Table 3. Scope of Disclosure of R&D Payments in Countries With Public Regulation .
Country | France | Portugal | Turkey | Denmark | Slovakia |
Name of regulationa | Law No. 2011-2012 (Law Bertrand) | Decree Law 20/2013 and 128/2013 | Regulation on Promotional Activities of Medicinal Products for Human Use 2015 | Health Act of 2014, Executive Order No. 1153 | Act No. 362/2011 on Medicines and Medical Devices |
Overseeing authority | Ministry of Social Affairs and Health | National Authority of Medicines and Health Products | Ministry of Health | Danish Medicines Agency | National Health Information Center |
Provisions Affecting the Scope of Disclosure Directly | |||||
Categorisation of R&D payments | Disclosed within three major payment categories – advantages (benefits); contracts (agreements); payments related to contracts (remuneration) | Fall within other payment categories, including “subsidies, sponsorships, grants or any other value, good or right granted or received” | No list of disclosed payment categories is provided | One of disclosed “professional affiliations” with industry | Falls under “financial and in-kind benefits” |
Activities associated with R&D payments | Scientific research; consultancy contracts with scientific researchers; contracts regarding scientific expertise; research; clinical study of a biological material | Clinical studies and trials | N/A | Research | Clinical trials, non-intervention clinical studies, post-registration studies of human drug safety, market research |
List of activities associated with R&D payments | Exhaustive | Indicative | N/A | Exhaustive | Exhaustive |
Provisions Affecting the Scope of Disclosure Indirectly | |||||
Funders | Pharma, medical device, in vitro diagnostic medical device, cosmetics, veterinary products, tattoo products, associated providers | Pharma, medical device, other (unspecified) | Pharma | Pharma, medical device, and specialty stores with medical equipment | Pharma |
Recipients | Individual and organisational | Individual and organisational | Individual and organisational | Individual | Individual and organisational (only healthcare providers) |
Exempted payments | Below €10 including taxes | Below €60 | Below 10% of the minimum monthly salary | No | No |
Abbreviations: N/A, not available; R&D, research and development.
aThe dates provided in this row refer to when public regulation of payment disclosure was first introduced. If public regulation of payment disclosure forms part of a larger piece of legislation, we specify, where appropriate, if the regulation of payment disclosure was introduced as a change to already existing legislation. The dates reported here do not cover changes to, or refinements of, legislative provisions focusing on payment disclosure.