In this issue:
- Experts set out main stages for GMP transition
- Amending of the Federal Law “On Pharmaceuticals Circulation” will continue until 2015
- Ministry of Healthcare is developing amendments to the medical goods classification
- Deputies to allow advertising of medical services in non-specialized media
- Requirements to healthcare organisations in respect of clinical trials of medical goods are approved
- The Federal Antimonopoly Service presented the results of a pharmaceuticals pricing survey for Russia, CIS, EU and BRICS
Experts set out main stages for GMP transition
On 18 February, the first meeting was held by the working group responsible for the roadmap for the GMP standards transition for pharmaceutical industry. The document is due to take effect on 1 April 2014.
The Ministry for Industry and Trade will supervise the matters of biopharmaceuticals production in compliance with the new standards, while the Ministry of Healthcare will monitor their use in clinical practice. Accordingly, manufacturers seeking to obtain a certificate for a pharmaceutical will have to obtain opinions from both the Ministry for Industry and Trade (on compliance of the manufacturing conditions to GMP rules), and from the Ministry of Healthcare which will assess the medical effectiveness of the product and the qualifications of the personnel involved in production. The final decision on certifying each product will be made by the Ministry of Industry and Trade.
In addition, Order #87 of the Ministry of Healthcare (dated 28 February 2014) affirms the list of authorized individuals representing manufacturers of medicines for patients treatment.
Amending of the Federal Law “On Pharmaceuticals Circulation” will continue until 2015
According to the Head of the Federal Antimonopoly Service's Department for Control over the Social Sphere and Trade, Timophei Nizhegorodtsev, the process of amending the Federal Law #61-FZ “On Circulation of Pharmaceuticals” will likely continue for another year, and the amendments will not come into force before 1 January 2015.
On 7 February, the latest version of the draft Federal Law “On Amendments to the Federal Law “On Circulation of Pharmaceuticals” and on Amendments to Article 333.32.1. of Part Two of the Tax Code of the Russian Federation” was submitted to the Government. As well as the draft itself, the Cabinet is also working on a table of disagreements between the Ministry of Healthcare and the Federal Antimonopoly Service with regard to the draft.
Ministry of Healthcare is developing amendments to the medical goods classification
An order being drafted by the Ministry of Healthcare, “On amendments to Order #4n of the Ministry of Healthcare of the Russian Federation, “On approval of the nomenclature for classification of medical devices” dated 6 June 2012”, will be discussed between 24 February and 11 March 2014.
The order has been drafted for the following purposes: to develop a uniform government policy on organization and control in the field of healthcare; to form the list of medical goods covered by the standards for equipping a healthcare organization and its structural units in accordance with the regulations on and standards for providing medical assistance; to establish standard costing for providing specialized medical assistance, including high-tech medical aid; to develop long-term government contracts for the supply of medical goods, considering, inter alia, motivation tools for foreign investments into localization of the medical goods production in Russia; maintenance of federal information systems and databases in the field of healthcare.
The document is set to come into force on 1 January 2015.
Deputies to allow advertising of medical services in non-specialized media
On 27 February, the Head of the State Duma's Public Health Committee, Sergei Kalashnikov, submitted a bill proposing amendments to the Federal Law “On Advertising” with regard to advertisements for medical services.
At present, Article 24, Part 8 of the Federal Law “On advertising” prohibits healthcare organizations from mentioning their medical services in general (non-specialized) media publications, which seriously restricts potential consumers’ and patients’ access to information about such services and impairs their awareness and ability to choose the preferred healthcare providers.
To rectify this, the bill proposes amendments to the said restrictive provision, exempting the advertisements for medical services, including preventive, diagnostic and medical rehabilitation techniques. Accordingly, advertising of medical services in the general media would be permitted, subject to compliance with the requirements of Article 24, Part 7 of the Federal Law “On Advertising”.
Requirements to healthcare organizations in respect of clinical trials of medical goods are approved
On 4 February, the Ministry of Justice registered Order #300n of the Ministry of Health, “On approval of the requirements for healthcare organizations performing clinical trials of medical goods and the procedure for establishing compliance by healthcare organizations with these requirements”.
Compliance with the requirements will be assessed by the Federal Service on Surveillance in Healthcare (Roszdravnadzor). The purpose of establishing compliance is to recognize the competence of a healthcare organization in performing clinical trials of medical goods in an appropriate field of medical assistance provided.
Roszdravnadzor will publish a list of healthcare institutions that perform clinical trials on its official website. To perform clinical trials, a healthcare organization will be required to submit a relevant application and a list of the necessary supporting documents to Roszdravnadzor.
The Federal Antimonopoly Service presented the results of a pharmaceuticals pricing survey for Russia, CIS, EU and BRICS
The Federal Antimonopoly Service delivered a press conference by the Head of its Department for Control over the Social Sphere and Trade, Timophei Nizhegorodtsev. The Deputy Head of the Department, Nadezhda Sharavskaya also took part. The speakers discussed the results of a comparative survey of prices for pharmaceuticals and pricing policies in Russia and the countries of the CIS, the European Union and the BRICS group.
The conference covered a wide range of issues: approaches to pricing and medicine compensation in the EU, BRICS and the CIS, price regulations in Russia, comparisons of wholesale prices for expensive medicines and retail prices for the most popular medicines in different countries, problems of drugs availability and the reasons for inflated prices.
The report and the presentation are available at the links: