Transparency in Europe
In April 2015, during the Global Transparency Congress in London, Julie Bonhomme from EFPIA made an assessment on the implementation of its code of practice.
More and more countries are enforcing transparency laws to make the disclosure of transfer of values to HCPs/HCOs mandatory to all pharmaceutical companies:
- Latvia (the legislation is ongoing)
- Estonia: (the law went into effect this year)
- Greece (law dated 24th of December, 2014)
- Romania (2 orders, one in 2015 and one this year)
Among the 33 EFPIA countries, some of them have submitted an application for a deviation to the EFPIA disclosure template such as Denmark, Portugal and France (their deviation was approved in February 2015). The Netherlands and the UK (to manage MEGS) will also have a deviation to the EFPIA template.
Julie Bonhomme also listed specific disclosure rules for some countries:
- In Switzerland, the disclosure platform is multi-stakeholder (like in the Netherlands).
Only transfer of values above 500 € are disclosed.
- In Greece, the disclosure is done on the companies’ and the Association’s websites as well.
- In Portugal, transfers of value will be disclosed 30 days after their delivery. Furthermore, fees are not disclosed.
- In Romania, disclosure is done by the Marketing Authorization Holder, by wholesalers and by distributors. In parallel, a declaration is done to the national authorities.
- In Slovakia, an annual report is done to the Ministry and there is no disclosure for HCPs payments.
And in the rest of the world?
Other presentations have given an interesting insight about disclosure rules outside of Europe:
- In Australia, the disclosure will soon shift from aggregate to nominative. This project is based on a bi-annual pre-transaction disclosure with no aggregate option (if an HCP refuses to give his/her consent, it will not be disclosed).
- In Colombia, there is a draft law dated October 2014 applying to pharma and medical device companies to disclose transfer of values to HCPs, clinics, hospitals other organisations in the healthcare field.
Beside these countries, some other countries are considering the implementation of such disclosure rules:
- In Scotland, in September 2013, there was a petition for a “Sunshine Act for Scotland”.
- In Canada, a movement toward more transparency is driven by an organization called OpenPharma.ca.
- In New Zealand, a similar movement should lead to a legislative approach.
In conclusion, even in the countries where transparency was initially an initiative from professional associations, we can observe that legislation is replacing those auto regulation initiatives in order to solve two issues:
- The risk of consent revocation from HCPs/HCOs
- The lack of enforcement of these rules which applies only to EFPIA members