Update: The Danish HCP Affiliation/Sunshine Act

On 20 May 2014 the Danish Parliament passed an act, which will transform how pharmaceutical and medical device companies may interact with Danish healthcare professionals. Furthermore, the act - which enters into force on 1 November 2014 - provides for a much higher degree of transparency. Pharmaceutical and medical device companies conducting  business in Denmark must prepare themselves for a novel regulatory landscape.

The Danish HCP Sunshine Act is comprised by two separate regimes and principles, covering

  • companies' affiliation with HCPs; and
  • companies' provision of economic benefits to HCPs.

Affiliation

Under the existing Danish regulations, medical doctors, dentists and pharmacists must obtain a prior permit from the Danish Health and Medicines Authority to have a professional and/or economic affiliation with a pharmaceutical company. 

The Danish HCP Sunshine Act will expand the scope of application of the existing regulations on two points:

  • Affiliation with medical device companies is included; and
  • Nurses are included (but only in relation to affiliation with medical device companies).

Furthermore, the permission regime is abolished for certain forms of professional and economic affiliation if the affiliation is considered to be useful from a professional point of view and with only a slight risk of affecting the HCP's impartiality (examples are "lecturing" and "research"). Instead, the HCP is "merely" to report the cooperation to the Danish Health and Medicines Authority. However, a permission regime will apply to pharmaceutical and medical device industry affiliation which is characterised by "advisory" services, e.g. participation in advisory boards. 

It is important to note that it is the duty of the HCP to either apply for the Authority's permission or to notify the Authority. 

The companies' duties are:

  • to inform the HCPs of the HCPs' duty to either apply for the Danish Health and Medicines Authority's prior permission or to notify the Authority. Companies that do not observe this requirement may be subject to fines;
  • to forward an annual report to the Danish Health and Medicines Authority comprising details about any and all HCPs, who have been affiliated with the company within the preceding calendar year.

On the basis of the HCP's application/notification, the Danish Health and Medicines Authority will disclose information available to the general public, including competitors, containing the following information:

  • the name/identity of the HCP;
  • the name/identity of the company;
  • a description of the affiliation and its duration; and
  • the combined value of all remuneration paid by the company to the HCP during a calendar year.

As a finishing remark, it is worth noting that the Danish HCP Sunshine Act will introduce an application scheme for HCPs' future acquisitions of shares/stocks (or other types of ownership) in companies marketing pharmaceutical products or medical devices. However, HCPs may acquire shares of a value not exceeding DKK 200,000 (~ EUR 26,850) from each company, given that the Danish Health and Medicines Authority is notified of the ownership. The Danish Health and Medicines Authority will make information of such stockholdings public.

Economic benefits

It is important to note that, in relation to economic benefits, the term HCP is not limited to doctors, dentists, nurses and pharmacists but covers a much wider range of professionals, including (but not limited to) radiographs, midwives and senior employees in retail shops selling medical devices. 

The Danish HCP Sunshine Act will not make material amendments to the executive order currently applicable to pharmaceutical companies, apart from abolishing the provision of courtesy gifts to HCPs and abolishing the use of competitions/raffles when promoting pharmaceutical products towards HCPs.

Instead, the major change is that medical device companies will be subject to the same requirements as pharmaceutical companies. It follows that medical device companies may no longer provide economic benefits to HCPs, save for the explicit derogations which will be provided. These derogations will be set out in an executive order. The executive order has not yet been passed, but a draft has just been published for public consultation.

According to the drafts, derogations will be made for e.g. providing modest gifts (but not courtesy gifts) to HCPs as well as providing travel and accommodation (in relation to HCPs' participation in events of a professional nature). However, and notably, a similar derogation for lending equipment to HCPs will not be included and it is thus likely that medical device companies will need to rethink their business models.

HCPs receiving sponsorships from pharmaceutical and medical device companies for participation in events outside of Denmark must notify the Danish Health and Medicines Authority of the sponsorship. The Danish Health and Medicines Authority will then make the information public.

The companies' duties are:

  • not to provide unlawful economic benefits to HCPs; and
  • to inform the HCPs of the HCPs' duty to notify the Authority of sponsorships relating to events taking place outside of Denmark. Companies failing to observe this requirement may be subject to fines.
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