The main point about rare medicinal drugs
is their effectiveness

26
NGOs have sent  a ‘shopping list’ to the
ministry of health of the Russian Federation (RF) containing amendments that
they propose should be made to the Distribution of Medicinal Preparations Law
and also sent a submission to Vladimir Putin and Dmitry Medvedev regarding the
drafting of the Federal Contracting Arrangements Bill.

On
11 March NGO representatives spoke about the amendments that they had prepared
at a press conference held at RIA Novosti. According to Yuri Zhulev, the
president of the National Haemophilia Society, the legislative database of
bioanalogous and rare drugs in Russia is underdeveloped. The procedure for
registering them and investigating them is similar to that applicable to other
drugs. He said. however, that as there are very few patients suffering from
rare diseases in Russia, it is practically impossible to assemble the required
number of patients for the purpose of conducting clinical trials. So he
proposed that the results of research undertaken in other countries be studied.
He also suggested that the period for examination and trial required
before  the drugs might be imported into
the RF be shortened to the minimum possible. He stated that the certification
process for rare drugs was too drawn out. This hampered the process of
supplying patients suffering from rare diseases with the necessary medication.

Mr  Zhulev expressed the belief that price is
the main criterion for purchasing drugs under the Supply of Goods, Execution of
Works and Provision of Services for State and Municipal Needs Federal Law. Even
drugs sold under the same international non-patented  name (INN) might differ substantially as regards both quality and
price. ‘Patients might need drugs with different brand names even though they
are sold under the same INN’, he explained. He went on to say that questions of
price should not be decided at the expense of effectiveness and quality. If a
preparation does not produce the required effect, then the condition of the
patient will worsen and more expensive treatment will have to be found.
Furthermore, it is essential to provide for a mechanism for making special
purchases of drugs and equipment where indicated for medical reasons regardless
of cost.

The
president of the multiple sclerosis association, Yan Vlasov, raised the issue
of the substitutability of drugs. He thought that  clinical research ought to be undertaken in order to determine
the degree to which drugs might be substitutable. It would be possible to
characterise them as being such only when their total pharmacological,
biological and therapeutic equivalence had been proven. In his turn, the chair
of Delovaya Rossia’s* health board, Dr David Melik-Guessing, identified another
set of issues. The first concerned the Principles of Safeguarding the Health of
Citizens of the RF Federal Law. Under Article 16, it is the subjects of the RF
that carry responsibility for the treatment of rare and socially significant
diseases like TB and HIV. But in so far as the majority of the regions are
grant aided, there was a worry that significant discrepancies could arise. The
second problem, according to him, related to the distributors  of medicines. Currently there are estimated
to be some 1,500 of these. Dr Melik-Guessing suggested that the majority of
companies receiving support from the regional authorities were not up to the
job. He proposed importing additional criteria into the legislation governing
the selection of companies that are allowed 
to become distributors.

*
Business Russia – Union of entrepreneurs of the non-commodity sectors of the
economy.

http://www.asi.org.ru/ASI3%5Crws_asi.nsf/va_WebPages/8DE8744AA23968B0442579BE003D6034Rus