Even if Pharma 2030 is 80% complete, it will be a great success

2020 was a pivotal year for the Russian pharmaceutical industry. This year saw the end of the government's ambitious Pharma 2020 program and the launch of the new Pharma 2030 strategy. Denis Remenyako, General Director of the pharmaceutical company FC Grand Capital, spoke about the results of the past decade and the prospects for the next, about the impact of the pandemic on the development of the Russian pharmaceutical industry, and about the future of the domestic pharmaceutical market.

— How do you rate the government's new Pharma 2030 strategy?

— The Pharma 2030 strategy is a significantly more mature document than the Pharma 2020 strategy once was. The two programs have completely different agendas. Whereas the first one emphasised increasing the share of domestic medicines on the Russian market, the new strategy focuses on the country's medicinal safety. The government has seen the problems encountered in the first program and has spelled out ways of solving them in the second.

All the areas that are spelled out in the Pharma 2030 program are very important. Thus, the government has realised the depth of the problems associated with the rapid production of pharmaceutical substances in the country. Pharma 2030 stipulates that attention should be paid not only to the local production of pharmaceuticals and pharmaceutical substances, but also to the production in Russia of chemical, biological ingredients, catalysts and other substances that are used in the production of pharmaceutical substances. It has become clear that without this, full-scale production of pharmaceutical substances is not possible.

The new program is also expected to bring the Russian inspectorate to a new level. I very much hope that it will soon be recognised abroad. This would make life a lot easier for exporters and speed up future exports for producers.

Much has already been done in this regard during the implementation of Pharma 2020: a system of manufacturer assessment in accordance with the Good Manufacturing Practice Rules has been put in place. However, the conclusion of compliance with these standards is mainly recognised in the former Soviet Union, and we would like to gain recognition not only from our immediate neighbours, but also from the rest of the world.

This also applies to the clinical trials that are being conducted by the developers. Today, a manufacturer who has registered a medicine in Russia, when trying to register it abroad, often has to conduct clinical trials abroad again, because the Russian results may not be recognised there (for example, in Europe or the USA). The Russian Ministry of Industry and Trade allocates funds to our developers for clinical trials abroad. But of course, it would be better if research conducted in Russia were globally recognised. This versatility will allow domestic pharmaceutical developers to significantly reduce the time it takes to enter foreign markets.

The Pharma 2030 program is also about developing the competencies of the pharmaceutical industry - training, creating and introducing new technologies, etc. I really hope that the ambitious objectives set out in the strategy will be backed up by adequate funding.

— In your opinion, how realistic is it to implement all this by 2030?

— A journey of a thousand miles begins with a single step. However, it is not only up to the government, but also to the market participants. If manufacturers know in which areas they can be supported, apply for the help that is outlined by the state and develop in accordance with the state program, this will lead to success both for individual pharmaceutical companies and for the industry as a whole. Even if Pharma 2030 is 80% complete, it will be a great success

— How are market participants responding to the changes taking place? Do they agree to develop the directions indicated by the state?

— When Pharma 2020 was launched, the market was sceptical. At that time, even our manufacturers had little faith that anything could be changed for the better in Russia in this industry, and large international companies were sceptical of the ambitious goals of a developing state. But the steps that have been taken in the last ten years have forced absolutely everyone to reconsider their positions.

In particular, there have been major changes to the requirements for localisation of production. We have stopped recognising as localised production the process whereby a medicine brought into Russia from abroad is put into a box created in our country. Only products that are actually made in the Russian Federation are recognised as domestic. And that was an important step.

Also, the "third wheel" rule was introduced, which effectively forced foreign manufacturers to make a decision: either you localise the production of your product in Russia, or you withdraw from the Russian market. These and many other measures have provided quite a boost to the development of our pharmaceutical industry. The market saw this and believed the state. Today, everyone is following very closely the programs the Russian government is implementing and they are entering the new decade with a different attitude. Not yet everyone has come to the conclusion that it is possible and necessary to develop the production of own forms and substances on the territory of the country, but I think they will soon believe it too, and we will see businesses interested in developing the full cycle of pharmaceutical production.

— Should we invest in pharmaceutical science?

— The Pharma 2030 strategy has drawn attention to this, as the development of science is an important element for the success of the entire industry. Creating new medicines, molecules and components for pharmaceuticals is extremely difficult, and investment in this area in Russia is extremely low when compared with Western countries. But I very much hope that the development of science will be one of the priority areas that will be separately funded, so that we can develop and create our own promising new products.

— In your opinion, what has not been taken into account in developing the Pharma 2030 strategy? What other problems in the industry are worth looking at?

— There are good and necessary initiatives that were spelled out in the Pharma 2020 strategy, they were not fully implemented but got lost and were not included in Pharma 2030. For example, there were plans to introduce a special fast-track registration procedure for Russian manufacturers. This has not been implemented. Unfortunately, today the Russian manufacturer lives in our country under the same rules as the foreign one: if it is supposed to wait a year for a medicine to be registered, then it has to sit and wait a year. There are no preferences for the Russian manufacturer from the Ministry of Health. But they should certainly be.

— In your opinion, how has the pandemic affected the development of the pharmaceutical industry in Russia?

- The pandemic has shown how important it has been over the past decade to develop pharmaceutical production in Russia. If the Pharma 2020 program had not been adopted at the time, and measures had not been taken under this program to develop the production of medicines in the country, the pandemic situation would be much worse today and there would be more deaths. Almost all the medicines currently used to treat the effects of COVID-19 are produced in the Russian Federation. Of the 16 approved by the Russian Ministry of Health, only two are not made locally. Our manufacturers are now working hard to ensure that the country is supplied with medicines in sufficient quantity. They were able to reorient their production capacity to produce these sought-after products in a short period of time. For a foreign producer, however, his own country is more important in such situations, and Russia would not be a priority market.

Also during the pandemic, Russia developed its own vaccine against the coronavirus. This shows that integration processes have already begun in the industry, with science beginning to interact with production. Only the newest technologies are already being used in domestic enterprises. By the end of this year, we expect the vaccine to be available from several manufacturers.

— Is there a shortage of highly qualified specialists in the industry?

— This is a long-standing problem in the industry. It has still not been solved for the reason that it cannot be eliminated in a year or two. Good, competent professionals need to be trained in a systematic way over a long period of time. Today, there is a shortage of personnel in absolutely all pharmaceutical production facilities, and the level of education that most Russian universities provide does not allow their graduates to immediately become specialists in companies and work effectively with new products. There is therefore still a long way to go in this area. The training of professionals for the pharmaceutical industry needs to be undertaken now and on an ongoing basis.

— How do you see the future of the Russian pharmaceutical industry?

— As an optimist, I am absolutely convinced that the Russian pharmaceutical industry will become a global flagship in the future. We will definitely be in first place, the only question is how long it will take us to get there. There is great intellectual potential in the country today; our people are not afraid to embark on even the most complex projects. I am sure that the symbiosis between the state support that is currently being provided to the industry and the active participation of business will definitely bring Russia to the forefront of the global pharmaceutical industry.

Interview by Kira Vasilyeva

Original article: https://www.kommersant.ru/doc/4583531?query=%D1%80%D0%B5%D0%BC%D0%B5%D0%BD%D1%8F%D0%BA%D0%BE