New Methodology for the Calculation of the Maximum Prices of Medicinal Products
According to a press release, during the Government’s session from September 28th, 2016, an Emergency Government Ordinance was adopted for the modification of Article 890 of Law 95/2006 on the reform of the healthcare system (Law 95/2006), according to which the new methodology on the calculation system and approval procedure of the maximum prices of medicinal products for human use authorized for being placed on the Romanian market will be approved by Government Decision, pursuant to the proposal of the Ministry of Health.
As you probably already know, the methodology for the calculation of the maximum prices of medicinal products is currently regulated by Order of the ministry of health no. 75/2009.
The emergency government ordinance modifying Article 890 of Law 95/2006 will enter into force at the date when such will be published in the Romanian Official Gazette, except for the case when the normative text stipulates a different date for its entrance into force.
According to the press release, (probably) in the near future, a new methodology on the calculation system and approval procedure of the maximum prices of medicinal products will be adopted. Therefore, we expect that the project of the Government Decision will be soon published on the Government’s official website.
As far as Article 8 paragraph (1) of Order 75/2009 is concerned, according to the press release, despite the fact that any price reduction of medicinal products is applauded, as a principle, the side effects of such measure over the access to medicinal products must be considered. According to the analysis of the independent experts of the World Bank and of the representatives of one of the most important public health institutions, London School of Economics, this measure will lead to the disappearance from the Romanian market of some essential medicinal products, while such measure will have no impact on the budget of the National Health Insurance House as such reimburses the price of medicinal products in accordance to the price of the generic medicinal products and not in accordance to the price of the off-patent medicinal product.
The entire press release can be accessed here.