May 13, 2021, Saint Petersburg — COVID-19 has had a significant impact on the socio-economic development of countries and especially with regards to the healthcare. For more than a year now, the world has been living in completely new conditions, and the pharmaceutical industry has made an important contribution in the efforts to find out optimal solutions to handling the fallout from the health crisis. During the press briefing of the Association of International Pharmaceutical Manufactures (AIPM), traditionally held during the Russian Pharmaceutical Forum in St. Petersburg, heads of the leading international companies and representatives of the patient community shared their vision of the key challenges and lessons learned following the start of pandemic. They also discussed emerging trends in development of regulatory environment, as well as what further steps are needed to successfully achieve the national healthcare goals. Almost each speaker brought attention to the point that current interaction mode demonstrates how successful the healthcare solutions might be if developed through close cooperation between regulators and the industry on regular bases, how significantly grew speed in decision-making across all sectors of the healthcare, while also stressing the need to focus on the patient-centricity when developing all state programs or initiatives.
The press briefing gathered the following speakers’ line-up:
With the participation of Yan Vlasov, Co-Chairman of All-Russian Patient Union, Head of the Council of Public Organizations for the Protection of Patients' Rights in the Federal Services for Surveillance in Healthcare.
Opening the event, Vladimir Shipkov, Executive Director of AIPM, stressed the importance and productivity of a continuous and professional dialogue with regulators at all levels and other stakeholders during the pandemic. “As part of this interaction, early last year, the pharmaceutical industry proposed the unprecedented package of measures aimed at transforming the regulatory environment in the interest of development the patient-oriented healthcare system and responding to the challenges posed by the COVID-19 pandemic in a flexible and timely manner. Practically all proposals were considered and incorporated into subsequent resolutions of the government of the Russian Federation. The results of the work are highly appreciated by all market participants. Now it is important that these changes become the real day-to-day routine practices so that they be irrevocable and consistent in the long-term period."
At the same time, as all participants stressed, the pandemic completely upended everyone's frame of reference and expedited the development of modern technologies in healthcare. These included the wide adoption of digital formats for interaction, which made it possible, among other things, to reduce the time it takes to review drug registration dossiers and issue permits for clinical trials, while also introducing a remote format for GPM inspections and using Real-World Data in the post-registration period. Modernization of the IT infrastructure, the further development of patient registries on digital platforms, and large-scale digital data analysis: the overall goal of all these developments is to help improve the patient-oriented approach to healthcare and would further boost the quality of medical service. At the same time, it is crucial to increase investments in the healthcare, while simultaneously implementing innovative public procurement models based on the evaluation of treatment outcomes, which will allow setting a fair price for innovative therapies and increasing patient coverage within the existing budget of the healthcare system.
“The pandemic served as a powerful incentive for accelerated decision-making in all areas. Things that we had only expected to see in the far and distant future are already happening now. Both the industry and the regulators managed to quickly adapt to the new realities. I am sure that these experiences can be a great starting point for the further industry development. At the same time, we believe it is necessary to upgrade many of the approaches used in the industry today, including healthcare technologies assessment. Specifically, we need to move away from the rule of zero impact on the budget when medications are included in the High-Cost Nozologies Program (VZN). Today both Russian and international manufacturers face the same choice: they can either significantly reduce the price of innovative medications to below the minimal reference level, or they can just not bring medication to market at all. It must also be kept in mind that behind every innovative medication there are 10–12 years of research and significant investment, averaging USD 2 billion, along with serious efforts to bring the medication to market. This means that the company must get a return on their investments as a financial basis for future R&D. Innovations must undergo a more comprehensive assessment, which among other things, should include the contribution they can make to extending life expectancy, quality of life, as well as economic benefits for the state. This can create a fundamental situation that, in the short and long term, can offer every citizen of the Russian Federation access to modern, innovative, safe, and high-quality medications regardless of their country of origin, which will improve the quality of life and allow people to live longer,” noted Oxana Monge, General Manager of Sanofi Eurasia and Chair of the AIPM Board of Directors.
“The pharmaceutical industry, including the companies that are members of the Association, really has taken a great responsibility and a great burden in terms of overcoming the pandemic. And we did manage to tackle the key risks. But that would not have been possible without optimizing the interaction between business, researchers, and the state, which allowed us to, in practically no time, achieve a breakthrough to improve the system for taking new technologies from purely fundamental research to market and, ultimately, to saving lives,” said Vasily Ignatiev, the CEO of R-Pharm Group and Vice-Chair of the AIPM Board of Directors. “The pandemic has really allowed us to refine in practice a number of changes to regulatory procedures. We can see that much of what has been achieved can be used outside the context of treating COVID-19, while keeping the focus on tracking the effectiveness, safety, and quality of medications in the post-registration period. Such mechanisms include, but are not limited to, accelerated registration, registration on conditions, registration for use in emergencies and pandemics, digital submission of market authorization dossiers, development of mechanisms for the collection and processing of efficacy and safety data through digital platforms and mobile applications, and much more...”
In addition, participants of the briefing noted that in order to ensure the pharmaceutical industry's sustained development, a favorable economic climate is essential. “Breakthroughs in healthcare are only possible if companies that bring new technologies to market are confident that their intellectual property rights will be protected and that they can get return on their investments in cutting edge research and development,” noted Natalia Kolerova, President of Novartis Group in Russia and Member of the AIPM Board of Directors. “Market sustainability, which is secured by the protection of intellectual property rights, contributes to the development of the healthcare as a whole system. In addition to significant investments in research and development, measures must be put in place to ensure that patients have free access to innovative treatments; it is also necessary to expand medication supply chains, develop infrastructure, launch diagnostic and educational programs, and promote partnerships with scientific and patient communities. To achieve effective interaction between partners in all these areas, we require clearly defined boundaries shaping ownership of specific intellectual property rights by which everybody can strictly abide.”
Separately, it is necessary to mention the sharp increase in recent years in the number of intellectual property rights infringements against R&D-based companies, namely the early release of generic drug copies before the expiration of the patents. “In this context, the pharmaceutical industry is in favor of creating a PharmaRegistries by the Rospatent and the Eurasian Patent Organization and hopes that the effective information exchange can be established as soon as possible between these two organizations and the Eurasian Economic Commission, in addition to the patent agencies and medication registration authorities of the member states of the Eurasian Economic Union,” Natalia Kolerova stressed.
Katerina Pogodina, General Director of Johnson & Johnson LLC, Managing Director of Janssen, a pharmaceutical division of Johnson & Johnson, Russia & CIS, and Member of the AIPM Board of Directors, spoke on the development of the single market of medicines within the framework of the Eurasian Economic Union (EAEU). Since January 01, 2021, Russia has completely switched to the registration of medicines in accordance with the law of the EAEU. From July 1, 2021, this should also happen in other member states of the Eurasian Union: Belarus, Kazakhstan, Kyrgyzstan, and Armenia.
“The EAEU single market opens up new opportunities for patients and healthcare systems. The Rules of the Union make it possible to introduce breakthrough innovations, such as CAR-T technologies, so we must harmonize the regulatory requirements of the EAEU and member states as soon as possible. Further bringing the rules of the Eurasian Economic Union into alignment with international regulatory practices also holds great promise, as it will facilitate access to innovations. Meanwhile, it is necessary to ensure harmonization of the procedures and processes with regards to protecting intellectual property rights and introduce a common 6-year protection period for exclusive data of pre-clinical and clinical trials in all EAEU Member States. Equally important is bringing medication dossiers into alignment with the new rules. This is an undertaking that demands colossal resources at the moment, but the procedure can be optimized. We hope to have a constructive dialogue with regulators on this and other issues, so that the transition to a single medications market will preserve and even expand patient access to treatments,” Katerina Pogodina said.
At the same time, the international pharmaceutical industry is concerned about several initiatives aimed at expanding protectionism and import substitution policy. That was one of the topics that Matthias Wernicke, Managing Director of Merck, Russia & CIS and Member of AIPM Board of Directors, touched upon: “Health and safety of patient is always a priority for us. Drug must be effective and safe, and its origin does not matter. The introduction of the so-called ‘2nd is out’ rule, a mechanism that deliberately eliminates alternatives that offer similar properties to medications already on the market, will leave both patients and doctors with on choice, creating ultimately conditions where some manufacturers obtain an unfair advantage. For the very same reason, we believe that the requirement to increase the percentage of Russian made pharmaceutical substances in the market will be counterproductive. The measure aims primarily to protect certain local manufacturers rather than the interests of Russian patients.”
The alternative to this approach would be to develop incentive-based state support measures instead of creating artificial barriers between the patient and medications. “A universal drug coverage can drastically improve access to medicine-based treatment for patients and shift the focus of state support from treating late-stage of the diseases and conditions to prevention, thereby reducing disabilities and extending average life expectancy. As a result, we will have a positive impact on health, demographic and economic indicators. We must also bear in mind the fact that the pharmaceutical industry is constantly progressing and innovating while creating new safe and effective medicines. The drug procurement system should also be progressive and take into account the patients' interests and their individual character. We believe that open dialogue and broad cooperation between regulators, industry representatives, and patients can bring about positive outcomes for everybody,” Matthias Wernicke noted.
Yan Vlasov, Co-Chairman of the All-Russian Patient Union, Head of the Council of Public Organizations for the Protection of Patients' Rights in the Federal Service for Surveillance in Healthcare, expressed solidarity with industry proposals for developing patient-centered approaches within healthcare system. However, he also noted that patients are concerned with budget constraints as well, seeing that year to year gap in covering needs of patients to secure purchases of medications in frames of the High-cost Nozologies Program (VZN) is growing. “The issues pointed out by the industry are very much relevant for the patient community as well. We have not even sorted out all the problems we run into when procuring medication under the ‘the 3rd is out’ rule, and we're already talking about a ‘2nd one is out.’ These procedures crucially reduce the accessibility of medication-based treatments as well as access to innovative technologies in general. Patients must be able to obtain medications not only under the international non-proprietary names but using brand names as well because we can see that there is oftentimes a significant difference between generics and proprietary medications for specific patients, unfortunately.”
As for the procurement of medications under the VZN program, today there seems to be a lack of understanding about how much money is needed to procure sufficient medication for all patients. According to the All-Russian Patient Union, some 3,500 people lack access to the treatment they need within the VZN program. This means that funds are insufficiently allocated. “We've asked the regulators to estimate how much it costs to treat each patient, and today we're seeing support from the Ministry of Health, which has begun support initiatives of public organizations aimed at estimating costs and determining whether funds are sufficiently allocated to finance new technologies. In order to ensure that innovative solutions are accessible to everyone who needs them, we must change regulatory documents in a manner that takes into account the interests of all concerned parties,” Yan Vlasov added.
Participants of the press conference noted that further development of effective healthcare system is impossible without focusing on the needs of patients. The international pharmaceutical industry once again expressed its willingness to engage in meaningful dialogue with state authorities on providing best available medical services and supply medications in Russia, taking into account the positive changes that have occurred in the field of regulation over the past year.
The Association of International Pharmaceutical Manufacturers (AIPM) was established in 1994 and represents in the Russian Federation the leading international pharmaceutical companies - producers and developers of modern effective, safe and high-quality medicines. Today, AIPM unites more than 60 international companies that provide over 80% of the world’s pharmaceutical products and over 60% of medicines imported to the Russian Federation.
For additional information, please contact:
Elena Yankovskaya, Communications Lead, AIPM
+7 (495) 933 70 40, E.Yankovskaya@aipm.org