The development of innovative medicines in Russia is a strategic objective
“Innovations are our focus for the coming decade. <...> This has been set out in Strategy 2030 [Russia’s socioeconomic development strategy for the period to 2030 – ed.]. Top at our list of objectives is the development of our own innovative medicines,” Sergey Tsyb, First Deputy Minister of Industry and Trade of the Russian Federation.
We have seen in Europe, for example, that the development of innovative drugs contributed by a factor of 73% to increasing the longevity of patients over the last 15–20 years. So, 70% of the increase in longevity was due to innovative drugs. I think that is an important contribution that is something to be looked at here,” Koen Berden, Executive Director for International Affairs, European Federation of Pharmaceutical Industries and Associations.
“Innovations provide the opportunity to positively influence both the quality and length of life,” Ekaterina Pogodina, Director General, Johnson & Johnson Russia & CIS, Managing Director, Janssen, pharmaceutical division of Johnson & Johnson, Russia & CIS.
Innovations require a new regulatory framework
“Today, the process of testing technology must be clearly outlined in law in such a way that there is no doubt that when drawing up regulatory documentation and requiring compliance by pharmaceutical companies, we clearly understand that it works. <...> As a regulator, we must re-examine the view of the regulator from the position of both industry, and the personification of medical care,” Mikhail Murashko, Head, Federal Service on Surveillance in Healthcare (Roszdravnadzor).
“The innovation industry. The development of regulation in this area will depend on the development of the pharma industry. In terms of foreign investors, much will depend on whether they will bring innovative medicines to the Russian market, whether they will invest in clinical research, and whether they will invest in production facilities,” Vadim Kukava, Executive Director, Innovative Pharma Association of Pharmaceutical Companies.
“Protecting intellectual property is essential. Without it, it will be impossible to move towards an innovative sector and environment,” Ekaterina Pogodina, Director General, Johnson & Johnson Russia & CIS, Managing Director, Janssen, pharmaceutical division of Johnson & Johnson, Russia & CIS.
For pharmaceutical projects to be implemented, medical care needs to be accessible
“Accessibility is a key factor, and balanced solutions need to be applied at all levels to achieve this. <...> If there is genuine potential to cover as many patients as possible and to do it through our own resources, then that is what we have to do,” “Sergey Tsyb, First Deputy Minister of Industry and Trade of the Russian Federation.
“Quick access to drug therapy is an extremely important factor when it comes to implementing these projects,” Yuriy Zhulev, President, Russian Hemophilia Society.
Predictability is needed in the healthcare sector
“The healthcare industry must be stable and predictable,” Mikhail Murashko, Head, Federal Service on Surveillance in Healthcare (Roszdravnadzor).
“We have absolutely no desire to open Pandora’s box through suddenly taking decisions that other countries are not aware of. <...> It is important for us, and for Russia, to create an environment whereby agreements can be made with countries entering a single system. We need to reach agreements and set out what we may come to expect over the coming year,” Dmitriy Chagin, Chairman of the Board, Association of Pharmaceutical Manufacturers of the Eurasian Economic Union.
The population does not have equal access to medicines
“What is of greatest concern in Russian society? What is the most important issue? It is the need for fairness. The electorate are wondering why one person is able to receive a particular drug, while another is not,” Aleksandr Petrov, Deputy, Member of the Committee of the State Duma of the Federal Assembly of the Russian Federation on Health Protection.
“Our drug supply programme is not currently fair,” Yuriy Zhulev, President, Russian Hemophilia Society.
A flawed regulatory framework and red tape
“As the regulatory framework for pharma develops, it often runs counter to and even destroys those lofty and fitting goals stated in strategy documents,” Vadim Kukava, Executive Director, Innovative Pharma Association of Pharmaceutical Companies.
“We are wasting time in every area, in registering medicines, and in securing access to new technologies. <...> We are wasting time in procurement, we are wasting time in joining the list of subsidized drugs, and we are wasting time at the beginning of treatment,” Yuriy Zhulev, President, Russian Hemophilia Society.
Attracting investment for developing new medicines is difficult
“The problem is that we get to the pre-clinical stage, finish that, and then everything stops there. There is not a single investor who will enter clinical trials with us,” Andrey Kaprin, Director, Federal State Budgetary Institution National Medical Research Radiological Centre of the Ministry of Health of the Russian Federation.
New approaches to pricing
“There cannot be just one approach to prices, it must be variable,” Elena Maksimkina, Director, Department of Drug Supply and Regulation of Medical Devices at the Ministry of Health of the Russian Federation.
“Improving access to medicine costs money. That is where innovative approaches come in. There needs to be a partnership, whereby the government sits down with businesses and has a conversation about where they are willing to fund this expansion,” Oleg Dubyansky, Vice President, GlaxoSmithKline Russia.
Tax benefits and state guarantees for investors
“Laws need to become less stringent, and the tax burden must be reduced for those who are willing to enter clinical trials with us,” Andrey Kaprin, Director, Federal State Budgetary Institution National Medical Research Radiological Centre of the Ministry of Health of the Russian Federation.
As governor, my personal objective is to defend the interests of those who have demonstrated their belief in us, and to advocate their interests in every way, particularly when changes are under way,” Anatoly Artamonov, Governor of Kaluga Region.
A comprehensive approach to developing the industry
“It is important to know that when you are confronted with a disease, or you have something that you want to be addressed as a patient, the healthcare system is there for you. And that means all the actors in the system – that means the general practitioners, the doctors, the hospitals, the policy-makers, the regulators, and industry, as well as private and public insurance systems,” Koen Berden, Executive Director for International Affairs, European Federation of Pharmaceutical Industries and Associations.
“We have to address the ecosystem. We have to work on education, we have to work on legal and regulatory challenges. We have to think about whether we have the right infrastructure in place,” Lars Nielsen, Chief Executive Officer, Roche Russia.
Cooperation between producers of medicines
“Twelve years ago, there was not a single facility in our region producing medicines. Today, there are 62 members of our pharmaceutical cluster. We intend to develop this cluster further, because we are seeing synergy taking place. We are seeing producers of final dosage forms working together with companies producing active ingredients. There is cooperation,” Anatoly Artamonov, Governor of Kaluga Region.
A single system for clinical decisions
“Let us create a single system for taking clinical decisions whereby clinical recommendations are made together with our national medical centres. <...> We will prepare materials for patients to treat themselves responsibly, so they do not only rely on bits of information they gathered from browsing the internet, but act on verifiable sources of information,” Guzel Ulumbekova, Head, Higher School of Healthcare Organization and Management.
Training the required specialists
“A very important point is training doctors. Currently, pharmaceutical companies do a lot of the work, but it is important for us to pool our efforts, rather than have lobbying on behalf of particular medicines,” Guzel Ulumbekova, Head, Higher School of Healthcare Organization and Management.
“Any system where we do not look at the human capital and how to lead our role of educators, and train and educate the next generation of leaders that can help us solve the problem, will make this system fail,” Daniela Drago, Director, Regulatory Affairs Programs, Clinical Research and Leadership, School of Medicine and Health Sciences, George Washington University.
Monitoring new drugs
“If research on a drug is followed in a sufficiently thought-through way, then it will be possible to rework the budget in time to use it in the drug supply system. Identifying these drugs at an early stage and then using them in the system can lead to savings of up to 5%,” Dmitry Khalilov, Partner, Life Sciences & Health Leader, Central, Eastern and Southeastern Europe & Central Asia, EY.
Developing preventative medicine
“The entire paradigm is aimed at treating illnesses that have already manifested themselves. A federal project covering preventative medicine currently exists, which focuses mainly on infrastructure and human resources. However, we can all agree that it is better not to get ill in the first place than to rely on treatments. And the work we are currently putting into high-tech treatments for ill patients should not take our attention away from preventative medicine,” Mikhail Dubina, Academician, Russian Academy of Sciences.
Consider the views of professionals
“We must hear and listen to the professional community. I think we already have a positive dynamic in this regard,” Vladimir Shipkov, Executive Director, Association of International Pharmaceutical Manufacturers (AIPM).
For more information, visit the Roscongress Foundation’s Information and Analytical System at roscongress.org/en.