaceutical industry: "This year marks the 25th anniversary of the Association of International Pharmaceutical Manufacturers. Above all, our creation and development were guided by the interests of patients and society in the provision of affordable high-quality medicines. Thanks to the efforts of the AIPM members, the pharmaceutical landscape—at least in what concerns the localization of production—has changed dramatically, and the international industry's consolidated contribution to these processes is yet to be appreciated. Nevertheless, all these years, the companies have been supplying patients with life-saving innovations to treat the most challenging of diseases. Over the period of 2004–2017, Association’s members launched a total of 502 molecular entities onto the Russian market. These are medicines that were not previously present on the market . Out of these, 139 are patent protected innovative medicines. For this very reason, the companies are so concerned with the appropriate protection of intellectual property rights," he concluded.
Among other major factors intended to help Russia join the countries with a life expectancy of over 80 years and improve the accessibility of groundbreaking and effective medicines, the speakers also mentioned the following: developing advanced regulation, implementing efficient financing mechanisms for innovative treatment, expanding state guarantees in the public provision of medicines by introducing modern approaches to reimbursement for medicines.
"All in all, the contribution of the international pharmaceutical industry to the Russian economy can hardly be overestimated. In terms of investment volume, we are one of the leaders. We are building modern production facilities in Russia, providing transfer of technology, conducting clinical research, implementing educational projects, and fostering partnerships in research and development. Today, there is export potential for a whole range of innovative medicines localized in Russia. The targets set out in the "Pharma 2020" strategy could hardly be achieved without our participation. If we consider where the Russian pharmaceutical industry was 25 years ago and where it is now, it is obvious that it has made a giant leap forward. We are ready to continue bring and develop innovations, which can dramatically improve medical care and significantly increase living standards and life expectancy in Russia," said Vadim Vlasov, President of the Novartis Group Russia, in his speech.
Expanding and putting accent on the role of intellectual property, Vasiliy Ignatiev, CEO of the R-Pharm, noted that "the protection of intellectual property rights is one of the major tasks for the government. Without properly functioning legal mechanisms to ensure this protection, it is particularly hard to develop innovative technologies in the country. This is of high importance for the pharmaceutical industry with its rather lengthy cycle and high level of risk associated with investing in new products. Certain positive steps toward solving the problems relevant to this area have already been mapped out. But there is a need for a more systematic approach that encompasses many elements, such as the establishment of a unified register of patent protected intellectual property in the circulation of medicines; inclusion of information about current intellectual property rights in the Russian Federation into the registration dossier of drugs as well as a declaration of noninfringement upon third-party intellectual property rights; registration of generic and biosimilar medicines with a deferred date of validity; ban on price registration for generic products without consent of the proprietor."
Eric Patrouillard, General Manager of Pfizer Eurasia and Baltics, emphasized the following: "Although a lot of work has taken place, unfortunately we still see patented products losing their commercial exclusivity. This is of upmost importance as without the protection of intellectual property rights no innovation in pharmaceutics will be possible at all, and that also applies to local companies. Innovation is indeed indispensable to achieve the President objective to reach 80+ life expectancy. The most important mission of the thousands of employees of the AIPM member companies is to help a large number of patients suffering from a wide range of diseases all across the country. In other words, the life of Russian patients depends on all of us too, and here lies our great social responsibility. Protecting the local and foreign innovators from patent infringement is crucial to continue working for the benefit of Russian patients and their families."
Ekaterina Pogodina, Managing director of Janssen, pharmaceutical companies Johnson & Johnson, Russia and CIS, Director General Johnson & Johnson LLC noted that a patient-oriented approach to public healthcare should be regarded as important factor of future success. "It offers patients timely access to the best possible therapy. A lot has already been done in this area. For instance, the implementation of the price determination reform has started, federal programs for procuring antiretroviral therapy have been established, and a high-cost nosology program, which marked its 10th anniversary last year, is being successfully rolled out. However, a lot is yet to be done to improve the availability of innovative medicines. The provision of a set of tools, such as modern contract models, including risk and cost-sharing, or the mechanisms for a direct dialog between the state and the manufacturer, can lead to qualitative and positive changes for patients within a short time. Fine tuning the approach to selecting and prioritizing medicines to be included in the lists seems to be of equal importance. An independent assessment and the possibility to conduct modern comprehensive research, such as multicriteria analysis, in order to determine the priority of funding nosologies or certain medicines, are also essential to implementing a value-oriented approach in public healthcare, which in its turn will enable more effective use of budgetary funds."
The importance of introducing modern principles for healthcare technologies assessment (HTA) in the public healthcare was discussed by Oxana Monge, General Manager of Sanofi Eurasia. "We now have innovative biotech medicines to treat chronic diseases that can help patients make a full recovery over a period of two years. If we consider just the cost of treatment, it is indeed high. However, this is only in the short term period. The long-term outlook changes everything: consider, for instance, a patient's life over a horizon of 5–7 years, ones living standards, and the fact that no treatment of complications is needed in the future. If a patient achieves a full recovery, it means that the state will no longer spend budgetary funds on their treatment. And most crucially, the patient's life changes dramatically. This is just one of the examples, albeit an individual case; yet, it demonstrates a potential contribution of innovations to achieving our targets. It is important not only to consider the direct budgetary expenses on medicine procurement but also to make decisions based on scientifically proven information in the interests of patients as well as social and economic benefits for the state and population. Decisions concerning medicines to be included in the lists and the establishment of a system for the reimbursing the purchase of medicines should be made based on a modern approach as HTA."
Matthias Wernicke, General Manager of Merck Biopharma Russia and CIS, pointed out, "The Russian pharmaceutical market is on the verge of taking an important decision. A lot has been achieved within the "Pharma 2020" program. If we want to continue, if we want Russian science to be strong, if we want strong local production and a recognized position on the global stage, including in export-related issues, we need to keep solving issues relating to intellectual property and the speeding up of access to innovative medicines for Russian patients. Should no acceptable solutions be found for these areas, the industry will not only fail to harness its potential but will also be obliged to spend resources and time on overcoming unnecessary barriers at the expense of positive market dynamics. To maintain the dynamics, we need a joint dialog that aims to maintain growth."
Oleg Dubianskij, General Manager of GSK Pharma Russia, highlighted the major role that reimbursement for medicines play in increasing the average life expectancy. "The Russian drug provision system still has a lot of unsolved problems. This is particularly true of outpatient care. Due to the fact that the state drug provision programs have a low level of coverage (namely no more than 19%, while some experts believe it to be no more than 10%), patients suffering from a variety of diseases in most of the regions do not have guaranteed access to the medicines necessary. This concerns cardiovascular diseases, lung diseases, and many others that are the main causes of death, disability, and the decline in life expectancy and living standards. As a result, patients are either forced to pay for the medicines on their own or are unable to afford the required treatment. It is obvious that unless these problems are solved the ambitious targets cannot be attained. Many countries have managed to find a solution by implementing comprehensive programs of universal reimbursement for medicines based on a nosologic principle. These schemes provide patients with access to the medicines necessary (free of charge or by making a small co-pay) based on a prescription issued by a physician at the time of diagnosis. The key questions here are the following: What needs to be provided (which list of medicines should be used), who (which type of patients, which social categories), and how (i.e., with the help of which mechanisms, how the co-pay should be made, how much it should amount to, how the cost of administered medicines should be reimbursed to the pharmacy, at what price, etc.). We expect these details to be elaborated in the course of pilot projects." While answering a question on T&T for drugs, Oleg Dubianskij said that "the industry has reached a stage when it should make a good decision along with the regulatory authorities so that not a single Russian patient is in any way affected."
1 Research on investments made by international pharmaceutical companies in Russia in 2006 –2016, EY // Ernst & Young Valuation and Advisory Services LLC, February 2018.For additional information, please contact: