Success Story: Regulation on Ethical Drug Promotion

Success Story: Regulation on Ethical Drug Promotion

• 04.10.2018

What is it about?

On October 3, the Government approved the Regulation on ethical drug promotion to healthcare professionals and consumers.

What does it do?

The Regulation provides clear rules on the interaction between healthcare professionals and pharmaceutical businesses.

The aim is to prevent unethical and illegal understandings by regulating:

(i) prohibition on gifts and any monetary compensation for the prescription of drugs of a certain brand;
(ii) mandatory declaration of sponsorship expenses by pharma companies;
(iii) obligations of medical sales representatives and rules concerning their visits;
(iv) limits and rules on hospitality at events organized by companies;
(v) rules on the content of promotion documentation.

The text of the Regulation is harmonized with the EU Directive 2001/83/CE and seeks to implement best international practices.

How was AmCham involved?

AmCham Healthcare Committee was instrumental in the adoption of this regulation at all stages of the process. Back in 2016, as a result of a study commissioned by AmCham, an initial draft of the regulation has been prepared and submitted to authorities. Since then, AmCham has continued advocating for this initiative through a series of negotiations, position papers and correspondence that have reshaped the document leading to its final approval.

What’s next?

Proper implementation will be crucial in making sure that all market players are held by same ethical standards and consumer rights are protected.