Legal Update

Legal Update

New Disclosure Obligations under Amended Act on Medicinal Products

On 25 November 2015, an amendment to Act No. 362/2011 Coll. on Medicinal Products and Medical Devices was approved by the Slovak parliament. The amendment will enter into force on 1 January 2016. The law introduces new statutory rules for disclosure of expenditures and direct and indirect transfers of value, inspired by the EFPIA Disclosure Code. The most relevant changes are as follows:

  • The main change is the introduction of a new report on expenses on promotion, marketing, monetary and in-kind contributions provided directly or indirectly to health care professionals (HCPs) and health care organisations (HCOs). It will be a new more detailed form of disclosure for authorisation holders in the pharmaceutical industry and pharmaceutical companies as defined by the law;
  • The Report will be submitted for publication to the National Health Information Centre. The same authority will be also responsible for resolving objections from HCPs and HCOs concerning correctness of disclosed information;
  • The reporting period will be six months (i.e. the Report must be submitted by 31 January and 31 July respectively, first one will be due on 31 July 2016 for the first semester of 2016). The companies with no expenses in the field will also have obligation to report this fact to the authority;
  • The Report will include four basic categories of expenditures in these categories:

- marketing in general,
- promotion of pharmaceuticals,
- in-kind transfers of value provided, directly or indirectly, to HCPs and HCOs,
- monetary transfers of value provided, directly or indirectly, to HCPs and HCOs;

  • The report will include disclosure of transfers of value in the following categories:

- clinical trials,
- non-interventional clinical studies,
- post marketing safety studies of medicinal products,
- market research,
- professional lectures,
- expert consultations,
- participation and registration fees for participation in professional events,
- donations,
- costs of travel, accommodation and meals,
- other purposes;

  • Transfers made in the ordinary course of business relating to sale and distribution of medicinal products will be excluded;
  • In case of indirect transfers of value through a third party, such third party will have a direct statutory obligation to provide the authorization holder or the pharmaceutical company with all the necessary information within thirty days of the transfer of value. This information must be itemized in the same way as the Report;
  • The previously existing but insufficiently applied disclosure duty of HCPs under Section 80 of Act No. 578/2004 Coll. on healthcare providers, health professionals, professional organizations in healthcare and on amendments to Certain Laws, as amended, will be abolished;
  • Sanction mechanism for non-compliance will be changed and sanctions will be increased (EUR 10,000 to EUR 30,000);
  • The amendment poses new challenges to certain aspects of disclosure duties, e.g. differences against the scope of EFPIA Disclosure Code, individual disclosures as compared to disclosures on health care organisations, cross-border aspects. The new legal regulation is however separate from the existing disclosure rules as implemented in the local codes of conduct, changes to those in response to the new regulation are expected shortly.

If you need our assistance in bringing your company into compliance with the amended law, or if you have any other questions, please feel free to contact your contact person in our law firm or Tomas Rybar, partner heading the life sciences practice of the firm.

tel.:+421 2 544 144 41, fax: +421 2 544 345 98