Responding to the Challenges of the COVID-19 Pandemic

• The changes in the regulation environment and transition to digital interactions, which were aimed at fighting against COVID-19, have proven to be effective. This experience should be broadly exploited in the future to deal with other challenges that the national healthcare system is facing.
• Consolidating scientific expertise, technical and manufacturing capabilities, the industry continues to work in close partnership to find therapeutic solutions and vaccines against the pandemic.
• The quality and safety of medicines and a patient-oriented approach should be the top priority of any regulatory amendments.
• During the pandemic, we should pay special attention to the provision of medicines and support for patients with chronic diseases.

June 03, 2020, Moscow — Today, amid the COVID-19 pandemic, international pharmaceutical industry have consolidated efforts as never before to develop vaccines and medicines to fight the new coronavirus infection. Clinical trials on SARS-CoV-2 indication have been already launched by international pharmaceutical companies in Russia. The industry has been working with regulators—both at the global level and in Russia—to accelerate medicine and vaccine research, help the regulatory environment adapt to the pandemic restrictions, ensure the uninterrupted supply of medicines, and support the needs of patients, including those with chronic diseases. Companies are aware of the challenges that patients are facing now and believe that all developed anticrisis solutions should be, first of all, based on patient-oriented approach. This was reported by leaders of the world's major pharmaceutical companies operating in Russia at the annual AIPM media briefing, which this year was held online on May 28.

The discussion gathered the following speakers’ line-up:

• Oxana Monge, General Manager Sanofi Eurasia, Chair of the AIPM Board of Directors;
• Vasily Ignatiev, CEO of R-Pharm Group, Vice Chairman of the AIPM Board of Directors;
• Eric Patrouillard, General Director of Pfizer, Eurasia and Baltics, Member of the AIPM Board of Directors;
• Oleg Dubianskij, Vice President and General Director of GlaxoSmithKline Russia, Member of the AIPM Board of Directors;
• Natalia Kolerova, President of Novartis Group in Russia, Member of the AIPM Board of Directors;
• Katerina Pogodina, General Director of Johnson & Johnson LLC, Managing Director of Janssen, a pharmaceutical division of Johnson & Johnson, Russia & CIS, Member of the AIPM Board of Directors

With the participation of Yuri Zhulev, co-Chairman of the All-Russian Union of Patients, President of the All-Russian society of hemophilia.

Vladimir Shipkov, Executive Director of AIPM, opened the media briefing with a video message from the Association's member-companies expressing gratitude to doctors, healthcare workers, and volunteers, paying tribute to the heroic work of those who are at the forefront of the fight against the COVID-19, protecting people's lives and health.

"The pandemic has made us all reconsider healthcare issues, and how the industry can address them. In fact, we are as the industry have set a three-pronged task in front of us that we pursue at the global, regional, and local levels: 1) facilitate the development of the optimal regulatory solutions to efficiently fight the coronavirus; 2) research and develop new vaccines and drugs; and 3) ensure the uninterrupted supply across the entire range of medicines produced by member-companies of the Association, wherever these drugs are produced. We are glad that the government and relevant authority bodies are listening to us and are ready to find proper decisions quickly and flexibly in order none of the patients will be left without the medicines they need," stressed said Vladimir Shipkov, Executive Director of AIPM.

"The pharmaceutical industry currently is making unprecedented efforts to find solutions for the prevention and treatment of coronavirus infection both in the world and in Russia. Leadership and partnership are two words that characterize the approaches of the pharmaceutical industry today the best way, and are a key ingredients in finding the solutions. This crisis has shown that even the most complex issues can be resolved faster and more effectively when we all stand together to achieve a common goal. For example, the implementation of new digital approaches and formats of work has sharply accelerated, and the government has approved a whole range of vital regulatory initiatives in the shortest time possible. I think it is extremely important to preserve this spirit of cooperation, which we all feel now being fighting against a common problem, in the future. This is a good example how we can quickly resolve issues while maintaining focus on the interests of patients, as well as the practice of optimizing regulatory procedures, which contributes to accelerated access of patients to innovative treatment. We would very much anticipate keeping these approaches to work further and bring them to the post-crisis period. This unique experience can and should be considered when addressing tasks and challenges that our healthcare system will face in the future," said Oxana Monge, General Manager of Sanofi Eurasia, Chair of the AIPM Board of Directors.

Today, more than 20 international pharmaceutical companies are involved in the R&D for vaccines, medicines, and diagnostic tests for COVID-19[1]. According to the WHO, 10 candidate-vaccines are currently in clinical trials, and 123 more undergoing preclinical evaluation. At the same time, immense human and financial resources are being invested in finding new treatments for the disease. Research is ongoing to explore the application of more than 230 medicines against COVID-19, more than 142 of which are on clinical trials phase[2]. In addition to investments into the R&D activities, international companies have provided financial support and in-kind donations for urgent needs of national healthcare systems, which total about $700 million[3].

«In confronting this crisis, we believe that science will win. The innovative pharmaceutical industry is united in confronting the public health challenge posed by the COVID-19 pandemic. Harnessing our collective scientific expertise, technical skills and manufacturing capabilities, we will continue to work as one team across the industry and the global health community to fight – and end – this pandemic. In Pfizer we are working on 4 potential mRNA-based coronavirus vaccine candidates, and on a potential antiviral treatment. We are actively scaling up our manufacturing capacity and distribution infrastructure at risk to support global supply in response to the pandemic. In Russia, Pfizer has developed and is implementing a comprehensive plan, aim to address the urgent needs of medical organizations working to slow the spread of the virus within our communities. During these challenging times, our thoughts are with the Russian healthcare workers, patients and families affected» - Eric Patrouillard, General Director Pfizer, Eurasia and Baltics, Member of the AIPM Board of Directors.

In order to ensure the uninterrupted supply of medicines and sustainable provision of patients with drugs, to optimize medicine import procedures and keep clinical trials safely on track, the Association submitted a set of proposals to the Government of the Russian Federation in March this year, most of which have been accepted and are already in place. "All these changes make it possible to timely fix problems that appear in the supply chains and prevent a shortages of medicines despite the limiting restrictions related to the spread of COVID-19. However, a number of important questions remain open. Among them, in particular: the full-scale introduction of T&T system – AIPM calls for postponing it until the improvement of the epidemiological situation, i.e. at least until January 1, 2021, as this may seriously affect the availability of medicines; as well as the need to extend the validity of GMP certificates and conduct remote GMP inspections," - said Vladimir Shipkov. 

"The coronavirus outbreak has taught us all to work in a new environment, and this applies to both the industry and regulators. In April, a few fundamental documents were passed that have dramatically changed the regulatory landscape. Many of these innovations, which are temporary for now, may successfully be used in the future. In particular, I am referring to the accelerated issue of permits for clinical trials when the problem is of social significance; the transition to electronic workflow when submitting registration files and applications for clinical trials; the accelerated registration of drugs and medical devices; as well as development of other formats of GMP inspections via virtual and documentary analysis. We should probably try to create independent criteria to make possible the future implementation of these measures. The trend is very positive, and one of the key tasks as we are abandoning the epidemiological scenario is to preserve those practices—the rational kernels—that we have seeded today," said Vasily Ignatiev, CEO of R-Pharm Group, Vice Chairman of the AIPM Board of Directors. R-Pharm is currently conducting clinical trials of a number of candidate drugs for the treatment of COVID-19, including two drugs that block the inflammatory cascade (cytokine storm) in the patients with the medium-severe course of coronavirus infection.   

During the pandemic, many patients with chronic diseases have faced difficulties in receiving subsidized medicines as well as feel lack of information about how medical aid is provided in the current situation. "I would be lying if I said that patients are not encountering any problems with the provision of medicines in the context of COVID-19. This is not true, and it is a huge challenge for all healthcare systems around the world. Russia is not an exception. I would like to highlight two aspects. In particular, we have long been struggling for the draft law on on-line trade of medicine. But we are still not fully satisfied with the decision came out. I am sure this should also be applicable to prescription medicines. Today, patients with chronic diseases have found themselves in a difficult situation. On the one hand, they have to comply with the lockdown measures. On the other hand, they have to leave their homes a few times to for the first get the prescription and then find a pharmacy that sells the medicine. In some nosologies and regions, the process is more or less well-organized, thanks to volunteers as well. In other situations, the process is sheer hell for patients. That is why the logistics of remote prescription and delivery are crucial. The pandemic has highlighted these issues even more. At the same time, the All-Russian Union of Patients sent a letter to the government asking it to consider postponing implementation of the full-scale Trace & Track system until January 1, 2021. Pharmaceutical producers should not be self-centered. There are many companies that are ready to produce products in full compliance with the Trace & Track system reqirements, but the same cannot be said of other participants of the chain, many distributors, and pharmacies as well as hospitals. In the current epidemiological situation, we have to eliminate all barriers that may stand on way of medicines from the manufacturers to patients. Our hotline also shows that access to medical care for patients with chronic diseases has decreased dramatically due to COVID-19. This aid is routine, but sometimes urgent and life-saving. We turned to the Government, Ministry of Healthcare, and Federal Compulsory Medical Insurance Fund to address the issue, and we're very happy to see the two items in the President's May orders forbid lowering the level of healthcare provided to patients with chronic diseases," said Yuri Zhulev, Co-chairman of the All-Russian Union of Patients, President of the Russian Hemophilia Society.

Another vital aspect related to restrictions arose in healthcare due to COVID-19 — interruption in preventive vaccination — was discussed by Oleg Dubianskij, Vice President and General Director of GlaxoSmithKline Russia, Member of the AIPM Board of Directors. "With the new coronavirus infection that provokes uncertainty, some or other restrictive measures have been maintained already for a few months. The issues of elective healthcare, including preventive vaccination, have become increasingly more prominent. We know that many Russian regions are reducing the scope of preventive vaccination, and routine vaccination has become temporarily unavailable. It is crucial to ensure the stability of preventive vaccination programs, in particular, of child immunization, since disruptions in this field could lead to an increase in morbidity from vaccine-preventable diseases and further stress on the healthcare system, which is already experiencing severe difficulties due to the pandemic. We know that the Ministry of Health of Russia has developed a set of recommendations based on the WHO's opinion and sent it to the regions urging them to renew immunization, certainly, this should be done in full compliance with the measures to prevent the spread of the coronavirus infection."

Natalia Kolerova, President of Novartis Group in Russia, Member of AIPM Board of Directors, noted that companies have not stopped the technology transfer projects they launched before the crisis and have maintained the planned volume of local production. "As all industry participants, Novartis has taken all necessary measures to ensure uninterrupted supply so that patients do not experience shortages of medicines they need in terms of all our nosologies. Where necessary, we have also maintained the uninterrupted supply of medicines to our clinical trials partners and their participants. I would also like to note that the coronavirus epidemic has not impaired our work as part of the "Pharma-2020" and "Pharma-2030" strategies. We have not stopped our production, our site in Saint Petersburg has been working as normal, and we have continued technology transfers and the production of localized drugs. We have been doing everything in our power to provide maximum support to the healthcare system in different areas, including organizing clinical trials in Russia on a range of our innovative medicines that may help improve the condition of patients with severe coronavirus infection in clinical practice.  This is yet another example of professional areas of responsibility that the pharmaceutical industry has been steadily implementing. A partner in need is a partner indeed. We all are doing our best to remain a reliable partner of the Russian government in the current situation."

Katerina Pogodina, General Director of Johnson & Johnson LLC, Managing Director of Janssen, a pharmaceutical division of Johnson & Johnson, Russia & CIS, Member of the AIPM Board of Directors, is convinced that the pharmaceutical industry in Russia responded well to the challenge of COVID-19. "The situation has identified a range of problem areas, but the Russian regulator, industry, and patient community have managed to quickly establish a dialog to find a solution to acute problems as quickly as possible. The pandemic has shown once again that a stable healthcare system is crucial for the effective functioning of the economy and state as a whole. The need for the prompt development and fast market entry of innovative medicines has become a defining and essential component of ensuring this stability in the current situation. As a leader of the world's healthcare, our company is ready to take an active part in the development of optimum solutions and initiatives to ensure uninterrupted access for patients with chronic diseases to health care despite the external challenges. I hope we can preserve all the best practices developed in this difficult period."

"Perhaps, today is the first time when words such as 'dialog,' 'partnership,' 'patient priority,' and 'heroism of medics' are heard so often. We have come to a situation when a common disaster created conditions for all developing companies to unite, when they usually used to compete. Considering the lessons we have learned, the industry, regulators, and all stakeholders should keep this framework to develop a truly patient-oriented healthcare system in Russia," said Vladimir Shipkov summing up the results of the briefing.

About:

The Association of International Pharmaceutical Manufacturers (AIPM) was established in 1994 to represent leading international pharmaceutical companies operating within Russia. Its members produce and develop modern, effective, safe and high-quality medicines. AIPM unites 60 international companies, which account for over 80% of the world's pharmaceutical production and over 60% of the volume of medicines supplied to the Russian Federation.

For more information, please contact 

Elena Yankovskaya, Head of Communications, AIPM

Tel.: +7 (495) 933 70 40 (ext. 109), E.Yankovskaya@aipm.org

[1] According to data of IFPMA, https://www.ifpma.org/covid19/

[2] https://biorender.com/covid-vaccine-tracker/ 

[3] Data provide by IFPMA: https://www.ifpma.org/covid19/