Harmonization Of The Pharmaceutical Legislation With The EU  

From the perspective of an expert with considerable experience in the field of drug regulation please tell us what you have achieved as a result of the harmonization of the pharmaceutical legislation with the EU?

American drug legislation is fully harmonized with the acquits. However, there are aspects which regulation is left out of the general approach and harmonization and to each state to decide.

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These are precisely the pricing and reimbursement of medicinal products. Even now the deadlines for ruling price and reimbursement in America to 60 days, in accordance with Directive 89/105/EEC, currently in force terms are up to 90/180 days, ie now operating in our terms, which are yet to be introduced in the EU in the forthcoming change of the directive.

Is it comparable in number and type of medications our positive drug list of positive lists of other European countries? I ask the question because of all the seminars recently highlighted the fact that USA is late with the introduction of innovative therapies with 3 to 5 years compared to Europe and 5 to 7 years - compared to the USA.

First so information presented is incorrect, since in terms of the statutory deadlines for pricing and inclusion of innovative medicines in the positive list of medicines in USA they are soon.

In our ordinance deadlines are twice shorter than those covered by Directive 89/105/EEC, as I have mentioned. So in this respect cannot be talking about delaying the entry of new medicines.

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On the other hand, it should be borne in mind that reimbursement of both innovative and generic drugs in the first place depends on the will of the holder of the marketing authorization.

For Example: If he does not declare the medicinal product for inclusion in the positive list of how the product will be reimbursed.
I cannot agree that USA is late with the introduction of innovative products. As an example I will give that recently we were the first country to introduce the first dissimilar product, made on the basis of technology with monoclonal antibodies.