Lawyers and pharmaceuticals: SPBILF discussed accelerated registration of medicines

Saint Petersburg International Legal Forum has held a session on accelerated registration of medicines for viruses. The speakers have shed light on the future of that issue.

State regulation is now one of the key issues for production of medications. Alexey Repik, Founder and Chairman of the board, R-Pharm group of companies, Chairman of Delovaya Rossiya, All-Russia Business Association, said: «Our regulators, which have always been very conservative, and this is true for the Health Ministry, Federal Service for Surveillance in Healthcare and Ministry of Industry, managed to act faster than their foreign counterparts and adapted their regulations and procedures to accelerate the decision-making for the sake of COVID 19- positive patients. This speed deserves a lot of respect and may serve as a best practice for most of the countries worldwide.»

Aleksey Alekhin, Head of the Department of Pharmaceutical and Medical Industry Development, Ministry of Industry and Trade of the Russian Federation, believes that there are no major issues with production in the Russian medical industry. The companies are carrying out their plans, localizing production of pharmaceutical substances, which have never been Russian made before. But some of these substances are still imported from abroad.

«We see that some pharmaceutical networks record a temporary peak demand for certain drugs that have been advertised before either on TV or in social media. People overreact to that, they go and buy a big stock of these medications, something the effective legislation does not prohibit in terms of quantity. What we can do is keep track of such situations along with the distributors. That’s what we are doing on a daily basis», – he said.

The authorities are now working out some documents to accelerate the medicines’ expert evaluation and registration. Filipp Romanov, Head of the Department for State Regulation of the Circulation of Medicines, Ministry of Health of the Russian Federation, told about that.

«First of all, we provided for an opportunity to reduce the time for expert evaluation, when the lab testing can be replaced with the ones, used in civil defense. These are the most time-consuming evaluations and tests, that cannot be cut in time for technological reasons. <…> we are also shifting to digital document exchange. One of the major advantages is letting the applicants certify their documents», – he said.

Speaking on behalf of the Ministry of Health, he said that the main objective now was to equip the doctors with all the possible medications. Besides, the manufacturers will be allowed to introduce changes to the formulae without extra evaluation and tests. 

The pandemic boosted online technologies, the medical industry being no exception.  Though it is obvious that digital is not always applicable for the sphere of health.  «Telemedicine has now become the main means of prophylaxis and a channel to communicate to doctors, as many countries have introduced a lockdown, barring their people from leaving home. Where the quarantine is not so rigid, the patient are still reluctant to go out, once their condition is not life threatening. It probably would make sense to take care of the patients, who, say, need an injection, with the help of nurses, who can come and do it. Such programs are being introduced in Europe», – Aleksey Belozerskiy, Head of Legal Function for European Clusters, Novartis Oncology, said.  

Still, the speakers believe we shall not be forgetful of existing rules and norms, even amid the pandemic. «It is of paramount importance not to give way to panic and forget in the name of big cause that there are rules, that we have to act in the framework of evidence-based medicine, that there are procedures to be followed. There is a fine line between the necessity to ensure the quality of the process and breaking the registration procedure», Alexey Repik said.

Some countries, bearing in mind the situation at hand, have introduced relatively rigid measures. Some are restricting the export of medications. Switzerland, for instance, in an effort to address shortages, prevents people from buying a stock, allowing only one piece of cough syrup per person.  The panelists have commented on measures, taken by the Russian medical industry to combat the coronavirus.

«Ensuring that the patients in Russia have all the necessary is the task which unites big and small manufacturers, authorities, regulators, distributors and retailers. We may say that so far it seems that the kind of interaction between the market players and the authorities helps us to solve problems quickly and effectively. <…> It is obvious that the first steps in that direction are apparent and precise», – Ivan Glushkov, STADA Deputy General Director said, concluding the discussion.

St. Petersburg International Legal Forum 9 ½ : Rule of Corona is held on April 10 through April 12 via video conferencing. It brings together Russian and international authorities, lawyers, academics, politicians and journalists. The Forum focuses on legal aspects of public and business life amid COVID 19 pandemic.