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  • Writer's pictureStoil Petrov

Binding legal framework for the disclosure of interactions in the pharmaceutical sector

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

by Nadejda Svinarova-Petrova and Nikolay Svinarov

Today, June 30, 2016, is the last day for innovative pharmaceutical companies to disclose on their websites their interactions with healthcare professionals and healthcare organizations for 2015. According to preliminary data from the Association of Pharmaceutical Manufacturers in Bulgaria ("ARPharm"), the total amount to be disclosed will be 21 million levs and the initiative is welcomed by healthcare professionals whose prior consent is required. mandatory for said data publication (http: //

In fact, the hallmark comes from the EFPIA Disclosure Code (European Federation of Pharmaceutical Industries and Associations) adopted in June 2013 at the initiative of the European Commission and the pharmaceutical industry which provides that the first disclosure will take place from January. 2016 and will cover the 2015 period.

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

Its main provisions are as follows: Introduction of a principle of disclosure of interactions between the pharmaceutical industry, on the one hand, and healthcare professionals and healthcare organizations, on the other hand;

Applicable to all members of ARPharm and to companies that have undertaken to comply with the Code;

And when it comes to the following health professionals: doctors, dentists, pharmacists, nurses, midwives, laboratory technicians, medical assistants and pharmacy assistants, as well as any person who, in the course of his professional activities is authorized to prescribe, purchase, supply, recommend or administer medicinal products and whose main practice, professional address or place of registration is located in Europe;

In the context of transfers of value in cash, in kind or otherwise, made for promotional purposes or for the development and sale of medicinal products in human medicine;

But only when the value transfers concern medicinal products subject to medical prescription;

Disclosure must be made annually no 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 beneficiary by type of value categories;

Disclosure must be made in Bulgarian on the company's website, a link of which is posted on the specially created general page;

Complaints about any action or inaction regarding the disclosure principles can be submitted by any person to the ARPharm Ethics Commission, which is empowered, in the event of a proven violation, to impose financial penalties of BGN 2,000 to BGN 7,000. BGN.

The implementation of the said disclosure principles appears to be an important step for Bulgaria, through which pharmaceutical companies aim to show that their cooperation with healthcare professionals meets the highest standards of integrity and is fully in favor of healthcare professionals. patients.

However, and as provided for in the Code itself, these are minimum standards applicable on an entirely voluntary basis. Unfortunately, they are insufficient to achieve the desired objectives.

By comparison, in other countries the requirements go far beyond the area of ​​self-regulation. In countries like France, for example, self-regulation provisions have already given way to a strict legal framework.

In 2011, the French Parliament approved a law by which the disclosure of such interactions became mandatory and punishable by a fine of € 45,000.

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

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

It is at this stage difficult to predict whether Bulgaria will follow the French example and move from the field of self-regulation to the adoption of a law with a much broader scope.

Interestingly, there is no unifying European binding instrument that provides disclosure principles (except for the EFPIA Disclosure Code, which is voluntary self-regulation).

It would be preferable for the European Union to take action in this direction in order to avoid the discrepancies in disclosure between the different Member States which considerably hamper the application of transparency requirements by international pharmaceutical companies.

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