TIMOFEY NIZHEGORODTSEV: OUR GOAL IS TO INCREASE AVAILABILITY OF ORPHAN MEDICINES
Participants of the Expert Council on circulation of medicines, development of pharmaceutical and medical industry of the State Duma Committee on health protection discussed financial aspects of medicine provision for patients with rare diseases
During his speech Timofey Nizhegorodtsev, Deputy Head of the FAS Russia spoke about the problems of different levels of patient’s access to different groups of orphan medicines and ways to solve them.
It should be reminded that today there are four groups of orphan medicines:
- included in the lists of vital and essential medicines (VED) and high-cost nosologies (HCN), purchased centrally funding from the Federal budget;
- included in the list of VED, prices are subject to state regulation;
- not included in the list of VED, prices are not regulated;
- not included in the list of VED and not registered in Russia.
“In order to bring together the level of availability of these four groups of orphan drugs for patients, a large-scale work should be done with a detailed description of the goals, measures and steps. This is our common strategic task together with the Russian Ministry of Health,” the Deputy Head of the FAS Russia stressed.
The representative of the FAS Russia also outlined the tasks that need to be solved in terms of increasing the availability of orphan medicines for the population.
The first task is related to changing the work of the Commission on the formation of lists of medicines. Therefore, today the list of vital and essential medicines is formed at the request of manufacturers, and not based on the needs of the health care system.
“We can say that today the healthcare system is forming the list for manufacturer, and not for patient. Although it should be the opposite, - said Timofey Nizhegorodtsev. – We have suggested for a long time that the Ministry of Health of Russia change the geometry of these relations and act more aggressively. If medicines are required to be actively included in the health care system, a whole set of measures should be developed that would allow the Ministry to initiate the inclusion of some of them in the list of VED, regardless of the manufacturer's desire.”
Besides, the Deputy Head of the FAS Russia noted the strategic importance of developing the domestic pharmaceutical industry with a focus, among others, on the local production of orphan medicines.
The second task, which is inextricably linked to increasing the availability of orphan medicines, is the conclusion of long - term contracts for their purchase.
“Now the Ministry of Health has started to move towards the conclusion of long - term contracts and this story needs to be supported and developed, as it allows to additionally “push” the price, get additional guarantees for the stable supply of medicines to patients with rare diseases,” explains Timofey Nizhegorodtsev.
Turning to the task of centralizing purchases of orphan medicines, the representative of the FAS Russia emphasized that authority has always been a consistent supporter of them and has maintained the position that “in general, all work on rare diseases should be concentrated around the Ministry of Health of Russia and its subordinate national medical research centers.”
Speaking about price regulation, Timofey Nizhegorodtsev recalled that a number of preferences for reproduced orphan medicines were adopted at the level of the Russian Government decree. For example, they are always registered as the first reproduced medicines with a corresponding price advantage of 10%. In addition, when prices are revised in 2020, they are not subject to lowering coefficients relative to the prices of reference medicine.
“All this is done in order to minimize the additional risks concerning the possibility of defects in such medicines due to their small production and consumption, as well as to stimulate the interest of manufacturers of reproduced orphan medicines in the Russian market,” said the Deputy Head of the FAS Russia.
He also reminded the audience of the importance of adopting amendments to legislation related to the issue of compulsory licensing, which are currently being approved by the State Duma of the Russian Federation.
“The specificity of rare diseases is that manufacturers almost recognize their consumers, and sometimes they have no motive to register orphan medicines in the territory of the Russian Federation. In order to get access to these medicines, it is extremely important for us to establish and effectively apply mechanisms related to compulsory licensing. This will allow local manufacturers to feel confident and timely cover the risks of shortages in the event of refusal to register or supply the relevant medicines, as well as in the case of "predatory" pricing for them,” underlined Timofey Nizhegorodtsev.
Another important task that needs to be solved as soon as possible is the import of unregistered medicine for the treatment of orphan diseases to Russia. Now the FAS Russia is also involved in resolving such issues, for example, if it concerns disputes related to the issuance of an appropriate permit for the import of such medicines.
“We believe that the mechanism for importing unregistered medicines needs serious modernization. Moreover, this should be done in such a way as to minimize the use of antimonopoly measures, in our case, because all this is additional time and additional bureaucratic costs. It is necessary to make sure that the patient can get the medicine that is required for his life support as quickly as possible,” summed up Timofey Nizhegorodtsev.