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The adoption by Farmindustria of a Transparency Code was announced in recent days with great emphasis which, starting from next June 30th, will require the publication of the names of doctors who collaborate with pharmaceutical companies as well as data on participation in conferences and emoluments paid for collaborations and consultancy.
All clear and all right. Only that the great epochal innovation concerns, if anything, contracted doctors - as well as university students and freelancers - since the rules on transparency have existed for a long time with regards to medical executives with an employee relationship.
In fact, article 53 of Legislative Decree 165/2001 prescribes that extra-institutional positions must be previously authorized by the Company which «verifies the absence of situations, even potential ones, of conflict of interest». The authorization procedure is governed by paragraphs 7 to 10. It is true that the previous paragraph 6 provides for a series of cases for which authorization is not required and, among them, letters c) and f-bis) respectively identify «participation in conferences and seminars» and «teaching and scientific research» activities.
However, what is obviously not known - and it is hoped that it will not be ignored by the subjects directly involved - is that the following paragraph 11 clearly establishes that "within fifteen days of the payment of the remuneration for the tasks referred to in paragraph 6, the subjects public or private bodies communicate to the administration to which they belong the amount of compensation paid to public employees».
This paragraph was added by article 1, paragraph 42, letter e) of law no. 190 of 6 November 2012, i.e. by the law which dictated provisions on the subject of the prevention of corruption and illegality.
This clarification - and the regulatory context from which it arises - is of no small importance because the Legislator, while recognizing that the activities referred to in paragraph 6 constitute an expression of the free expression of thought protected by article 21 of the Constitution, nevertheless grants the paragraph itself a debt of transparency. It should also be noted that paragraph 13 requires the administrations to which they belong to «notify the Department of Public Administration... of the fees, relating to the previous year, paid by them or whose payment they have been notified by the subjects referred to in paragraph 11» . Therefore, in summary, the activities carried out in favor of pharmaceutical companies are exempt from authorization but not – at least for three years – from the reporting obligation which weighs on private subjects and from the communication obligation which weighs on the company to which they belong.
One last observation. The Transparency Code provides for the prior consent of the doctor and does not provide for sanctions, while the provisions contained in article 53 are obviously an unconditional legal obligation.
The News of the Sole 24Ore – 04/05/2016 [from Federfarma]
Related news: Articles 51-57 Legislative Decree 30/03/2001 n° 165
Article 21 of the Constitution
Efpia Code of Ethics, the challenge between transparency and privacy in the healthcare sector
