The law is harsh...

Tatiana Golikova: "The new law makes the procedure of registration of medicines transparent at all its stages" Ministry of Health and Social Development of the Russian Federation

The President of the Russian Federation Dmitry Medvedev signed the law on the circulation of medicines. The law will come into force on September 1, 2010.

At the meeting of the President of the Russian Federation Dmitry Medvedev with the head of the Ministry of Health and Social Development Tatyana Golikova, it was discussed how the norms of the new law will work in practice.

Minister Tatyana Golikova stressed that, first of all, "the law makes the procedure for registration of medicines transparent at all stages, now this procedure should take up to 210 days." Until now, some, especially domestic drugs, have been registered for years.

"The law strictly regulates that imported drugs undergo the same registration procedures as domestic ones, except for clinical trials on volunteers," the Minister said. She explained that Russia establishes mutual recognition of clinical trials of medicines with other countries if there is a corresponding bilateral agreement.

The law describes in detail the process of international drug research. Thus, foreign medicines can undergo research in Russia, and thus, domestic specialists get access to foreign developments in the field of drug research.

"We managed to find a consensus with domestic manufacturers on the final date of transition to the GMP quality standard – from January 1, 2014," the head of the Ministry of Health and Social Development said.

She explained that such a delay is due to two factors. Firstly, there are "a lot of cheap familiar drugs in Russia that do not have this standard, and they cannot be removed from the market at once." Secondly, "manufacturers should evaluate plans for modernization and reconstruction of production facilities in accordance with GMP standards."

Tatiana Golikova said that manufacturers propose to develop a federal target program that would support the pharmaceutical industry with a gradual transition to the GMP standard from 2011.

The Minister drew attention to the fact that the new law prescribes mandatory monitoring of the safety of medicines for the first time and fixes the responsibility of pharmaceutical market participants at all stages, which will help prevent the falsification of medicines.

Regarding orphan drugs, the head of the Ministry of Health and Social Development stated that there are no restrictions on these medicines in the new law:

"Orphan drugs can be treated according to general rules, there is no prohibition."

Excerpt from the transcript: 

Dmitry Medvedev: First of all, I would like to inform you that I have signed the law on the circulation of medicines. The law, which was discussed for a long time, was discussed quite emotionally, different points of view were expressed. But the law has been passed, it is subject to execution, especially since today at a Government meeting, as far as I understand, you will also discuss the situation in pharmacies, drug prices. And these two points, that is, the new regulatory framework and the actual work on the pharmacy network, on the availability of medicines, will need to be linked together. Let's talk about this now, especially since, once again, the discussion about the law was quite emotional. And they wrote to me about certain categories of drugs. Maybe you can briefly tell me what you intend to do.

T.Golikova: Thank you. Dear Dmitry Anatolyevich, the law really has a long-suffering fate, because the first law was adopted a long time ago and, in fact, did not meet modern requirements for a long time. And the modern law, which is now in force, since the newly adopted one is supposed to be introduced from September 1, 2010, the modern law on very many sensitive problems of the drug market contains only general norms or framework norms, without answering specific questions. In particular, for example, by-laws of the Government or, even worse, by-laws of federal executive authorities do not regulate some issues related to the registration of medicines and the collection of fees for all stages of registration of medicines. And now the law completely closes the registration procedure at all stages, it harmonizes the timing of registration of medicines with European legislation. Now full registration will be a maximum period of up to 210 days. We have concretized …

Dmitry Medvedev: And, excuse me, how many drugs have been registered before – just like that, for example?

T.Golikova: We have different ways. Some – for years.

Dmitry Medvedev: For years. And people were really waiting for them?

T.Golikova: Yes. And, unfortunately, I have to state that to a large extent this applies to domestic medicines, since they completely go through the entire procedure from beginning to end with all the problems that they encounter along the way. Why I emphasize this is because the very next point in the registration procedure that I wanted to mention is the procedure for conducting clinical trials.

And accordingly, the differences that exist today when conducting clinical trials, when registering our drugs and imported medicines, exist both in terms of timing and procedures. And therefore, we have strictly prescribed in the law that imported medicines that enter our market undergo all the same procedures, with the exception of the first phase of conducting clinical trials on volunteers. And we also introduced for the first time into the law a norm according to which mutual recognition of clinical trials is carried out if there are bilateral agreements. This is very important for us: in principle, for those organizations that conduct clinical research, and in general for the pharmaceutical market.

In this regard, one more point regarding clinical trials. It is connected with the fact that we have prescribed in some detail the procedure of so-called multicenter international clinical trials, which enable foreign manufacturers, entering our market, to conduct clinical trials on the basis of our medical organizations. And accordingly, as a consequence, this leads to the fact that our specialists, among other things, get access to those developments on which clinical trials are conducted.

Another topic that was also very hotly discussed, and in the second reading we found a consensus approach, as it seems to us, with our domestic manufacturers. We have prescribed the final deadline for the transition of our enterprises to the appropriate quality standard, the so-called GMP standard. And we have determined the end date of such a transition with the corresponding transitional provisions as January 1, 2014. Why was this deadline determined? There are two circumstances here.

The first circumstance. We have drugs that are cheap, affordable, familiar to our population, which are produced at enterprises that do not have this quality standard today, and it is not possible to remove them from the market at the same time today.

And the second point. Our domestic manufacturers should clearly assess their capabilities and plans for the restructuring of production, its reconstruction and bringing it into compliance with the requirements that will be indicated in the relevant by-law according to such GMP rules. And I must say that almost all domestic manufacturers have expressed the wish that the instruction that was previously given by both you and the Prime Minister on the development of an appropriate federal target program since 2011 to support the domestic pharmaceutical industry and the industry of medical devices, including in order to be one of its possible The segments were this gradual transition to the GMP standard.

The third topic that I should focus on is the topic that was outlined in your long–standing order to ensure the availability of medicines in rural areas. The bill allows, the law now allows, where there are no pharmacies, to sell medicines in outpatient clinics, in centers and departments of general practitioners, paramedics, paramedic-obstetric stations and so on.

Dmitry Medvedev: I remember this story, it appeared probably three or four years ago, when we started to re-create FAPs [paramedic-obstetric stations], we started to travel through them, and they are not allowed to sell medicines there. And grandmothers just turned to me, said: "Why can't we buy medicines here?" So now it is directly established in the law?

T.Golikova: Yes. And also, of course, the bill introduces a norm according to which state regulation of prices for the list of vital and necessary medicines is carried out. And the norm that you spoke about at our last meeting has been implemented there, that every region of the Russian Federation is obliged to provide information in an accessible form on the Internet and in all pharmacy institutions at what prices medicines are sold in the relevant subject or the relevant municipality of the subject of the Russian Federation.

And, probably, if we talk about major changes, we should also pay attention to the fact that for the first time such an important component as monitoring the safety of medicines, the so-called pharmacovigilance, is prescribed in the bill. To date, the current law regulates the issues of working with counterfeit medicines very poorly, and therefore this topic has also been reflected there. At all stages, it is assumed that all participants in the pharmaceutical market are responsible for the stages in which they participate in the circulation of medicines. At the same time, we are making, in agreement with the Parliament, another small bill that amends the Administrative Code, eliminates those gaps that are related specifically to the work of pharmaceutical market participants and the responsibility of these pharmaceutical market participants for certain actions.

Dmitry Medvedev: I see. But in fact, it seems to me that the topic that you have outlined is also very important – on the supervision of the pricing procedure. If I understand correctly, then in this case these prices, which should be available to almost any interested person, can be viewed simply through a computer using Internet capabilities - and see how much the medicine really should cost, and whether there are deviations in a particular pharmacy, for example, in a higher direction, because it is unlikely that there will be deviations to the downside against what exists on the market.

T.Golikova: Yes, this is a mandatory requirement, which officially comes into force on September 1. Now we strongly recommend them to do this and ask them for it, and since September 1, this is already the norm of the law.

Dmitry Medvedev: I see. And there were a lot of appeals to me on individual drugs. Is there any ground under them, Tatiana Alekseevna?

T.Golikova: We work and are very familiar with this topic – and we work with non-profit organizations that work on the topic of so-called orphan drugs. And I must say that the law, in the part related to the import of medicines, with the acceleration of the procedure for obtaining permits for the import of these medicines, gives an answer. We have clearly established that within five days such a permit is issued and certified with an electronic signature, that is, you do not need to move to Moscow in order to get this permit. This is the first moment.

And the second point. Nevertheless, the law does not regulate the circulation of orphan drugs, because orphan drugs are a derivative of the definition of rare diseases, which should be given in legislation called "Fundamentals in the field of Healthcare", which we are also working on now, updating it, in accordance with your instructions.

Dmitry Medvedev: So what is not regulated means that they can apply according to the general rules, and the law does not impose any ban on them?

T.Golikova: The law does not impose absolutely any prohibition.

Dmitry Medvedev: All right. Because, after all, there are always people who are worried, and even more so it concerns health, so you need to treat this very carefully.

thank you.

For reference:

The Federal Law provides for a change in the legislative regulation in the sphere of turnover of medicines, affecting, in particular:

• issues of state regulation of prices for medicines;
• organization of the system of circulation of medicines, procedures and terms of their examination;
• issues of state registration of medicines;
• formation of a unified state pharmacopoeia;
• procedure for conducting procedures for clinical trials of medicines;
• issues of accreditation of medical organizations participating in clinical trials;
• requirements for the seizure and destruction of substandard, falsified and counterfeit medicines;
• issues related to ensuring the availability of medicines for the rural population;
• the procedure for the import of medicines.

The Federal Law specifies:

• conceptual framework (taking into account international practice);
• powers of federal executive authorities and executive authorities of constituent entities of the Russian Federation;
• requirements for quality indicators of medicines and their labeling;
• the procedure for the circulation of medicines for veterinary use and other.

The Federal Law provides for the responsibility of subjects of circulation of medicines for violation of the requirements established by law, and also defines:

• the concept of a list of vital and essential medicines;
• the procedure for the examination of medicines by the federal state budgetary institution of the relevant authorized federal executive authority;
• the procedure for conducting an ethical examination;
• rules for the organization of production and quality control of medicines;
• rules of wholesale and retail trade of medicines, manufacture of medicines in pharmacies;
• the rights of patients participating in clinical trials of a medicinal product for medical use, as well as the procedure and conditions for compulsory insurance of their life and health.