Head of Roszdravnadzor — on the benefits of medicine labeling and test purchase operations


Despite the fact that some manufacturers have complained on the difficulties arising from medicine labelling being introduced, Mikhail Murashko notes that a similar system is effectively in place in all developed countries. When buyers are able to verify the legality of drugs while in a drug’s store; why there will be no unlabeled medicine in the market in a six-year time, why regions fall under unscheduled inspections by Roszdravnadzor, who will be affected by test purchases and what problems are caused by Russian citizens not caring about their health – all these issues have been addressed by Michael Murashko, Head of Federal Service for Surveillance in Healthcare, in an interview with a TASS correspondent.

— Mikhail Albertovich, please tell us at what stage the pilot project for the labelling of medicines is at the moment. There are manufacturers who say they have already faced difficulties.

— The project started from those manufacturers who already have their own ideas on labelling, who created their own systems. The main task today is to integrate the entities’ systems into a global system that will collect data from all manufacturers. Technical issues, data exchange format, coordination of all data transfer parameters is now one of the most important and subtle tasks that needs to be addressed. We must configure the system smart and smooth so that manufacturers experience no disruptions since we are talking high-speed and high-flow production where delays are unacceptable.

Another important aspect is wholesalers. In the pilot project, we work with wholesale organizations that deal with the highest volumes of products. It is therefore important that there are no failures at order formation stage and subsequent redistribution to pharmacies.

That is now, in principle, the project is proceeding as planned. When will the buyer be able to evaluate system performance independently?

— Yes, the pilot project is proceeding just as planned. Shortly, we are planning together with the tax service on demonstrating software products and applications that will work for buyers.

If we speak about the volume of data to be available to the buyer, it will definitely be the series number and information on legal circulation (i.e. all quality and distribution procedures are legal), the expiration date and geolocation. The price issue has been solved, too: each drug’s price will be sent to the processing center. In future, we plan to connect this system with the registry of maximum selling prices. The final version will not be available immediately, but we will be launching it phase by phase.

— Currently, how long does it take, on average, a substandard item to be withdrawn from circulation?

— When our laboratories identify problems associated with the quality of the series, we immediately issue a letter detailing the medicine’s series number and name of its manufacturer who has not passed the quality assurance procedure and inform all entities selling this medicine.

To my regret, it is not a quick process; it may take a week, which ultimately, of course, is not quite effective in our rapidly changing world. It is the labelling system that will allow us to respond and take measures quickly, within just a few seconds: you just press a button in the program – and all market participants will be informed and the sale of this lot or batch of drugs will become impossible.

— When do you think our market will be free of unlabeled medicines?

— Today, the project states that starting from 1 January 2019 all newly manufactured drugs must be labelled. The average “lifespan” of a medication is somewhere between a year and two: until it is sold or supplied to a medical organization. The maximum shelf life of medicines reaches five years. Based on these figures, we expect that after the introduction of a mandatory labelling there may remain unlabeled medicines in circulation for another five years.

— And prices for medicines? Many manufacturers continue to say that labeling will affect the cost of drugs. There are still fears that foreign drugs may disappear from the Russian market.  

— You should always try to talk and explain as much as possible, rumors are commonplace in our industry. Practically all developed countries introduce labelling as its benefits are obvious to everyone – manufacturers, regulators and patients. Today, labelling is of interest to all parties. Therefore, it is a benefit and a convenient option both for domestic and foreign manufacturers as all markets should have uniform requirements. Principally speaking, we are prepared to create conditions for domestic producers to enter export markets. The manufacturers themselves are interested in it.

Experience shows us that those waiting until the last minute may just lose and suffer losses because of failing to timely introduce the labelling system. As to prices: a manufacturer can choose what kind of labelling exactly they should apply. It could be a seal on the packaging and a sticker. We are in the same conditions as foreign countries that already have this system up and running. Therefore, our partners and we do not see any principal differences – the main thing is not to delay and to start doing it now.

— Russia is now developing a regulatory framework to protect the rights of socially vulnerable groups of citizens, including, for example, people with disabilities. A number of regulations relate to medications where you need to put the name on a packaging using Braille font. How widespread is it?  

— Well, nothing is new for the pharmaceutical industry. I cannot say it is that widely spread but we have it in the framework of the Eurasian regulation and it is a normal process. Unfortunately, it is a rather exclusive part. Braille is used today by companies that supply their products simultaneously to several markets. Once it becomes a mandatory requirement in Russia, all manufacturers will be there to comply.

— Let us speak a bit more about regulation. Test purchase operations are coming into force as of June. Who will be affected? How will it affect the quality and availability of medicines?

— The adoption of a regulatory act in June is unlikely. Rather — during the autumn session. Test purchase will affect all entities that are subject to control regarding the sale of medical products and provision of medical services. That is the current focus of the project. It will affect, first, the licensing of medical activities, the drug prescription and the detection of unregistered medical products. This is the main task.

— There are criteria for medical care quality assessment, but the result and the quality largely depend on the patient’s commitment to therapy or a healthy lifestyle after a heart surgery. How is it currently taken into account?

— The problem does exist and there is no need to conceal it. A vivid example: one of the patients in Krasnoyarsk had a severe pathology in the heart valve. He had an expensive operation done at the regional hospital. This operation was performed in Russia for the first time. We arrived in Krasnoyarsk, met this patient, got acquainted with the operation results and moved on to get acquainted with the work of this medical organization. And while we were there, we saw this patient in the street with a cigarette.

Do you understand what happened? The efforts of a whole team of doctors were all for nothing because of the patient’s smoking habit. Therefore, we always speak of the necessity of the patient’s responsibility for his/her commitment to medical treatment. The employers have long understood this idea because they need healthy staff: they encourage smoking cessation and there are other programs. Such a practice should exist at the state level, but it should not infringe the fundamental rights of citizens and limit the availability of medical care for them.

— And who demonstrates a more responsible attitude towards their health, men or women?

— If you take the gender structure of the population, the number of men and women up to 35 years is practically the same. A gap starts after 35 years. For women it is a normal desire to look good, to have a healthy baby and to be slim. Therefore, they take more care of their health. For men, such an attitude is either formed later or never since there already is a chronic disease. Therefore, a clinical examination is necessary and a habit to care for their health and this habit should be developed in the family.

There is a joke or an anecdote, when a doctor was asked: “Please, tell me how to live longer?” He replied, “Let’s eliminate everything that shortens the life”. That is, it seems so easy, but how to stick to or how to avoid certain temptations, that shorten life and bring some temporary pleasure? Getting pleasure from jogging is also a good thing.

— If we return to the topic of violations, the mass media tells every month about some cases of medical errors and inspections. What is the usual end for such stories?

— We publish our inspection reports. Yes, it takes time to write a report, sometimes weeks or a month, and the lifespan of data on the Internet is very short. If we talk about recent cases, for example, the one relating to rendering dental care to the girl, then the inspection is already completed and all materials are submitted to the investigation committee. This year alone, we have filed three cases with investigative bodies for further investigation.

Unfortunately, stories occur periodically that cause strong public reaction. I believe that we could avoid all these “heated emotions” by ensuring a proper communication between a health provider and a patient or his relatives. After all, even with the poor outcome associated with a severe disease and unavoidable fatal circumstances, doctors must try to help educate patients.  You need to dedicate time to this explanation.

This communication may be hard for the doctors. Both doctors, patients and journalists write about these stories, should understand that there are today conditions and diseases, or late treatment, when doctors are not able to ensure the preservation of the life or preserve the health.

— When it comes to inspections, what does Roszdravnadzor do?

— In such cases, we conduct inspections, both – desk and on-site. We ask for information about internal investigations.

Today, the system has been formed for conducting unscheduled inspections in the regions. It is built on a risk-oriented approach — we analyze statistical indicators of operational activities that allow us to make a decision that this particular region where medical care and preventive sector are concerned, unfortunately, has failed to achieve the targets including those included in road maps.

This year, unscheduled inspections have been carried out in 12 regions due to the fact that their performance indicators do not meet the requirements of the state guarantees program and the roadmaps, e.g. by demographic and health indicators of the mortality reduction or by the use of cardiovascular surgery, thrombolytic therapy, preventive measures, clinical examination, provision of medicines and so on. When we see that the region did not hit the target by these indicators, this region is immediately included in the list of regions requiring guardianship.

— Another story that resonated with the public deserves mentioning. A couple of weeks ago Deputy Milonov proposed to regulate sex products, in particular sex toys. Should they be licensed as medical devices?

— Roszdravnadzor did not receive any proposals from this deputy and we got no complaints from citizens related to the security or complications because of the use of these products. Should the service receive such a formal paper, we shall consider it in accordance with the legally established procedure.

Source – http://roszdravnadzor.ru/news/7868