Общероссийская общественная организация инвалидов-больных рассеянным склерозом

Federal Service for Health Control: Medicines in the Programme “Seven Nosologies” are provided regardless of patients’ having disabilities and keeping rights for benefits

September 12, 2008

Some time ago, we told our readers of the paradox with regard to providing Russian PwMS with drugs which modulate the course of their disease. On the one hand, the medical profession claims PwMS start modulating treatment as soon as possible, i.e. shortly after their diagnosis, but on the other hand, Russian PwMS were able to start the therapy no sooner than their first disabilities came up and were confirmed. Thus, the preventive power of the drugs, which is especially valuable in MS, was formally cut off.

However, this has been eliminated. This year, PwMS and those suffering from the other six nosologies, identified as severe and rare and highly expensive for management, can receive an adequate treatment right away after they are diagnosed without awaiting their disabilities development.

To get rid of any ambiguity in this vital issue, Elena Telnova, Deputy Head of the Federal Service for Health Control in the RF (ROSZDRAVNADZOR) explained the procedure of provision of pharmaceuticals in the Programme of providing patients with rare chronic diseases (“Seven Nosologies”) with high-priced medicines. The explication was given in reply to the request of the All-Russian Society of people with hemophilia.

In particular, the letter reads: “According to Article 56.2 of the Federal Law #238-FZ of December 19, 2006, purchases of pharmaceuticals to treat hemophilia, mucoviscidosis, pituitary nanism, Gaucher's disease, myeloleukemia, multiple sclerosis, as well as conditions after organ/tissue transplantations are carried out in accordance with the data in the Federal registers for patients with the above-mentioned nosologies.

Centrally purchased pharmaceuticals shall be provided to patients regardless of whether they have their disabilities formally confirmed, as well as to patients who have refused the state social assistance in the form of social services for 2008… Therefore, centrally purchased pharmaceuticals may be released to patients included in the Federal registers on the mentioned nosologies regardless of whether they keep their right to get the state social assistance in 2008.” (Translator’s note: before, all medicines, those for MS included, were released to patients for free only on the condition of their keeping this right to get the state social assistance, which reduced their disability benefits)

(AMI-TASS)

MS Day in Regions of Russia

Regional branches of the All-Russian MS Society held the action ’11 June – Multiple Sclerosis Day’. The key goal of the action was to raise awareness about MS in their communities as well as to provide PwMS with emotional and, sometimes, material support.

Thus, volunteers, students and members of the Society branches held the action in the cities of Krasnodar, Stavropol, Rostov, and Volgograd of the South Federal District. They would spread bands with information about MS on them in busy parts, especially near, and in, health centres. In the Kalmyk Republic, members of a religious society made up packages with grocery products and distributed them throughout the republic.

Members of the Barnaul regional branch of the Society approached sponsors to make 500 copies of the leaflet with brief information about MS, its tendencies and consequences, which they mailed to organizations and enterprises with a direct-mail service. In Ulyanovsk, they held Round Tables and meetings within the frames of the action. One of the topics for discussion was ‘Social partnership. Human health as the concern of the state and NGO’. This function was held at the Oblast Legislative Assembly. Also, the Department of Social Protection of the Population held another Round Table with the participation of President of the All-Russian MS Society Yan Vlasov. On the streets of Ulyanovsk, volunteers managed to hand out 100 white bands within the frames of the action, meanwhile 200 such bands were handed out in the city of Omsk.

One of the most popular TV channels in the Kirov oblast told about the All-Russian MS Society as well as about its branch working in the Kirov oblast. The TV channel broadcasted once again the information that there are pharmaceuticals to help PwMS live an active life.

In the Chuvash Republic, they gave emphasis to drawing the community’s attention to MS through posting informational leaflets. Besides, the volunteering participants of the action could answer questions of passers-by. On summing up the event, they offered to hold such an action again in future.

One of the ‘MS Day’ functions held in Samara on June 11 was the Creative Competition-Festival of the Disabled ‘We Stand Together’ organized by the Ministry of Health and Social Development. The festival was a demonstrative example of how people with disabilities can socially adapt, raising the tolerance in society towards disabled persons, and bringing various structures to solve disability problems.

Quite a few regional branches implemented the action for the first time. However, many people in Russia were able to get to know or learn more about MS on this day, while the MS Society branches proper had the action as their first and important experience of this kind of work.

Tatiana Golikova: The Ministry of Health and Social Development is working on the ‘National Pharmaceutical Policy’ project to be implemented no sooner than 2010

11 June, 2008

Galina Baryshnikova

“Such a document, which contains the principles of pharmaceutical insurance, is available in any self-respecting nation, so we need not develop anything new here in Russia. However, our nation has got its own difficulties, and it is important to have such an insurance scheme, which will work,” said Tatiana Golikova, Minister of Health and Social Development, on June 11, to reporters at the meeting in expectation of the Medical Profession Day celebrations. According to the Minister, the development of the ‘National Pharmaceutical Policy’ paper is in progress concurrently with the legislative package of regulatory enactments that are related to the modernization of the General Medical Insurance (GMI) entire system. “By the end of this year, the document on the GMI modernization should be developed, and the scheme proper of the GMI functioning is planned to launch in 2010.” Tatiana Golikova informed.

“Today’s situation is paradoxical – people’s health, their therapy with pharmaceuticals depend on how many people leave or stay in the Additional Pharmaceutical Support programme (Note: Russian disabled pensioners may choose the APS to enjoy all necessary for them medicines for free; instead, they may get a fixed amount of roughly €20 added to their monthly benefits), on whether the allocated money covers all beneficiaries and whether the pharmaceuticals purchase auction takes place,” the Minister emphasized. “The system is somewhat strange, isn’t it?” said the Head of the Ministry.

In the first place, the pharmaceutical insurance will cover those enlisted in the register of people qualifying for entitlements in the APS programme. Later on, the other disadvantaged groups of people will be entitled to the pharmaceutical benefits. The insurance principle in question means there will be one counter in each drug-store instead of two now, where one stall serves the customers with benefit recipes, while the other sells wholesale medicines at business prices. “We’ll abandon this kind of system. A patient, who has a GMI certificate (no other policy required), will come to a drug-store and get a medicine for free or at full cost that is to be reimbursed by the state,” Tatiana Golikova made it clear. The Minister believes that the switching onto the new GMI system must not get people panicking as it happens when innovations are introduced. “I don’t think this will be any painful for our society: Much depends on how the system is set up. The main challenge is to avoid disturbances and revolutions,’ The Minister noted.

 (www.pharmvestnik.ru)

Amendments to the law ‘About Pharmaceuticals’ to promote the introduction of the latest innovative developments to the market

9 July, 2008

Galina Baryshnikova

(FEDERAL NEWS) The Ministry of Health and Social Development and the Ministry of Industry and Trade are developing a draft law “About Making Amendments in Federal Law 89 ‘About Pharmaceuticals’”, which is to take into account interests and priorities of the national pharmaceutical industry. This was the point that Andrei Gaiderov, the Deputy Head of the Department for pharmaceutical operations in the regional and informational policy in Health and Social Development of the Ministry of Health and Social Development of the Russian Federation, made at the Round Table meeting ‘How to make pharmaceutical industry achievements available for Russian people’; the meeting took place in the Federation Council on 8 July. ‘Application of the provisions of this draft law must bolster the development of the Russian national pharmaceutical industry and decrease the time period needed for the latest innovation technologies to enter the market,’ said an officer of the Ministry of Health and Social Development. He was hopeful that the State Duma and Federation Council would support the draft law ‘About Pharmaceuticals’.

The draft law provides for the perfection of the scheme, which permits pharmaceuticals to enter Russia, for the increase in the responsibility of all parties dealing with pharmaceuticals for, in the first place, the efficacy and security of pharmaceuticals, said Andrei Gaiderov. It is planned to make amendments in the legislation in effect with regards to regulating the requirements for the management of production and quality control of pharmaceuticals.

In particular, the draft law promises to streamline the licensing of pharmaceutical production through reducing administrative barriers with ensuring that the state keeps controlling the execution of all license requirements and conditions. All manufacturers working in the Russian market will be inspected.

The draft law allows for producers to release medicines into circulation on the basis of confirming production terms and controlling that the quality of each series meets specified requirements, which will make it possible to increase the responsibility of the parties dealing with pharmaceuticals. Its provisions regulate the scheme of permitting pharmaceuticals to treat rare diseases, and they abolish the registration of pharmaceutical substances, Andrei Gaiderov told. He reminded that the state control for the quality of substances is maintained and there is nobody to cancel it.

The draft law is supposed to have the registration period altered according to that adopted in the EU; the list of data is specified that are established for applicants to submit when registering; the state examination rules as well as those for the registration of pharmaceuticals are established there. As the draft law regulates, the procedure of registering reproduced pharmaceuticals is significantly alleviated, and this will allow to provide the market more efficiently with pharmaceuticals of high demand.

The new law deals a lot with securing intellectual property, which the applicant submits when registering and examining pharmaceuticals, in particular those generated at clinical and pre-clinical studies. This law provision is to secure both the copyrights of developers of innovative medicines and the fastest introduction of them into the healthcare practice, a representative of the Ministry of Health and Social Development emphasized. The law makes a provision for measures to fight the circulation of pharmaceuticals of poor quality, for perfecting the state regulation as far as import and export of pharmaceuticals in the retail business are concerned.

www.canonpharma.ru