Anders Blanck of Lif, the trade association for the research-based Swedish pharmaceutical industry, outlines the steps already being put in place for Sweden to become a leading country in the implementation of precision medicine. Blanck highlights the impact of Sweden’s December 2019 Life Science Strategy – which includes initiatives on molecular diagnostics and treatments, health data, and ATMP introduction – and ends with a rallying cry for continuing stakeholder collaboration to cement the Nordic nation’s leading position in the precision medicine field.
As a Swede, it fills me with pride that Sweden is considered a leading country in terms of innovation. My country has scored very high in a number of international innovation rankings in recent years. Examples of this include leading positions in the EU Commission’s European Innovation Scoreboard for 2019 and 2020 and the number two position (after Switzerland) in the Global Innovation Index for 2019 and 2020. Sweden also came out as the leading country in the Networked Readiness Index for 2020. In addition to this – but maybe with a more national perspective – Swedish pharmaceutical exports have risen sharply in recent years, with a 28 percent increase in 2019 and a further 24 percent increase during the first eight months of 2020.
This truly puts Sweden in a favourable position when it comes to taking on the opportunities and challenges of implementing precision medicine, with its promise to really transform future healthcare as well as the entire life science sector. But it also gives Swedish decision makers confidence that they will actually be able to take the lead in precision medicine.
Just before the COVID-19 pandemic, Sweden launched its first ever national Life Science Strategy. The Strategy is broad, with 30 objectives in eight priority areas covering the strengthening of academic research, facilitating collaboration between academia and industry, attracting more industry initiated clinical trials, and the continuous skills development needed for precision medicine and highly advanced production of pharmaceuticals and medtech devices.
One of the objectives of the Strategy is for Sweden to be a leading country in the implementation of precision medicine in healthcare. Given the highly decentralised Swedish governing model – with independent government agencies and autonomous regions and local authorities with responsibility for healthcare and elderly care – this is perhaps one of the more challenging of the Strategy’s objectives. The national Government is therefore very active in its use of various tools to support and incentivise the regional and local levels to increase the speed and intensity of their work and thereby realise the potential in precision medicine.
Even though Sweden has been heavily affected by the pandemic, the Swedish Government has taken a number of initiatives to facilitate and speed up the implementation of precision medicine. In mid-December 2020 the Government presented to Parliament the Research and Innovation Bill for 2021-2024 which – among other things – gives direction and allocates funding for some of the most important precision medicine initiatives in line with the Life Science Strategy. In addition to the Bill, the Government has decided on a number of specific precision medicine assignments to the national agencies. In combination, these initiatives should pave the way for the regions’ and local authorities’ own actions to transform the promises of precision medicine into real patient value.
To give you a flavour of the initiatives now taken, I would like to share some examples from the key areas identified in the Life Science Strategy: development and spread of molecular diagnostics and treatments; access to and use of health data; and effective introduction of ATMPs in healthcare. I believe these examples illustrate both the complexity in implementing precision medicine and the ambitions and breadth of the Swedish initiatives.
One of the most interesting initiatives is Genomic Medicine Sweden (GMS), which is a collaboration between Sweden’s seven regions with university hospitals and the seven universities with medical faculties. GMS’s strategic mission is to foster collaboration between healthcare providers, academia, and Life Science companies, and realise precision medicine by effectively utilising rapidly advancing sequencing technologies to provide the highest standards of genomic testing in routine healthcare throughout Sweden. The initiative is funded jointly by the Swedish Government, through the national innovation agency Vinnova, and the seven regions and universities. In the recently presented Research and Innovation Bill, GMS now receives additional government funding for the development of new molecular diagnostics and treatments and for pilot projects on national implementation of genetic and molecular diagnostics in clinical practice.
It is obvious that access to and use of health data is a prerequisite for a successful implementation of precision medicine in routine healthcare. The Swedish Research Council has therefore been assigned to set up an advisory expert function – in support for academic researchers, Life Science companies and other stakeholders – to increase the usability and accessibility of health data, and to identify obstacles that prevent an effective use of health data. With the same purpose, the National Board of Health and Welfare – which is responsible for the national health data registries covering the entire Swedish population – has been tasked with strengthening its registry service function. Combined, these two initiatives have the potential to really improve access to and facilitate the relevant use of all Swedish health data.
One of the more concrete examples of precision medicine, but one that also shows the complexity around practical healthcare implementation, is the introduction of ATMPs (Advanced Therapeutic Medicinal Products). A number of initiatives have been taken recently to strengthen the capabilities in Sweden to develop and produce ATMPs, but also to prepare the healthcare services for the introduction of what are often ground-breaking products.
SWElife ATMP is an initiative focusing on competitiveness in cell and gene therapy and on how Sweden can be an international leader in developing these therapies. The aim is to provide Swedish healthcare, academia and Life Science companies with expertise and competence on topics such as the regulatory aspects of ATMP development and the legal aspects of stem cell-based ATMPs.
Another important ATMP initiative is CAMP – Centre for Advanced Medicinal Products. CAMP aims at establishing a public-private partnership between government, academia, healthcare, patient organisations, and life science companies to accelerate patient access to ATMPs in Sweden. The focus is on establishing strong research and development environments in Sweden to attract international competence and investments, and on developing a national infrastructure to facilitate the commercialisation of ATMPs.
As a complement to SWElife ATMP and CAMP, the national innovation agency Vinnova is also funding a project called ‘Sweden leading in advanced therapies 2030’ with the broader aim of identifying obstacles and solving challenges within the Swedish research and innovation ecosystem in relation to the development of ATMPs. In addition to national coordination and resource concentration, the focus lies on increased capacity for industrial development and production of ATMPs in Sweden, and on increased knowledge building and sharing, as well as ensuring that Sweden can cater to future competence needs.
Finally, one very important aspect of precision medicine in general, and ATMPs specifically, is the healthcare system’s readiness and how patients will actually get access to the new treatments and diagnostic possibilities that the new paradigms bring. Given the regionalised healthcare model and the value-based national pricing system for medicines with a strong focus on cost effectiveness, the Swedish Government has tasked some of the national agencies with looking into different practical aspects around the introduction of precision medicine and ATMPs in Swedish healthcare. The Swedish Agency for Health and Care Services Analysis is analysing the impact of precision medicine on healthcare. TLV (The Dental and Pharmaceutical Benefits Agency), which is the Swedish pricing and reimbursement agency, is reviewing how health economic assessments can be developed for precision medicine and how future payment models for ATMPs could be designed to balance support for innovation with cost control and budget predictability. In parallel to the TLV assignment, SALAR – the organisation for regions and local authorities – is, in collaboration with TLV, preparing for pilots with new payment models for ATMPs. This will most likely be done through new forms of managed entry agreements between regions and pharmaceutical companies.
To conclude, Sweden is definitely getting its act together to broadly implement precision medicine and is taking on the international challenge to be the leader in this field. If you ask me, the only way a small country in the northern outskirts of Europe can live up to this aspiration is to muster all positive forces in the country to work collaboratively for the benefit of patients and the national health and wealth. Traditionally, such a collaborative approach has been one of Sweden’s strengths. Sweden is definitely not one of the biggest countries in the world, but it can be one of the smartest!