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From self-regulation principles to a binding legal framework for the disclosure of interactions in the pharmaceutical sector

by Nadezhda Svinarova-Petrova

Today, June 30, 2016, is the last day for innovative pharmaceutical companies to disclose on their websites their interactions with healthcare professionals and health organizations for 2015.

According to preliminary data of Association of Pharmaceutical Manufacturers in Bulgaria (“ARPharm”), the total amount to be disclosed will be of 21 Million Levs and the initiative is well received by healthcare professionals whose prior consent is mandatory for said data publication (http://www.transparencybg.org/index.php?id=332).

In fact, the punch comes from the EFPIA Disclosure Code (European Federation of Pharmaceutical Industries and Associations) adopted in June 2013 on the initiative of the European Commission and the pharmaceutical industry which provides that the first disclosure will happen as from January 2016 and will concern the period of 2015.

To transpose the disclosure requirements on a local level, ARPharm adopted in November 2013 a Disclosure Code on the transfers of value from pharmaceutical companies to healthcare professionals and health organizations (the “Code”).

Its main provisions are, as follows:

  • Introduction of a disclosure principle with respect to the interactions between the pharmaceutical industry, on one hand, and healthcare professionals and health organisation, on the other;
  • Applicable to all members of ARPharm and to companies who have committed to comply with the Code;
  • And when it comes to the following healthcare professionals: doctors, dentists, pharmacists, nurses, midwives, laboratory technicians, medical assistants and pharmacists’ assistants, as well as any person who, within its professional activities is entitled to prescribe, purchase, supply, recommend or administer medicinal products and whose main practice, professional address or place of registration is situated in Europe;
  • In connection with value transfers in cash, kind or otherwise, made for promotional purposes or for the development and sale of medicinal products in human medicine;
  • But only when value transfers concern medicinal products subject to medical prescription;
  • Disclosure shall be made annually not later than 6 months after the end of the reporting period, as each reporting period covers one calendar year;
  • Disclosure of value transfers will be made on an individual basis for each recipient by type of value categories;
  • Disclosure shall be made in Bulgarian on the website of the company, a link to which is published on the specially created general page http://transparencybg.org;
  • Complaints about action or inaction with respect to disclosure principles can be submitted by anyone to the Ethics Commission of ARPharm, which is entitled, in the event of an established breach, to impose monetary sanctions from 2000 BGN to 7000 BGN.

Implementation of said disclosure principles seems as a big step for Bulgaria, through which pharmaceutical companies aim to show that their cooperation with healthcare professionals abides by the highest standards of integrity and is fully in favour of patients.

However, and as provides the Code itself, these are minimum standards applicable on an entirely voluntary basis. They are unfortunately insufficient to achieve the desired objectives.

For comparison, in other countries the requirements go far beyond the field of self-regulation. In countries such as France, for example, self-regulation provisions have already given way to a strict legal framework.

Back in 2011 the French Parliament approved a law by which disclosure of such interactions became mandatory and subject to a fine of €45.000.

Furthermore, the scope of the law is quite wide and continues to expand since it applies to all manufacturers of medicinal products, innovative or generic, and to all medicinal products, regardless of whether they are subject to a prescription or not, whether they are covered by social security funds or not (transparency requirements apply also to cosmetics and drugs in veterinary medicine).

The circle of recipients is also much larger than the Code and includes, for example, students in any of the above medical specialties, editors of radio and television services, as well as newspapers, organizations providing initial and continuing training of health professionals, consulting companies or agencies that operate in the sector of the products concerned, companies developing software for prescription and dispensing of medicines, etc. The disclosures are of two types – disclosure of contracts between the parties and disclosure of distributed advantages.

Whether Bulgaria will follow the French example and will proceed from the field of self-regulation to the adoption of a law with a much wider field of application, is at this stage difficult to predict.

Interestingly enough, there is no unifying European instrument with mandatory application which provides disclosure principles (except EFPIA Disclosure Code, which is voluntary self-regulation).

It would be preferable for the European Union to undertake actions in this direction in order to avoid disclosure discrepancies between different Member States which hampers significantly the application of transparency requirements by international pharmaceutical companies.

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