The first pilot projects and reduction of the state registration terms for biomedical cell products, laying the groundwork to enable the domestically made pharmaceutical products to circulate on the territory of the EAEU, necessary changes to promote the introduction of telehealth technologies into clinical practices as well as recommendations on the procedure for conduct a quality examination of medical products and promotion of the new technological trends, - the results of the HealthNet workgroup actions on the legislation during one year.
On May 5, 2018, the Prime Minister of the Russian Federation Dmitry Medvedev signed the “Roadmap” on improvement of the legislation and elimination of the administrative barriers in order to implement the plan of the National technological initiative on the HealthNet development.
The document contains the priority measures aimed to eliminate the legal restrictions that obstruct development of the HealthNet market and overall market of medicines and medical devices, as well as Russian companies and start-ups.
In frames of “roadmap”, the HealthNet experts recommended to adopt a range of documents that made it possible to simplify an interaction between the state and scientific and commercial organizations that develop new products. Moreover, these documents enable to strengthen the positions of the Russian companies on the international market, stimulate the creation of new start-ups, and improve the quality and accessibility of medical care, increasing the length and quality of citizens’ life as a result.
What is done?
In a single year, the HealthNet workgroup on legislation elicited the proceeding and adoption of four statutory enactments. The experts consider that the Order of the Ministry of Health № 855н from 7th of December 2018 on amendments is being made to the order of counseling services on issues related to the conduction of pre-clinical and clinical trials of the biomedical cell products. “The dialog between the developer and the regulatory authority is important and even critical, especially for the new innovational spheres, - Mikhail Samsonov, Head of HealthNet workgroup on legislation remarked. – It gives the opportunity to discuss all the details at an initial stage of the project and so that to reduce the time for issuing of the State Registration of the biomedical cell products, because face-to-face consultations complement the detailed written ones”.
The document was adopted in accordance with the point 20 of the HealthNet “roadmap” on legislation improvement.
Why is this important?
“Biomedical cell products are, for example, remedy of burns, - the Head of “Biomedicine” product line of the HealthNet market Andrey Lomonosov says. – Burns over 30% of the body surface can become mortal, especially for children. The use of the cell products makes it possible to cure for burns, even if more than 80% of the skin was harmed.”
There is a range of diseases that could be treated successfully using the cell products. According to Andrey Lomonosov, the domestic project of cells that can replace insulin is under the development.
Living cells produce insulin and can be injected into the human pancreas gland. Imagine one operation and a person do not need to do insulin injections for many years. This is not a replacement therapy, when people are living on injections and spend a lot of money. It could be called a break-through therapy, if we talk about an overall market area.
The cell therapy can be used for the treatment of cancer; likewise, it becomes to be practice abroad, for the treatment of different types of leukemia. “The therapy leads to the long-term survival of patients and their practical healing, - Andrey Lomonosov declares. – There are not so many examples now, but this is a future of medicine.”
What is next?
The Order of the Ministry of Health № 855н allows reducing the development time and systematizing the approach to the development of such medicines. “This is a precedent that was said it is impossible in Russia at all”, - the HealthNet specialists comment.
“Now the medicines developers can communicate directly to the regulatory authority. For example, sending of one written request to the regulatory authority and receiving the reply for it may take up over one or two month. During the face-to-face consultation, it is possible to ask four or five questions, receive an answer immediately and then ask a following-up question, this enables to save at least six month for the development. This makes it possible to clarify many questions like the design of the researches, main requirements and deadlines.”
The first face-to-face consultations have already been held in a middle of the year. “Specifically, such kind of consultations is very important for those products that have no state registration previously. And the developers of these products cannot do nothing without such kind of communication and quick feedback,” - Andrey Lomonosov said.
According to the HealthNet working group, in Russia the companies and start-ups will have an opportunity to develop and launch new innovative products into the market much faster and more effective, because they will not make any mistakes during the preparation of the documents or during planning of pre-clinical and clinical trials.
What do they have?
In foreign countries, the time of creation of such medicines, from the issuing of patent to its registration and entrance into the market, with the consultations of regulatory authorities takes from five to seven years instead of ten or fifteen years. “If we talk about the personalized therapy, and cell therapy is often personalized, the quantity of medicines increases and the speed of the launching into the market grows due to the measures taken by the regulatory authorities in Europe, in the USA, mainly on the basis of consultations,” - the HealthNet working group pointed out.
Future is in the personalized medicine
The USA is the country that shows the fastest growth in the field of the personalized medicine. This leadership is determined by the effect of the CLIA law, which allows the medical use of the diagnostic tests without complicated and expensive registration procedure, - Andrey Lomonosov notes. The HealthNet working group actively participated in the development of the similar document that is currently under approval in Russia. “The personalized medicine does not work without innovational diagnostic tests and in vitro studies, - he highlights. – It could be the tests, aimed at studying of the entire human genome in complex, are very difficult – it is not a mass field. If we are talking about a foreign experience, we can take the non-invasive prenatal diagnostics as an example. It appeared as a test that was developed in the laboratory, and then after many years it received the registration.”
What do we have?
The HealthNet working group experts believe that the adoption of the law, that determines a procedure of arrangement the in vitro trials with use of medical devices, developed in clinical diagnostic laboratory and unregistered in accordance with the established procedure, will significantly improve the opportunity to diagnose the neglected diseases. This range also includes the hereditary diseases and others for which there is currently no diagnosis, because it is simply economically unprofitable to protect the interests of 50-100 patients. “Today we have to register everything. If you use unregistered diagnostic tests, you become criminally responsible, - Andrey Lomonosov declares. – But, if we do not take any measures, do not make steps forward, so, the innovations in our medical field would develop even more slowly than before.”
“In Russia, when patients and doctors hear the words “an unregistered medical device, that can be used,” they get afraid, - he added. – But this is a legal casuistry, this is very important to find a way to regulate such medicines market like in the rest of the world. And here the aspect of audience education comes to the force.”
Why study is so important?
It is significant to promote such fields of healthcare development and brand new technologies. The HealthNet workgroup experts consider that we should not be afraid of something new, but be ready to use it. In accordance with point 5 of the “roadmap” on legislation, the HealthNet infrastructure center approved The Methodological recommendation for promotion on popularization of the technological fields that are in process of implementation in frames of the National Technological Initiatives (NTI), on July 10, 2019. “It will help to lay the groundwork to build trust and demand for new products both among consumers and in the professional community”, - the document says.
As the HealthNet workgroup specialists explained, we are primarily talking not only about in vitro tests, but also about IT technologies and the introduction of telemedicine, for example, remote monitoring of the patient's condition, which may not go to the doctor, but the doctor, meanwhile, receives all the necessary data about the patient's condition.
A real example of the effectiveness of such projects, which are already successfully implemented in Russia, can be called "Remote monitoring of patients with chronic non-communicable diseases", which is a new and unique service for monitoring and correcting the human condition.
For example, the project “Remote monitoring of patients with chronic non-communicable diseases”, that is a brand new and unique service for monitoring and correction of the human condition, shows the effectiveness of such projects, that are being successfully implemented in Russia.
Prevention of Chronical Non-Communicable Diseases (PCND)
In fact, the system, that will reduce mortality by 10%, is under development currently. On the first stage of implementation in 22 regions of the Russian Federation there were carried out the pilot projects on remote monitoring for the patients with arterial hypertension, that gave the positive results, - Manager of the “Prevention of Chronical Non-Communicable Diseases” project (PCND) Matvey Malkin says.
According to the results of conducted projects, such remote monitoring can significantly prevent patients from developing the cardiovascular complication diseases, especially, coronary thrombosis and cerebral thrombosis, and, as a result, to expect halving of the number of hospitalizations and hypertensive crises, reduction of the number of ambulance calls up to 70%. Wide use of such monitoring method will help to save more than 25 thousand lives every year only on the basis of the in-hospital mortality (totally it will save up to 90 thousand lives annually), and may contribute up to 50% in the national rate of decline of mortality from cardiovascular diseases.
In frames of the “roadmap” on improvement of the legislation with participation of the Ministry of Health of the Russian Federation and other regulatory authorities, the organizational and clinical practice in the application of the remote monitoring allowed to draw up the regulatory framework for providing and payment of the telemedicine cervices in the Compulsory Medical Insurance system (CMI) and, as a result, the national healthcare system has got a new segment, that allows all the interested organizations to become participated in.
Currently, the project implementation is successfully being arranged in 30 regions of the Russian Federation. In August 2019, the Ministry of Health of the Russian Federation made a suggestion to the President of the Russian Federation Vladimir Putin to launch a mass implementation of the remote monitoring for patients with the high-risk arterial hypertension from 2020. This measure will enable to conduct continuous monitoring of the health of more than 8 million patients.
In cooperation with the Ministry of Health of the Russian Federation, the HealthNet working group also actively promotes the introduction and development of the new European regulation, that includes the integrated informational and digital registration system of the Eurasian Economic Union. "This system creates harmonized conditions for the circulation of domestic made medicines on the territory of the member-states of the Eurasian Economic Union," - Mikhail Samsonov explained.
These measures have been indicated in the point 21 of the “roadmap” of the HeathNet working group on legislation.
“Harmonization of the conditions also simplifies the registration of Russian medicines in these countries. As a whole, it enables the domestic pharmaceutical companies to enter to the new markets, and, as a perspective, to enter to the global ones. This system also meets the European regulations in general. The measures, taken by the HealthNet working group in cooperation with the Ministry of Health of the Russian Federation, on the documents preparation were aimed on launching and practical implementation of this system on the territories of member-states of the Eurasian Economic Union.”
Case study for further improvement of the regulatory framework
Furthermore, the HealthNet working group on legislation in cooperation with the Ministry of Health of the Russian Federation has drafted a law on the innovational medicines registration that is currently undergoing the necessary approval procedures.
"The introduction of a simplified registration procedure will help to quickly bring innovative, socially significant medicines with a break-through action mechanism to the market. These issues has been discussed since 2015, and now we hope to resolve it,” – Member of the HealthNet working group on legislation Olga Filon said.
According to the law, the medicines can be registered on the basis of a reduces quantity of clinical data, even before the full program of clinical trials will be completed.
“It will change the patients’ quality of live, promote the development of the domestic companies, simplify their entering to the global markets,” – Olga Filon declares.
The innovational pharmaceutical products are used during therapy of oncology, virulent, autoimmune and orphan diseases.
With simplified registration, patients will be able to receive new effective therapies much faster, and the manufacturers take the responsibility to complete the programs of clinical trials and to maintain the pharmaceutical control in order to identify the risks of the medicines use in time. At the same time, the quality control requirements for innovative pharmaceutical products are the same as for the medicines that are registered after a full trials program.However, the registration based on incomplete clinical trials data enables to provide with the therapy those patients, who have exhausted other treatment options, for several years faster.“On the other hand, it allows to the companies to continue their development and to maintain their interest in the break-through researches, the companies can faster bring their products into the market, faster get profit, they will be interested in the innovational products, and do not to produce generic drugs,” – Olga Filon says.