Clinical trials agreement

Strengthening collaboration for the development of healthcare

SKR and the life science industry have signed two agreements to develop work on clinical trials and quality registers.

In Sweden, there has long been a valuable collaboration between academia, healthcare and industry, and there is now close cooperation. To facilitate and clarify the work, SKR and the life science industry have signed two agreements, one on collaboration in clinical trials and one on quality registers.

The purpose of the agreements is to provide guidance on ethical, legal and financial considerations that need to be made by both principals and companies. The agreement on quality registers also regulates collaboration that goes beyond the legal requirements for data disclosure.

– These agreements clarify how to interact with the life science industry. “Good collaboration is crucial if we are to develop healthcare and provide patients and users with safer diagnoses and better, more evidence-based treatment and care,” says Marie Morell, Chair of the Healthcare Delegation at the Swedish Association of Local Authorities and Regions.

– The life science sector is a knowledge-intensive industry and at the same time a Swedish basic industry of great importance to the Swedish economy. The new agreement will support the work of continuing to develop the increasingly important cooperation between the public sector and the Swedish business community for a world-class Swedish health care system, says Anders Blanck, CEO of LIF, Anna Lefevre Skjöldebrand, CEO of Swedish Medtech, Helena Strigård, CEO of SwedenBIO and Therese Hazelius, CEO of Swedish Labtech.

These agreements replace the previous agreements in these two areas. The agreements are valid until further notice from 1 July 2020. They include collaboration between the publicly funded healthcare system and members of the Swedish Medical Products Industry Association, Swedish Medtech, SwedenBIO and Swedish Labtech.

PDF:Clinical trials agreement
PDF:Agreement on quality registers

Here we interview Eva Löfkvist, BMS and Arvid Söderhäll, Empros Pharmawho have been SwedenBIO’s during the work with the agreement on clinical trials, by Hanna Brodda, Mediefy.

Agreement on clinical trials of medicines and medical devices

What is the objective of the agreement?
The aim is to further build on and strengthen the basis for collaboration that exists in Sweden. between different collaboration partners, with a focus on research and specifically clinical trials in Sweden. Clear expectations and rules for collaboration are important to ensure that we remain at the forefront of high quality and responsible clinical trials. thereby strengthening Sweden as a leading and prosperous life science nation.

Who is behind the agreement?
Sveriges Kommuner och Regioner (SKR), Läkemedelsindustriföreningen (LIF), Swedish Medtech, SwedenBIO and Swedish Labtech.

Who is affected by the agreement?
Among those who have now entered into this agreement are many public and private actors, large and small, who are important for us to have a good climate for clinical trials in Sweden. The parties involved represent not only pharmaceutical companies, but also tech companies, biotech companies, etc. and the Swedish Association of Local Authorities and Regions (SALAR) are an important part of the agreement.

Does everyone have to follow it?
All parties agree that it must be complied with and that we have a shared responsibility to ensure that it is applied.
It is now important that we spread knowledge about the agreement and jointly follow up on the agreement through the joint cooperation group for clinical trials that is being formed.

Why is it important?
The effective development of new treatments, methods and products requires close and trustful collaboration between stakeholders. There is great potential for improved collaboration which the parties want to support with this renewed agreement on clinical trials.
By distinguishing ourselves with responsibility and a good collaborative climate, Sweden can continue to be an attractive country in which to locate company-initiated and company-sponsored clinical trials.

What is the impact on companies?
Through clear conditions and guidance for the relevant contracting parties, the WCC will facilitate the conduct of clinical trials.

What is the difference from the previous agreement developed in 2008?
Since the previous EAC was produced, we have seen a decline in the number of clinical trials in Sweden and the climate of cooperation between healthcare and industry has become more difficult. There are several contributing factors, and while we see that there is still a willingness to conduct company-sponsored clinical trials in Sweden, the possibility for the health care sector to participate has been limited, e.g.. by not giving any time and there is no merit in working on clinical trials. It is a waste of time for younger researchers who want to build a research career.

The parties see that we need to work more together to develop conditions and incentives to stimulate clinical trials in Sweden.

Agreement on collaboration between SKR and industry representatives regarding quality registers.

SwedenBIO has, together with Swedish Labtech, Läkemedelsindustriföreningen and Swedish Medtech, entered into an agreement on common rules for collaboration on regional and national quality registers. The agreement aims to improve the conditions for using quality registers by providing guidance on ethical, legal and financial considerations and creating consistent and transparent forms of collaboration. Compliance with this agreement is a joint responsibility. The parties undertake to disseminate knowledge of the agreement to their respective members and to recommend and actively promote its application by the members concerned. The parties agree to jointly monitor the rules of the agreement through the joint body that will be set up. The agreement applies from July 1, 2020 and until further notice and replaces the previous agreement on collaboration rules regarding National Quality Registers.

PDF: Agreement on quality registers