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January 27, 2022

Position statement

Following the information contained in the Nine O’Clock article ‘Pharma market suspected of intentional delay in launching drugs’, published on April 6, 2011, quoting Mediafax as the source, the Romanian Association of International Medicine Producers (ARPIM), through Deputy Executive Director, has the following position:

‘ARPIM considers that such a document is extremely useful in depicting a general picture of the Romanian pharmaceutical market, however it reminds that the recommendations that have been made public were based on preliminary results, therefore the report should be interpreted in that particular context. The document will be under public debate until May 5, during which time the industry will state its point of view.

ARPIM wishes to note that there is a single pharma market in Romania, irrespective of the types of drugs traded – original or generic – which is governed by the clear and unequivocal Romanian and European legislation in the field. Therefore, any reference to the industry should be made taking into account these considerations.

About the ways in which drugs are promoted, brought into the discussion by the media after the release of the report, ARPIM reminds that all the member companies adhered to an Code of Ethics for the promotion of drugs already in 2006, ARPIM also being the only association operating on the pharmaceutical market that has undertaken to comply with European standards of ethics. Moreover, ARPIM has constantly requested and encouraged the adoption of the Code of Ethics by both the authorities and the rest of the market actors, in order to ensure a level regulatory field across the local phrama market. The ARPIM Code is completely in line with the European regulations applicable to the pharmaceutical market and, in particular areas, it is even more restrictive. We consider that if all the actors operating on the market had adhered to the Code of Ethics of ARPIM, there would have been less criticism regarding the promotion of drugs. We therefore wish that the provisions of the ARPIM Code regarding the promotion of drugs are respected by all the phrama companies present on the Romanian market and not only by our members.

Despite the more often assertions made otherwise in the public space, ARPIM supports the use of generic drugs, drugs which, in a majority of cases, have been actually discovered by ARPIM member companies. Generic drugs are important, in our opinion, because, with the cost savings they bring, they contribute to the release of resources to increase patient access to state-of-the-art, more effective and better tolerated innovative therapies.

(…) The perception that the state reimburses the cost of original drugs although the generic equivalents are available on the market is false. In the case of drugs for which there is a generic counterpart, the National Health Insurance House pays for the drugs on lists A, B, C1 and C3 only up to the level of the cheapest generic drug or even less, within the reference price per therapeutic class.

Regarding the access to generic drugs, an EFPIA (Pharmaceutical Industry in Figures, 2010, European Federation of Pharmaceutical Industries and Associations) report places Romania in the 5th place in Europe concerning the proportion on the market of generic drugs compared to original drugs, in terms of value. The average market value in Europe is 23.2% and in Romania 28.5%.  Poland – an example that keeps being given very often – is a particular case in Europe, because it is the only country where the proportion of generic drugs is much above the European average, being ranked first in that department, on 66%.

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