It is not only the impact of the pandemic, this is how I hope the changes to get rid of tough administrative barriers in the interests of the patient. And they seriously hope that the new leadership of the Ministry of health heard treatment patient communities and opinions of expert organizations. Perhaps the health system will no longer be cold as an accountant, focused on budget savings, and will focus on improving the quality and accessibility of health care.
a number of decisions already adopted another package of legislative acts and drafts of normative documents is now either in preparation or at the stage of consideration. Discusses changes in the resolution “the third wheel”, which imposed barriers to access of foreign companies to public procurement, if similar drugs are produced in Russia or the countries – members of the EAEU. Practice has shown that it has caused more harm to the economy and patients, and the health care system as a whole. Because, first, excessive preferences reduce competition in the market and disappear as a result of the ability to reduce prices and improve terms of supply. Second, unfortunately, the Russian drugs of a copy does not always correspond in efficiency to the original drugs and the high standards that they apply to the patients, despite the fact that the active ingredient in them could be the same. But either included in their composition other substances or characteristics of the production could be very different. As a result, the number of side reactions and the overall efficiency of the application could also show differences.
due to the failure of the drugs to which patients are accustomed to, there were complaints, handling of patient organizations. This applies, for example, preparations from cystic fibrosis, diabetes, HIV etc. to Provide all these issues at the planning stage of procurement was impossible, but the rule “the third wheel” the result was a virtual ban on the purchase of the original and other necessary preparations, which, as shown, does not refuse.
at the same time barriers for original products, we actively introduce the concept of interchangeability. But it is generally quite risky, and its combination with additional preferences for the Russian manufacturers of generic drugs without consultation with doctors and assess the real needs of patients create very serious risks for patients.
in addition, the resolution provided an opportunity to soften the requirements for the auction price of Russian drugs relative to the foreign counterpart. The result is often the price of Russian drugs was close to the price of the original. And sometimes even exceeded them, although foreign drugs have gone through all cycles of clinical trials (CI).
As generics, as you know, are a shortened cycle in which to identify all the side effects difficult. The result was that economically we almost won nothing.
I am far from thinking, that all Russian generics are bad, sometimes they can be even better than the original drug because it is synthesized for new technologies. But in each case it is necessary to analyze and prove because to experiment on the most vulnerable segments of the population – to patients, especially patients with severe disease cannot. Namely these categories are the beneficiaries, for which drugs the state purchases.
the Second major change that we see today and which can improve the situation is the resolution of purchasing medicines by brand names. Such a possibility theoretically existed before (within the list of medicines procured in accordance with their trade names). But the procedure was not transparent and not actually worked (for 6 years this list has not been a single product). Now it is proposed to establish an interagency Council under the Ministry of health of Russia for the formation of such a list. But change the name of the procedure does not work, it is necessary to clearly prescribe the criteria for inclusion, to bring to consideration of the applications of clinical pharmacologists, a healthcare, professional medical organizations and patients, public organizations – by analogy with the approach to the formation of EDL. It is, of course, about big government spending, so this is a great and very humane step towards the interests of the patients. Therefore, in order to eliminate the subjectivity and to improve the quality of care definitely need some kind of insurance mechanism. I want to believe that in this configuration it will run successfully.
Even more important is the decision on the establishment of a unified register of patients who have benefits. This solution is prepared with the end of 2018, when the question of the transformation of the preferential provision of medicines was discussed at the meeting of the state Council. Analysis then showed how the current version fails a combination of Federal and regional benefits. The big problem was that it was impossible as an individual to trace the volume of intersection of these benefits. People who monetized their Federal benefit received and the regional government regulation No. 890, that is, in fact, received state obligations on two grounds. The result was washed out money from the Federal system of preferential lambasruchei and regions bear additional financial burden. In addition, decrees of the��s No. 890 badly out of date.
on the one hand, there are a number of life-threatening or debilitating diseases for whom at this time, a pathogenetic treatment, but patients must wait until their condition deteriorates so much that it will be rated I or II non-working group of disability to get a cure. It is obvious that there is a need to update the list of diseases under order No. 890. On the other hand, court decisions show that often the regions are forced to Finance individual beneficiaries at the expense of other patients. And it’s not just a very difficult situation for regional economies, but also puts citizens in unequal conditions depending on what the situation with the incidence of folds in the region. So, one patient with an expensive orphan disease can consume up to 40 percent of the total budget for provision of medicines in the region. The establishment of a unified register will allow to solve two tasks: first, to regularize the situation with the provision of regional benefits. Second, to provide all beneficiaries of the drugs in the amount not less than the Federal essential drugs List, whereas now in the regions, the lists are often much smaller.
in addition, the decision to register will allow you to assess the scale of the intersection and take the next steps, which, in my opinion, can only improve the position of privileged categories. You need to offer the public an environment that would be better than is available today and would allow each volunteer to choose another, can be integrated, providing system benefits.
There are a number of regulatory norms that need to change in the interests of the people. So, needs to be revised the concept of formation of prices for medicines. There is a strange model of reference pricing – select the minimum prices of the 4 methods, and further reduction in public procurement leads to the simplification of drug therapy does not solve tasks in more effective treatment. It is necessary to improve the inclusion of innovative medicines on the EML. In fact, this order today is prohibitive to innovation, because it evaluates only the direct costs of the health budget on a new medication. And all the benefits from their use were most often lie outside the health system and reflect the benefits of the General economy. System procurement planning from the achieved, nothing to do with patient registers, which are all features of tactics of treatment is archaic. Today, when you move to personalized, effective medical care to use it is wrong. Planning of public procurement should proceed on the basis of registers, which should be described in detail treatment kato each patient. No less important is the centralization of the procurement of orphan drugs in the wider than now, the list, because the bigger the volume purchases, the higher the guarantee provider under the terms of the supply, and the easier it is to negotiate about the possibility of lower prices. To work from a position of strength, i.e. to make producers either forced to reduce the price or to pay 20 percent of total sales potentiodynamic products in R&D, as is now being discussed in the Ministry of economic development, I personally think is a strange tactic. Don’t forget that our market is often 1-2 percent of the portfolio of innovative manufacturer, we therefore need to engage in constructive dialogue and to negotiate. Any other acts destructive.
Matthias Wernicke, CEO of Merck in Russia and CIS, member of the Board of Directors of the Association of international pharmaceutical manufacturers:
– We are often faced with a situation that, despite the status of interoperability in GRLS, drugs with one of MNN show different clinical effects and safety profile. This is due to such factors as the quality of the substance, the technology and quality of production, logistic conditions. Confirmation of this we see in the recently adopted government decree No. 965, according to which patients can be treated as an outpatient with the same drugs as in hospital, one trade name. Appearance of order is due to the fact that they have become aware of the real situation in hospitals when patients were treated with drugs alone, and at discharge they received counterparts of other manufacturers, which would not give the same effect.
This initiative is relevant in public procurement in light of the need of execution of the order of Ministry of health of the Russian Federation of may 10, 2017 No. 203н “On approval of criteria for evaluating the quality of medical care.” It States that medication should be given instructions on the use of drugs, age and sex of the patient, severity of disease, presence of complications of the underlying disease (condition) and other related diseases. In this case, if the attending physician is responsible for the implementation of the requirements, he should be entitled to decide what medication will be purchased at a healthcare facility and this can only be done using the trade name of the drug. But not to do it haphazardly and have the ability to control justification for the procurement may serve as the specific requirements/criteria such as the availability of comparative studies, sufficient data on safety.
Yury Mochalin, Director of corporate Affairs of the company “Sanofi” in Eurasia:
Essenceproviding the system of procurement of drugs aimed at maintaining the competitive environment within the same INN, that is effective for reproduced products. And most of the discussed legislative developments in this area aimed at improving the current approach to public procurement, but does not affect the basic principles. In our view, considerable potential for the development of the system can be expanded through the development of individual approach to the procurement of innovative medicines that have no analogues within the same INN. Normal competitive procedures cannot, in this case lead to competition and efficient use of public funds.
At the same time, now no doubt about the need to strike a balance between generic and innovative drugs in the healthcare system. After all, in order to solve facing Russian healthcare ambitious goals, innovations are simply necessary. As a more cost effective alternative to the auction procedures with respect to innovation could be considered world’s best practice in direct negotiations with manufacturers, contracts with risk-sharing or payment by the final result.
Alex Savenkov, Director for interaction with public authorities in Russia and the CIS, the company “Johnson &Johnson”:
– Pandemic tested the existing approaches in health care and reiterated the importance of flexibility and openness to improve its sustainability. At the highest level, there is an active discussion of the possible transformations in the sphere of public procurement of medicines. In our view, special attention deserves the process of procurement of innovative products. In this regard, it is necessary to continue the dialogue and implement modern approaches to pricing and reimbursement of innovative procurement of medicines, to consolidate the possibility of direct negotiations between producers and government, as well as greater use of innovative contract models. These tools can increase the availability of innovative therapies for patients and to promote a more rational use of health resources and budget optimization.
