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Medical devices – new self-regulation (Finland)

, Castrén & Snellman, Finland Hilma-Karoliina Markkanen, Castrén & Snellman, Finland

The importance of self-regulation in medical technology industry increases as the new Finnish Ethical Code includes monetary sanctions

MedTech Europe, the European trade association representing the medical technology industries, approved its new Code of Ethical Business Practice in December 2015 (MedTech Europe Code) setting high ethical standards for European medical technology industry. The new MedTech Europe Code made a difference to the then current situation by introducing a new ethical code binding on its members, as the previous guidelines were only non-binding. The new MedTech Europe Code became binding for MedTech Europe's corporate members on 1st January 2017.

Sailab – MedTech Finland ry (Sailab), a registered association of health technology suppliers founded in 1977, is the Finnish national organization of the health technology companies with over 100 members. Due to the new MedTech Europe Code, Sailab introduced its own national Code of Ethical Business Practise (Sailab Code) in December 2017, which is based on the MedTech Europe Code. The Sailab Code is binding on Sailab and its member companies, but their liability can extend also to acts or omissions of a third party when a member company cooperates with such a third party.

Regulatory regime of medical devices and health technology in Finland and the increasing importance of self-regulation

The Finnish Medical Devices Act (629/2010) and orders issued by the National Supervisory Authority for Welfare and Health, govern medical devices and their marketing in Finland. The Medical Device Act defines a medical device as any instrument, apparatus, appliance, software, material or other article intended by the manufacturer to be used for human beings for the purpose of, inter alia, diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or handicap.2 Regulations EU/2017/745 and EU/2017/746 govern or will govern medical devices sector also in Finland after the transitional periods.

Self-regulation has traditionally played a key role in the pharmaceutical sector in Finland. Previously, Pharma Industry Finland (PIF), an organisation of the innovative pharmaceutical industry, has issued a Code of Ethics (PIF Code) containing very detailed provisions that are binding on its members. The PIF Code is based on medicines, competition and consumer legislation and on the marketing guidelines of the equivalent European and international federations, most importantly the European Federation of Pharmaceutical Industries and Associations (Efpia).

After Sailab issued its own new Sailab Code based on the MedTech Europe Code, the impact and importance of self-regulation in the field of medical devices and health technology is likely to increase in Finland. The new Sailab Code will bring health technology industry closer to the pharmaceutical industry in a sense that the self-regulation will play a key role in both sectors after the new Sailab Code.

More precise framework for indirect sponsorship and gifts

The updated Sailab Code became effective on 1st January 2018 with a transition period, which will end on 1st January 2019.

The Sailab Code aims to enable development of health technology industry, ensure safe and impressive use of health technology and contribute to development health care professionals' (HCPs) clinical expertise, patient safety, and improving and developing new health technology solutions and related services. The Sailab Code is a minimum requirement for Sailab's member companies. Additionally, Finnish legislation, regulations, rules or professional guidance, including corporate instructions, are naturally applicable.

The new MedTech Europe Code and Sailab Code present reforms such as generally agreed definitions, phasing out of direct sponsorship, transparency of educational grants and more stringent framework, general criteria for all events and product and sample demonstrations.

From 1st January 2018, economic or otherwise deemed aid granted directly or individually to HCPs for education or training organized by a third party, must be discontinued. Further, every organized event must be useful to HCP's knowledge and expertise. The Sailab Code also provides for detailed criteria for organizing such events and training, such as their location, duration and HCP's accommodation. For example, cruises, golf clubs or spa facilities are not suitable and acceptable places for education or training events organized by Sailab's member company. Acceptable places include, e.g. hospitals, clinics, surgical centres or laboratories, or training/conference centres of the like, including member company's own spaces that may be considered necessary and corresponding to the objectives of the training.

In general, the promotional gifts given to HCPs must be low of value, i.e. the promotional gifts must have only minor economic significance for the recipient. Provision of educational products and/or gifts cannot reward, attract or encourage HCPs or social and healthcare organizations to buy, rent, to recommend, to order, to use, offer or acquire member companies' products.

The Sailab Code does not address the marketing of medical devices in general. The marketing rules for medical devices are largely the same as general Finnish marketing legislation, orders and principles, such as the Finnish Consumer Protection Act and the Regulation on unfair practices in marketing and customer relations. The marketing of medical devices is therefore generally allowed, but all marketing activities must be objective and give a truthful and reliable description of the product. The Act on Medical Devices contains a specific provision on marketing. Marketing of medical devices may not be inappropriate and it may not give an exaggerated or erroneous impression of the device, its effect or use. The marketing of medical devices includes all possible direct or indirect actions that have the purpose of promoting the product and influencing the product's sales.

Sanctions will be applicable from 2019 to members not complying with the Sailab Code

According to the Sailab Code, Sailab establishes an ethical monitoring committee in 2018 and the committee will commence its operations after the transition period 1st January 2019. The ethical monitoring committee will monitor and control the observance of the Sailab Code and handles complaints related to the Sailab code or its application and procedures. The ethical monitoring committee shall also have the power to decide on possible sanctions resulting from breaching the Sailab Code.

A non-compliance complaint must be submitted to the ethical monitoring committee within a year from the alleged breach, after which the committee will handle the complaint within 90 days. In case the complaint is processed, a reconciliation process is initiated as a first step, and if no reconciliation is achieved, the committee will give its decision in a matter after hearing the parties. Each party to the complaint may ask the MedTech Europe for a decision regarding the interpretation of MedTech Europe Code, to which the Sailab Code is base on, within 15 days. The national decision is enforced only after the MedTech Europe has issued its instructions regarding the interpretation of MedTech Europe Code for the final decision.

Sailab's general meeting approves each year sanctions for the next calendar year and the ethical monitoring committee is entitled to impose such sanctions according to its discretion. The imposed sanctions must be proportionate, foreseeable and preventive. Proportionate to seriousness of the breach, the ethical monitoring committee can impose, e.g. a written notice, fines as well as control and audit obligation.

Importance of new Sailab Code to health technology businesses

To summarize, the importance of self-regulation is likely to increase also in medical technology industry due to more detailed codes of ethical business practice of MedTech Europe and Sailab. The fact that the Sailab Code provides for actual monetary sanctions stresses the importance of observing the Sailab Code closely in the future.

  1. Hanna Paloheimo is a counsel and Hilma-Karoliina Markkanen is an associate at Castrén & Snellman Attorneys Ltd.
  2. Medical device means also any such product intended for the purpose of investigation, replacement or modification of the anatomy or of a physiological process or control of conception.