President of Russia Dmitry Medvedev: Let’s discuss the situation with medicines. Currently, we are dealing with this issue at various levels including the Commission for Modernisation and Technological Development of Russia's Economy. We intend to pay special attention to developing our pharmaceutical industry. One of our priorities would be drafting a list of strategically significant medicines that must be produced domestically to fully meet our internal demand. That would guarantee our national independence of foreign suppliers.
I have given relevant instructions. Please report on what has been accomplished. We will review other matters afterwards.
Minister of Healthcare and Social Development Tatyana Golikova: Mr President, we initiated drafting a bill on medicines market prior to the establishment of the Commission [for Modernisation and Technological Development of Russia's Economy] and your instructions on determining the list of strategically important medicines. Once the draft law was prepared, it was submitted to the Government of the Russian Federation which will examine it shortly.
I should say the law itself was a difficult one, and the drafting process was not easy, as it involved redrafting or amending numerous laws and regulations pertaining to the medicines market, including government resolutions, orders by the Ministry of Healthcare and Social Development, and everything else regulating supply of domestic or imported medicines to the Russian market.
Dmitry Medvedev: What kind of amendments have been introduced?
Tatyana Golikova: I would say that the first and perhaps one of the most important amendments was a simplified medicines registering procedure which until now has been the major problem for all.
Dmitry Medvedev: Indeed, we hear complaints about it all the time.
Tatyana Golikova: In this regard, I should mention that the draft law specifies in detail the mechanism of the [registration] procedure and the duties and responsibilities of everyone involved therewith. What’s most important is that from now on the law will clearly regulate the various procedures which currently lack proper transparency.
(The Minister further reported in detail on specific mechanisms of medicines examination, approval and government registration.)
I would like to move on to a subject of composing the list of vitally important and most essential medicines. The last time such a list was revised in 2007. Even though it is to be revised on the annual basis, that was not the case, it is therefore imperative now to accomplish its overall revision in line with the legislative amendments and your instructions.
Dmitry Medvedev: How many medicines do we have today on that list?
Tatyana Golikova: At the moment it contains 658 international unpatented medicines and 1,000 brand name medicines. But the major problem with the list is lack of any straightforward principles for medicines selection and acceptance. Given that the medicines on this list must meet certain parameters of standard medical treatment, it must be crystal clear how and why the medicines were put on that list, how efficient they are and what advantages they offer.
Respective analysis will be completed shortly. By now, we have reduced this list to 488 medicines, leaving only the vital ones, as well as effective medicines produced domestically. Based on our provisional list, we finalised suggestions regarding strategically important medicines. Out of the 488 international unpatented brand names, 165 medicines are not manufactured in Russia. Unfortunately, these 165 medicines include ones that can improve the mortality and morbidity rates in Russia.
(Then, Ms Golikova gave a detailed explanation of the criteria for selecting strategically important medicines for the list.)
But it is very important to fully consider the projects which have been suggested within the programme initiated by the Commission for Modernisation and Technological Development of Russia's Economy, the projects aimed at developing the pharmaceuticals industry. We may come up with additional proposals of introducing innovative medicines, rather than merely substituting imported products with domestic equivalents. In my view, this is imperious now, as we regretfully fall behind others in developing original pharmaceuticals.
Dmitry Medvedev: This is indeed very important; you and I will continue working on this issue within the framework of the Commission. I will also comment on the subject in the Presidential Address [to the Federal Assembly].
We have other problems to address as well. Right now, the flu is spreading, and this includes new strains of the flu – ones that we are not currently used to resist. How would you describe the situation in regard to the flu and viral infection epidemics in Russia?
Tatyana Golikova: The level of flu infection is traditional, and it does not really vary from the number of flu cases registered at this same period of time over a number of years. The one thing I would like to note is that the pandemic virus is spreading at a slightly faster rate than we expected, and so the peak of infection has shifted somewhat time-wise, compared to what we see in regular years.
Dmitry Medvedev: In other words, it is occurring earlier.
Tatyana Golikova: Yes.
I must say that we are taking all possible measures and follow your instructions. It has been reported that vaccinations on national scale will be launched on November 9. Pharmaceutical companies have been producing domestic vaccines, and they are ready to continue producing and supplying them. There are three such manufacturers: Petrovax in Moscow, Microgen with two production sites in Irkutsk and Ufa, and the St Petersburg Research Institute for Vaccines and Serums under the Federal Biomedical Agency.
The site in Irkutsk produces a live vaccine, while the others manufacture an inactive one. We are ready to start deliveries of the live vaccine tomorrow, as its clinical check studies were completed. Vaccinations with the live vaccine will begin on November 9 to cover employees of such major industries as transportation, communications, housing and utilities. Then, healthcare employees will be vaccinated with the inactive vaccine, same as children who will get vaccinations in late November or early December.
As of the end of the day yesterday, we received requests from 14 federal entities of the Russian Federation, for the delivery of 774,000 doses. We will begin with the regions where the epidemic threshold has not been surpassed and that as a rule border those regions where the threshold has been surpassed already, to thus build a kind of shield against the spread of infection.
Further to the issue of supplies of pharmaceuticals, I must bring up another related problem. Regretfully, we have observed speculative tendencies on the medicines and protective products market. Last Monday, I met with medicines manufacturers, and all of the manufacturers of the medicines recommended for flu prevention and treatment confirmed their ex-factory prices have not grown, therefore the price hikes we now observe are mainly originating within the products distribution networks. The meeting was attended by representatives from major pharmacy chains, and I warned them that unfair play on this market will end badly for the players, since profiteering on people’s health is the worst sin of all.
Dmitry Medvedev: You have warned them, and I, in turn, will instruct the Federal Anti-Monopoly Service and the Prosecutor General’s Office to closely monitor these processes. If any ill-intentioned actions are uncovered, criminal proceedings should be instigated, because we cannot beat around the bush any longer.
Indeed, capitalizing on the epidemic is a flat-out crime, one that absolutely should be punished. I emphasise that chief executives of such companies must be subjected to criminal rather than civil prosecution, as the necessary legislation for such action is already in place.
Our Ukrainian neighbours face a major epidemic now. They have requested our assistance. Can we assist them in any way?
Tatyana Golikova: Yes. We discussed this issue at the Cabinet meeting yesterday, and a decision was passed. Today, I need your approval for it. Next week we will be able to supply to Ukraine 200,000 packages of Arbidol which is an anti-viral medicine.
Dmitry Medvedev: An immunomodulator, to my knowledge.
Tatyana Golikova: Yes. We have coordinated the deliveries with the Ukrainian officials and now we will need to have the logistics and technicalities sorted out to be able to make the delivery next week. The Ministry of Emergencies is ready to take care of it. Respective Cabinet instructions are now drafted and once issued, humanitarian aid will be provided.
In addition, we have offered to send, if necessary, our specialists to Ukraine. Our doctors may travel there to help carry out medical tests or we may check the strains here in Russia.
Dmitry Medvedev: We must help our Ukrainian friends curb this epidemic.