ОБЩЕРОССИЙСКАЯ ОБЩЕСТВЕННАЯ ОРГАНИЗАЦИЯ ИНВАЛИДОВ-БОЛЬНЫХ РАССЕЯННЫМ СКЛЕРОЗОМ

RUSSIAN PHARMACEUTICAL MARKET GAINS STRATEGIC IMPORTANCE FOR OVERSEAS BUSINESSES

27.03.2008

According to the aggregate results of the STADA Group, overall sales in 2007 reached €1.57 billion, which beats the results in 2006 by 26 percent; €990.7 million out of the figure (63 percent) fell on international sales (sales beyond Germany). The dynamics growth figure for international sales of the STADA Group’s produce rose by 30 percent as compared to 2006.

According to volume of proceeds, the STADA Group rates the Russian pharmaceutical market as the 2nd amongst all those abroad, where the STADA is represented.

David Melik-Gusseynov, Director of the Market Research Centre ‘Pharmexpert’, observes on the results:

Today, the STADA is among the first overseas pharmaceutical companies having their stake on the long-term development of the Russian pharmaceutical market. In this context, the STADA’s dynamics of sales growth for Russia is self-explanatory: the company’s sales volume, which operated in the Russian market independently, reached €0.7 million in 2004; after acquiring the ‘Nizhpharm’ company, the STADA grew to be €56.6 million worth in 2005. The figure of sales volume in the Russian market for 2007 was estimated €133.8 million (as compared to €87.5 million in 2006); the increase by 53 percent was also ensured by finishing the purchase of the Makiz-Pharma company.

In point of fact, the purchase of the ‘Nizhpharm’ company in 2005 introduced a new stage in the Russian market development and its integration into the world pharmaceutical market. Now, the STADA is represented in Russia in both the business sector and that of Additional Pharmacological Support (Note: this is to enlist persons with conditions requiring expensive treatment). The Holding was the 11th in the business segment of the market in 2007.

Besides, the STADA has already managed four production sites: Nizhpharm (Nizhny Novgorod), Makiz-Pharma (Moscow), Skopinpharma (Ryazan oblast), Khemopharm (Obninsk). In 2007, the Holding was the 3rd largest among Russian pharmaceutical producers according to volumes of their output covering an 8.1 percent segment (excluding the products of Khemopharm, which did not take part in the rating), giving way to the Pharmstandart and Otechestvennye (Domestic) Drugs companies.

Meanwhile, other companies may follow the STADA’s example very soon. Thus, for instance, the Gedeon Richter Company currently owns two production sites in Russia; one of these was built independently by the Company and has been in operation since 2001, while the second site was the Akrikhin Venture, which the Company acquired as a result of merging the Polpharma company.

Rapid development of the Russian pharmaceutical market, in particular, of the business sector, makes it very attractive for overseas businesses making opportunities for developing the relatively free operating space.

Market Research Centre ‘Pharmexpert’ Press Service

OBLAST ANNUAL ACTION “CHARITY ANGEL”

5 June, 2008

(REGIONAL NEWS – SAMARA OBLAST GOVERNMENT) The Health and Social Development Ministry have pooled the results of the annual action “Charity Angel - 2008”, which was dedicated to the Social Worker Day. There were 33 province districts participating in the action. In all, the action was initiated for the 6th time. Incidentally, participants of the action grow increasingly in number annually. Say, this year there have been 93 applicants, while there were 89 last year.

Samara Oblast Acting Governor Alexandr Nefedov and Health and Social Development Minister Vadim Kulichenkov awarded a diploma of honor and a rich reward to Svetlana Goronkova, Samara Public MS Organization Executive Director, in the “Against the Fate” nomination. This excellent appreciation of the organization’s activities is a true bottom line to the amount of work Svetlana has performed over the one and a half year period that she has headed the organization.

The Acting Governor expressed his sincere thanks and said: “I believe your activities will keep on being highly distinguished for outstanding professionalism, competence, delicacy and hearty generosity.”

(ms.samaradom.ru)

CREATIVE COMPETITION-FESTIVAL “WE STAND TOGETHER”: SAMARA MS SOCIETY’S A PRIZE-WINNER

11 June, 2008

(REGIONAL NEWS)

Together With Stars!

District Officers’ House –  An Oblast Creativity Competition-Festival of the Disabled “We Stand Together” took place on 11 June, 2008 that was held by the Samara Ministry of Health and Social Development. This was associated with festivities of the Social Service’s 90th anniversary.

Participants competed in four nominations being singing, instrumental execution, choreography, and recitation. In accordance with performance results, the jury qualified the winners, who made it to participate in the project “Together With Stars”. Lyudmila Avdoshina represented the MS Society and became a prize-winner.

The festival, as event, is to encourage people with disabilities to come to doing various arts in order to ensure their social adaptation, finding out more abilities, raising the society tolerance towards disabled people, drawing statutory, public and business structures to solve disability problems.

(ms.samaradom.ru)

Amendments to the law ‘About Pharmaceuticals’

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

‘National Pharmaceutical Policy’ Development

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)