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Medicine Circulation

The IX St. Petersburg International Legal Forum discussed issues of selling medicines via Internet, electronic prescriptions, intersubstitutability of medicines, medicines circulation and GMP certificates.

The discussion was moderated by Ivan Glushkov, Deputy General Director at STADA. The speakers were Sergey Kuchushev, Head of GR at Ozon,  Elena Maksimkina, Director of the Department of Drug Supply and Regulation of Medical Products at the Ministry of Health of the Russian Federation, Timofey Nizhegorodtsev, Head of the Department for Control over Social Sphere and Trade of the Federal Antimonopoly Service of the Russian Federation , Alexander Panov, Head of Commercial Practice / Health at Pepeliaev Group, and Vladislav Shestakov, Director of the State Institute of Drugs and Good Practices.

According to Vladislav Shestakov, today there is a global trend towards more stringent requirements to the quality of medicines; this stands equally true for advanced innovative medicines in the development stage. ‘Our inspectors inspect manufacturers of medicinal substances. There was a question ‘In case specific legislative amendments are enforced upon, but not limited to inspectorates and substance manufacturers, should we expect any issues due to constraints on substance supply or disruption of supply?’ This is not going to happen. We are well-prepared to deliver on the entire scope of work planned during the year. This is not going to claim a lot of our efforts, and a dedicated team is already there’, – the expert said.

Vladislav Shestakov also noted that at present preclinical and clinical trials constitute one of the key challenges in Russian pharmacology. ‘Today the quality of portfolio is a risky aspect for Russian companies pursuing development and entering international markets, which implies conducting preclinical and clinical trials. Those who have faced this challenge know in practice that once they apply for registration of medicines in EU or other countries, regrettably, Russian preclinical trials are declared invalid. In order to tap our export capacities, we will have to meticulously ensure preclinical due diligence,’ Vladislav Shestakov added.

In turn, Alexander Panov referred to software as a medicinal product. ‘Otherwise there is no chance of having any significant diagnostic solutions. Currently developers working in Russia accumulate substantial export capacities to produce competitive AI-powered products for medical diagnostics. Different regulatory practices are so largely needed in this area. The Unified Healthcare Information System (UIS) is another extensive topic that is bound to shape the agenda,’ the discussion participant explained.

Elena Maksimkina suggested considering this system a supporting draft law that is bound to improve quality of diagnostics and medical aid, as well as to monitor efficient use of resources. ‘It is easy to commercialize and, thus, destroy; in contrast, it is difficult to enforce things that no one normally wants to comply and that will not commercialize. Moscow used to have minivan drug stores. Those were very convenient. You could buy medicines from such a minivan at railway stations. No drug store, nothing else is needed. Eventually, can you imagine the storage conditions for bifidobacteria?’, she said.

In his turn, Timofey Nizhegorodtsev suggested that digital technologies cannot turn into an absolute and apparent good for pharmacology. ‘We are discussing ambitious plans and goals. At each and every conference we are talking about a breakthrough scenario of a new life powered by digital technologies that generate no good themselves. <…> The title of the Forum plenary session is ‘The Art of Law’.  Law being an art implies, among others, that though a law is already there, it does not arrive immediately at once. How is it possible? Do indicate that delivery is permitted for remote sale of medicines. The president’s task has been fulfilled. However, then you elaborate that in order to provide for remote sale of medicines, medicines shall be delivered by a pharmacist with 35 years’ experience and preferably a doctorate degree,’ he clarified.

Concluding the discussion, speakers took questions from the audience; one question addressed reimbursement for purchased medicines and the relevant procedures. ‘As soon as private health insurers already reimburse for these expenses and – as far as I think – once reimbursement is included in the obligatory medical insurance plan, the amounts will not be large. If the amount is not large – let’s say 5000 RUB, as it stands now with many private health insurers – will this be a sufficient impetus for patients to buy generic medicines of all other medicines in drug stores. Possibly, though, if the year maximum reimbursement remains like that, patients are unlikely to be able to pay for original medicines,’ a member of the audience asked.

According to Elena Maksimkina, the reimbursement plan will not provide for some fixed amount; it will rather be calculated as a specific percentage.

In reply, Timofey Nizhegorodtsev expressed his opinion that all insurance systems are now trying to demotivate consumption of original medicines in the presence of generics. He recommended not to establish a system that could provoke such a scenario.

In her response to these recommendations Elena Maksimkina noted that be it a 100% reimbursement, it always implies reimbursement for a reference price. ‘We are therefore determined to improve the information system and analytics in order to have a well-operating reference pricing system; otherwise it will be very difficult for us to identify the maximum price reimbursement level. According to these mechanisms – and this must be followed through – reference pricing is applicable only to Russian-made products. This point is pivotal, because all countries implement protectionist policies to protect domestic industries’, she noted.

St. Petersburg Legal Forum takes place 14 to 18 May, 2019 in the Eastern wing of the General Staff Building, State Hermitage. SPBILF is supported by the Russian Federation President and organized by the Ministry of Justice of Russian Federation.