New report: Evaluation of the relationship reform
The framework for collaboration between healthcare professionals and companies has just been evaluated. The evaluation concluded that the rules and administration work well, but compliance with the rules lags behind. There is a need for more information to healthcare professionals about the rules.
In 2014, the Danish Parliament adopted new rules for healthcare professionals' collaboration with the industry. The rules were termed the relationship reform, and its aim was to promote openness and transparency of healthcare professionals' collaboration with the pharmaceutical and medical device industries.
The essence of the relationship rules is that collaboration between, on the one hand, companies that manufacture medicines, medical devices and healthcare technology and, on the other hand, doctors, nurses, dentists and proprietary pharmacists must declare those relationships openly on the website of the Danish Medicines Agency.
Certain types of collaboration, for instance unpaid presentations/lectures, are only subject to notification to the Danish Medicines Agency. Other types of collaboration, for instance remunerated work on an advisory board, requires that the healthcare professional applies to the Danish Medicines Agency for approval of the relationship before beginning it. In this process, the Danish Medicines Agency assesses if the collaboration is within the scope allowed by the rules on relationships.
The rules generally work well, but many healthcare professionals fail to notify their relationships
The rules on relationships have been operative for three years and have just been evaluated by a monitoring group with representatives of the following: the Association of Danish Pharmacies, Danish Patients, Danish Regions, the Danish Nurses' Organization, the Danish Nursing Society, the Danish Consumer Council, the Danish Association of the Pharmaceutical Industry, the Danish Medical Association, the Organization of Danish Medical Societies, Medicoindustrien and the Danish Dental Association.
The evaluation concluded that the rules from 2014 and their administration work well. However, the evaluation also pointed out that random checks – crosschecking the healthcare professionals' notifications and the companies' information on who they collaborate with – revealed that more than one third of healthcare professionals had not notified or applied for approval of their collaborations, as they should have done.
"We obviously take this high number very seriously, and together with the monitoring group, we will therefore launch a number of initiatives to increase the number of notifications. We are starting with communication targeting the different professional groups. This is to ensure that lack of knowledge about the rules is not the reason why so many notifications are missing”, says Thomas Senderovitz, Director General of the Danish Medicines Agency. He adds: "Collaboration between companies and healthcare professionals is crucial to the development of our health service and necessary for our research environments to become world-leading. At the same time, it is a main pillar of our health service that healthcare providers are impartial and not influenced by financial interests. It is therefore very important that the rules are followed and that all collaboration is declared."
Following the evaluation, the relationship reform's monitoring group has made a number of recommendations. In addition to the communication initiative which will be implemented in the near future, the recommendations also include:
- Extension of the rules to companies who represent foreign pharmaceutical companies in Denmark.
- A clarification in the legislation that employment with a covered pharmaceutical or medical devices company is subject to prior approval from the Danish Medicines Agency regardless of the kind of duties the healthcare professional will be performing for the company, if the healthcare professional is concurrently undertaking clinical duties somewhere else.
- An obligation for healthcare professionals to also notify participation in international congresses, symposia, conferences and the like held in Denmark. (So far, the rules have only covered events abroad).
The next steps
The report has been sent to the Danish Ministry of Health and the Danish Parliament's Health Committee for further action.
The report in Danish can be read here: Evaluation of the relationship reform (danish only)