«We must have not only an opportunity, but also a mechanism for compulsory licensing. At the same time, it is necessary to clearly answer three questions: when is it possible, what does the patent owner get and who gets it. We, the business, the stakeholder want to understand what criteria are at the core», — Viktor Dmitriev, the General Director of the Association of the Russian Pharmaceutical Manufacturers, has said in his speech at the international conference «Legal Regulation of Modern Healthcare: New Challenges and Trends», organized by the Russian State Justice University along with the Union of the Medical Community «National Medical Chamber» headed by Leonid Roshal.
The change in the regulatory and legal framework requires from market participants a high reaction rate to maintain their market positions. At the same time, the most important issues now are issues related to the registration of new medicines, regulation of pricing and the organization of government procurement of medicines. Among the main factors that have a negative impact on the development of the industry, Viktor Dmitriev has noted the imperfection of the legislative regulation at the industry. «A medicine is at the crossroads of various interests. First of all, this is the interest of patients, but also the one of the medical community, business and government», — he noted. «We are controlled by more than 5 government agencies, which often have different opinions on the same issues. We work under the GXP-standards. The business stands for the establishment of GRP (Good Regulatory Practice), because the «multi-headedness» of the regulator in large measure thwart the market’s ability to provide guarantees and implement the strategy».
As an example, Viktor Dmitriev referred to the Сhapter FL-61 on the registration of an API, where two terms «inserted and included» are used. Customs treats them in different ways, which for business translates into 8% of customs taxes and it is reflected on the final price. After making a proposal for amendments to the Law, a respond came from the State Duma’s Legal Department that the terms are synonymous, and therefore there is no need to amend the Law. «The amendments have now been done again. We have doubts that we will be heard again», — the speaker commented the situation.
The second example of a legislative mishap was the norm associated with Alcohol Market Regulation. We recall, from 01.01.18 FL-171 FL came into force, which assumes that in all enterprises where ethyl alcohol is used it is necessary to install additional equipment and transfer data to the USAIS except for pharmaceutical companies that use alcohol for the production of API. Having said that, the Federal Service for Alcohol Market Regulation (FSAMR) believes that all producers without exception are required to put equipment, which is fraught with additional financial costs, Viktor Dmitriev has noted.
In addition, the speaker made a point of the fact that recently there was a problem with the dispensing of prescription drugs in pharmacies. «As a result, a rigid and systematic work to prevent the dispensing of prescription drugs without a prescription was justified, pharmacists have stopped selling them without prescription. However, there was a problem: doctors have forgotten how to write prescriptions correctly. As a result, the patient does not get the necessary medicine because of an improperly prescribed prescription, and doctors stop writing them out to protect themselves of getting into trouble in a form of a checking».
The range of issues discussed has affected almost all parts of life in the industry. The General Director of the ARPM did not evade the issue of qualified lawyers in pharma, especially since the conference was held within the walls of the Russian State University of Justice: «Unfortunately, we do not have specially trained personnel. We have good pharmacists who do not know jurisprudence and we have good lawyers who do not know pharmaceutics. It’s time to think about the organization of a new faculty for the training of pharmaceutical regulators».
In turn, the Head of the National Medical Chamber, Leonid Roshal, has offered to discuss the issues along with the medical community within the framework of the round table. «It is important to work out a joint strategy taking into account the opinion of all stakeholders», — he said.