New winds in the healthtech regulatory sector

As the year 2021 is drawing to a close and the new year is just around the corner, it is time to take a look at what the ongoing year has brought regulation-wise to the health technology sector and what is yet to come during the following year. What does the existing and upcoming legislation mean for health technology in Finland? How can we use legislation as a tool to improve the innovation ecosystem in this sector? We interviewed regulatory expert Sandra Liede from Healthtech Finland.

The health technology sector is one of the fastest growing in Finland. The COVID-19 pandemic has certainly not stopped this development, quite the opposite, as the number of e.g. diagnostic tests has increased exponentially during the pandemic. Smarter health and diagnostics together with personalised medicine symbolise the future for healthcare and health technology.

Along with the rapid development of health technology, its legal environment is in a phase of change. The new Finnish Genome Act that will regulate e.g. health-related genetic analyses is currently under preparation. The purpose of the law is to support the responsible, equal and secure use of genomic information. In addition, the Finnish Biobank Act (688/2012) that came into force in 2013 will be updated in order to match other legislation that has come into force after that, such as the General Data Protection Regulation (2016/679 ). Another aim is to make the Act more functional in practice, as there has been a number of practical difficulties involved in applying the Act. Furthermore, the new Finnish Act on Clinical Trials (983/2021) has recently been adopted and will enter into force at the same time as a relevant EU regulation, on 31 January 2022.

Sandra Liede is a regulatory expert at Healthtech Finland that helps the growth and internationalisation of companies in the health technology sector by being a meeting place for companies and developing services for its members. According to Liede, in this extremely regulated field, the legislator should primarily identify all of these laws that are linked together and establish their overall impact on the health technology sector. Liede wishes that the industrial political viewpoint, including e.g. businesses, entrepreneurship and knowledge, would be more visible in law drafting. She further points out that the binding legislation on data processing originates in the EU, and each Member State has limited room for national margin of appreciation when considering additional legislation. Even then, the starting point should be pro-innovation and enabling national policies and legislation. However, this is not enough, and innovation-friendly decisions are also needed, regarding e.g. skills needs, public procurement and official interpretations and regulations. Enabling legislation does not yet mean that it will be easier for products to enter the market if there are barriers on the procurement side.

The domestic market serves as a springboard for companies to the international markets; it is an important reference market. Thus, in this context, an innovation-friendly policy means supporting the access of products to the domestic market in every way possible in order to obtain more export products and thereby return to Finland in the form of tax revenue and employment.

 

Enabling legislation does not yet mean that it will be easier for products to enter the market if there are barriers on the procurement side.

The Biobank Act is an example of a very functional and successful act, says Liede. The Act is also globally unique, as it enables a so-called recalling system to invite people for further investigation. In addition, the processing of samples and related data is largely based on legislation that imposes obligations on biobank operators and provides safeguards to protect human rights and freedoms. The Biobank Act already supports the development of health technology, biomedical research and the utilisation of genomic information. There are many successful co-operation projects in Finland that combine both academic research and product development with the pharmaceutical industry or the health technology sector. The strengths of the Act should definitely be maintained and support the needs of both domestic and international research and product development.

In the preparation of the Genome Act, Liede wishes that the business field would be actively involved. Companies can act as both producers and users of genomic information, but also as technology partners and service providers. The priority should be to identify these different roles. Companies in the genomics industry are often perceived as representatives of the pharmaceutical industry, but the range of knowledge and expertise is much wider than this.

When looking into the future, Liede believes that the first part of the Genome Act, including the foundation of the Genome Centre, will come into force during the upcoming year. The Genome Centre will cooperate with the healthcare sector, biobank actors as well as the business field, so that patients can get personalised therapies tailored for them in the future.

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