Pharmaceutical companies and medical device manufacturers operating internationally need to be aware of increasing transparency and disclosure obligations, breach of which may result in fines or other sanctions.

Background

There is increasing scrutiny on the relationships between health care professionals and organisations and pharmaceutical companies. Following the enactment of the Physician Payments Sunshine Act by the United States, there have been similar measures implemented or discussed across the EU. The European Federation of Pharmaceutical Industries and Associations, which represents the pharmaceutical industry in Europe, adopted a disclosure code in 2013 (the “Code”) that is binding on its members. The Code requires members to document and disclose transfers of value it makes (whether direct or indirect) to or for the benefit of health care professionals/organisations. Of course, many national associations have implemented ethics codes for their members.

The first period for reporting is 2015, with disclosure following the year after.

EU Sunshine countries

France, Portugal and Slovakia have all taken the additional step of implementing ‘Sunshine’ legislation:

  • In France, the legislation obligates pharmaceutical or similar medical companies manufacturing or supplying medical products to disclose agreements made with health care organisations and professionals, including details of incentives offered.
  • In Portugal, the manufacturers or suppliers of such products must keep records of sponsorship of events and be mentioned in the promotional and attendee materials of such events, keep documents available for inspection by the legal authority and notify the national health regulatory authority before any transfers of value.
  • Slovakia requires pharmaceutical companies to submit an annual report to the Ministry of Health regarding the expenses incurred from advertising, marketing and offering discounts or non-cash benefits given to individuals or organisations from the health care industry, together with any beneficiary’s name and address.

Failure to comply with these above acts may all result in a fine, and in France may result in further sanctions against the pharmaceutical company.

Some EU countries have not implemented legislation, but either have existing legislation that imposes similar obligations or further rules or codes of conduct have been introduced. The rules in Belgium and Denmark include reporting on pharmaceutical companies’ business relationships with, and samples given to, health care professionals. Anticipated legislation in Denmark widens the burden to both pharmaceutical and medical device companies, and allowing financial information to become publicly available.

In Germany the burden for transparency is placed almost entirely on the health care professionals although the national association has implemented the Code for their members.

In Italy pharmaceutical companies have a specific disclosure obligation for scientific events where authorisation is required under Legislative Decree No 219 (24 April 2006). There is also an obligation to keep Italy’s Medicines Agency informed of events connected with pharmaceutical products.

In Spain, there are obligations to publicise details of benefits given to health care professionals for conferences, trips and similar events, and funding sources for such conferences must be mentioned. Additionally, the relevant public authority must be notified of materials produced for health care professionals referring to the products. Again, Italy and Spain both have a national implementing Code for their members.

Non-Sunshine countries

The Netherlands, Poland, Sweden and the UK all have national associations with a code of ethics that implement the Code, although in Poland this will not apply until 2016. Swedish anti-corruption legislation may apply and there are industry rules. In the UK, there is an absolute ban on the supply, offer or promise of any gift, financial advantage or benefit in connection with the promotion of medicinal products to health care providers. In addition, the Bribery Act 2010 sets out the general offence of bribery and the specific corporate offence of ‘failure to prevent bribery’.

Conclusion

When building relationships with health care providers across the EU, or raising their company profile, it is important that pharmaceutical companies and medical device providers consider the full fleet of codes, rules and legislation that may apply. Businesses need to be aware that breaches of such measures may result in fines or additional sanctions made against the company and in serious reputational damage.