A Health Ministry Committee on the special lists of medicines did not include 24 drugs to the List of Essential medicines (ZNVLP) and medicines for special social categories of people (ONLS) for 2017. As a result, representatives of patient, physician and pharmaceutical manufacture communities invited the Ministry of Health to the open dialogue. A press briefing on a possible pause of those medicines took place in the ITAR-TASS press center on November 25. As a result, the Committee put on hold 24 drugs
First of all, there is a concern among patients regarding the potential pause of the addition of some medicines to the Lists. According to Co-Chair man of the Russian Patient Union, Yan Vlasov the Committee evaluated 160 names of medicines of which the Patient Union was able to successfully advocate only for 20 from the ZNVLP list and 10 from the ONLS. Also, the community has many concerns regarding the transparency of the evaluation process. Over a half of 26 Committee members are Health Ministry officials. Mr. Vlasov also noted that there must be a recycling of the lists with the removal of old and ineffective medicines and the addition of new innovative drugs. “Patients are waiting for medicines. We hope that it is still possible to fix the current situation and make the process more transparent. The patient community will do everything possible to be heard,” Yan Vlasov.
Acting Director of the Russian Union of clinical oncology RUSSCO, Ilia Timopheev also spoke about the difficulties that cancer patients will face if the preferential Lists would get suspended. Patients will lose access to medicines for the treatment of sarcomas, late stages of lung cancer, melanoma and other. There are only five medicines of that kind and only 1000 people need them, therefore, the healthcare expenses, if the drugs were included, would not be significant. “We hope and ask to continue the work on expanding the preferential Lists.”
Drug manufacturers also have their concerns about the way the lists are formed. “Import substitution in pharmaceutical industries is one of the most successful, however, there is less and less trust in it since the rules are being changed along the process. Foreign companies that have allocated their production in Russia and passed all the quality control checks were at the end put on hold to be included in the ZBVLP list. This decision brings additional investment and eruption risks. A healthcare system highly depends on the state of a local pharmaceutical industry and on the level of trust to it. The issue that we are faced with today will not only limit patient’s and investors trust but also will affect implementation of the Pharma 2020 strategy,” ARPM Director General, Victor Dmitriev.
Acting Director of the AIPM, Vladimir Shipkov agreed with his colleagues noted that not only patients are concerned about the accessibility of modern effective medicines, but also producers without respect to their national origin. He also drew attention to the pause of registration of new medicines that were produced outside of Russia. “We acknowledge that due to registration inconsistency none of the AIPM many members were not able to submit the application to register a new drug. According to our analysis inclusion of 20 medicines out of 24 to the ZNVLP list will allow the State to save 600 million rubles annually. Companies that are submitting their applications confirm that they are willing to lower the price at least twice a year (at registration and during auctions). Therefore, according to the decision made by the Health Ministry Committee, those medicines that are placed on hold now should be included in the ZNVLP list. We hope to get the ZNVLP and other preferential medicine lists to be updated by the end of 2016,” Vladimir Shipkov.
Head of Department of drug provision of the Health Ministry of Russia, Elena Maksimkina reassured patients and drug producers. “The ZNVLP list is integrative. It is the medicines from the core part of the list that are intended to provide each person with the minimum to treat the main nasologies. The approach to form the list has been changed in the last few years. Now medicines are being chased based on their clinical effectiveness and economic criteria. During the last 2 years, 96 new medicines were included in the list, and a big part of them are for oncology patients, which are expensive.”
The task of the Health Ministry is not only to include a medicine to the List but also to guarantee its physical and economic accessibility. According to Mrs. Maksimkina, after the rejection of several medicines the Ministry received over 30 proposals from the companies to reduce the price of those medicines. This will be considered at the Committee meeting. The Committee evaluated 153 medicine. At the last meeting, it was decided to put on hold the decision about HIV and Hepatitis medicines because there is a consultation with the Ministry of Industry and Trade to reduce the price on those medicines.
Members of the conference agreed that the dialogue between the industry and the state will help to avoid further misunderstanding.