Equality has long been a deeply held ideal in Norway, where the concept of allemannsretten – the legal right to roam – permeates all aspects of society. Notably, surplus wealth produced by Norway’s sizeable petroleum industry is deposited into the Government Pension Fund Global, today the world’s largest sovereign wealth fund, which holds 1.4 percent of every listed company in the world, 2.5 percent of every European stock, and is worth over USD 1.3 trillion, according to the Financial Times.
This sagacity has translated into Norway’s 5.3 million inhabitants now enjoying the world’s fourth highest per-capita income, highest Human Development Index ranking, and a comprehensive universal healthcare system that guarantees high-quality care for all segments of the population. Moreover, as the country’s Global Health Ambassador John-Arne Røttingen points out, despite its relatively small size, “Norway is an important player in global health on the international stage and has been instrumental in establishing several global health institutions such as Gavi, the Vaccine Alliance 20 years ago and was also an early supporter of the Global Fund to Fight AIDS, Tuberculosis and Malaria. More recently, Norway played a central role in setting up the Coalition for Epidemic Preparedness Innovations (CEPI).”
However, questions are being asked as to whether this commitment to equality is damaging healthcare outcomes. A fragmented hospital system where procurement decisions are often made on price alone coupled with the lack of a strong innovative domestic pharmaceutical industry akin to those in neighbouring Denmark and Sweden has left Norwegian patients often struggling to access latest generation treatments. Clinical trial numbers have also been on the wane in recent years, with multinational companies increasingly looking towards more innovation-friendly markets to test new drugs.
Norway is an important player in global health on the international stage and has been instrumental in establishing several global health institutions
Despite these challenges, signs are afoot that the Norwegian state is cognizant of the importance of systemic change, including working more closely with the private sector, to solve some of its most pressing healthcare problems. The 2019 Government White Paper on the Health Industry outlines the basis for closer public-private collaboration and includes plans to make Norway more of a clinical trials hub. Additionally, The National Health & Hospital Plan 2020-2023 is attempting to coordinate the country’s regional hospitals and fast-forward the healthcare system’s digitalisation process.
Norway’s boasts a modestly sized EUR 3.7 billion pharma market but has seen annual growth of EUR 430 million since 2014 and excellent fundamentals are in place for greater industry investment. These include the country’s comprehensive system of digital patient records, strong basic research footprint in oncology and neuroscience, and excellent human resources. It now remains to be seen whether Norway can step out from the shadow of its flagship oil and gas industry and build an internationally competitive life sciences ecosystem of its own.
Healthcare: Universal, but Fragmented
Norwegians live longer and healthier lives than many of their European counterparts, with low alcohol consumption thanks to stringent government measures and low obesity rates contributing to an average life expectancy of 83 years. Mortality rates from preventable deaths are well below the EU average and cancer survival rates are substantially higher, reflecting earlier diagnosis in some cases and effective treatment once diagnosed. However, this impressive performance comes at a cost, with Norwegian healthcare spending amounting to 10.5 percent of GDP per capita, above the EU average of 9.8 percent.
As Janssen Country Director Mario Klesse, a recent implant to Norway, exclaims, “Norway is highly developed and very well organised. This has been evidenced through the country’s measured and structured reaction to the COVID-19 pandemic. In terms of healthcare, Norway’s deeply rooted principle of equality is apparent, and the country boasts a very developed system with top-class healthcare facilities, transportation, and infrastructure to serve what is a geographically large area.”
However, the decentralised nature of Norwegian healthcare – where the state takes responsibility for specialist care and municipalities for primary healthcare, long-term care, and social service – throws up several challenges, not least of individual hospitals and municipalities making procurement decisions based on short-term, cost-saving goals. As Erik Jacobsen of consulting firm Menon Economics outlines, “hospitals and the largest local communities are the most important players for building a vibrant home market, as it is they, rather than politicians, that make procurement decisions. However, the organisational structure of these hospitals is an obstacle as they have strict hierarchies and fragmented decision making. Therefore, hospital reform is key.”
Jacobsen continues, “many of the large governmental customers do not really understand how they can become demanding, sophisticated customers of new technologies and solutions, both to increase their own innovativeness and productivity and to help private companies. Procurement decisions are not taken by top executives at the head porter level, but in single units within single hospitals, leading to a fragmented decision-making process.”
The National Health and Hospital plan calls for an increased use of new technologies and there is also a majority within the government advocating for the use of personalised medicine and Real-World Data (RWD) in Norway’s national healthcare system
To its credit, the Norwegian government seems to be cognizant of the need for reform of its fragmented healthcare and is currently rolling out the ‘Norwegian National Health and Hospital Plan 2020-2023’, with the aim of creating a more sustainable, digital, and patient-centred system. A central goal of the Plan is to improve care coordination by organising hospitals in regional networks across a country that, while sparsely populated, is geographically huge. Each network is expected to include a regional hospital (one in each regional health authority), larger acute care hospitals (providing specialised emergency care to a population of about 60,000 to 80,000 people) and hospitals providing acute care and elective surgery.
Greater uptake of digital systems will also be key to streamlining and connecting hospitals and municipalities. As Karita Bekkemellem of national pharma industry association LMI explains, “Norway’s healthcare system needs to start using new technologies that increase efficiency and productivity … the National Health and Hospital plan calls for an increased use of new technologies and there is also a majority within the government advocating for the use of personalised medicine and Real-World Data (RWD) in Norway’s national healthcare system. The government now believes that these technologies will play a fundamental role in ensuring the sustainability of the healthcare system here.”
Access, Pricing & Reimbursement Challenges
Moreover, despite Norway’s high overall healthcare spending per capita, there has been a gradual decline in the share of health spending allocated to pharmaceuticals over the past decade, which now stands as the second lowest in Europe after Denmark. “There is perhaps a political explanation for this,” posits GSK General Manager Christian Probst, “with the government looking to save money on pharmaceuticals rather than increased efficiency in the health system.”
This is impacting the ability of innovative new treatments to reach the market according to Kirsti Nyhus, market access & external affairs director for Scandinavia and country lead Norway at AbbVie. “Cost containment on pharmaceuticals in Norway is much higher than in other areas, which leads to innovative new treatments taking longer to get to the market,” she laments. “Many of these treatments are either rejected and do not make it to market at all or have restricted access.”
The strong notion of equality in [Norwegian] healthcare can lead to some challenges
The principle of equality on which Norwegian healthcare is built is also impacting access. As GSK’s Probst explains, “The strong notion of equality in [Norwegian] healthcare can lead to some challenges. For example, getting compassionate use authorisation in Norway is tricky as it implies selecting one group of patients over another.”
Hilde Bech, general manager of BMS continues, “the equality embedded in Norway’s politics means that any new drug has to be available to everyone, independent of how much you earn or where you live. This means that any decision to bring a drug to market is a highly political decision made for everyone and is carried out as part of a national conversation.” Bech does note that this process has both an upside – “once a drug is approved in Norway, there is widespread uptake and usage,” as well as the downside that “gaining approval is an uphill struggle.”
Another access issue is the ‘equal enough’ principle whereby pharmaceuticals are clustered into ‘scientifically equal’ bundles. AbbVie’s Nyhus outlines that “Innovative, generic, and on-patent treatments are bundled together even though they may have different outcomes. Then they are procured based on price alone, even though the quality criteria is completely different. This system is not very innovation friendly, is harmful for Norwegian patients who miss out on accessing better-quality treatments and is ultimately bad for the healthcare system.” Janssen’s Klesse agrees that this ‘equal enough’ principle “can lead to sub-optimal treatment sequences where physicians may need to cycle through a row of treatments that are not effective or suitable for the individual patient, before they can actually use what this patient really needs.”
The advent of highly specialised precision medicine means that reform of the ‘equal enough’ principle is especially pressing. “Pharmaceutical science is rapidly shifting towards highly individualised medicine,” explains Klesse. “In cancer treatment, it is critical that physicians can freely choose the right combination regimens for their patients. Cell therapies are on their way, and there are more products which have one specific target in a disease pathway but also have multiple indications. In our view, the current system is not adequately prepared for those new paradigms. Hence, we will only see the massive advantages of individualised medicine in Norway when we really change the system.”
Philipp Maerz, head of Merck’s Nordic and Baltic operations is also worried that a lack of understanding on how best to characterise the value of new therapies may mean that Norwegian patients risk missing out on them altogether. He elucidates, “There is work to be done in Norway to explain to politicians, the Norwegian Medicines Agency and other stakeholders why meeting evidence requirements is more difficult today than it was before due to the characteristics of personalized medicine. If we do not find a way to assess the value of the modern therapy, it will keep on prolonging reimbursement discussions and delay access to innovative treatments for patients.”
HTA: Digging into Real-World Data
One way in which access to innovation could be expedited is through the greater use of data in the drug evaluation process. For example, Norway boasts 53 national quality registries dating back decades and annually collects some 174 indicators across different levels of care, which could be better utilised in health technology assessments (HTAs).
Nyhus of AbbVie is convinced that Norway’s strong data footprint can be a key piece in the access puzzle. “Norway has the opportunity to use its registries, pilot pay for performance schemes, and initiate innovative contracting,” she states. “This will mean that payment is only made when something works, uncertainty is removed, and patients can access the best treatment possible.”
Norway has the opportunity to use its registries, pilot pay for performance schemes, and initiate innovative contracting
However, currently, as GSK’s Probst notes, “Norway is quite risk averse in the evaluation of health economic data. This makes it difficult to introduce new innovations to the Norwegian market, especially if all the data requested is not yet available, with price becoming often the only measure to mitigate uncertainties in the data. For this reason, many new drugs are rejected, limiting patient access to new treatments.”
He goes on, “There needs to be more thought about different HTA models and the use of real-world evidence (RWE), including pay-for-performance. The Norwegian authorities are slowly opening up towards these more innovative models, but we as an industry also have to have more input in order to increase their trust in us.”
The LMI’s Karita Bekkemellem adds, “It is critically important that we can access and utilise RWD, as it enables great opportunities for a more efficient and improved healthcare service for patients as well as for industry development…We need a new and improved dialogue on how we can utilise health data to everyone’s benefit in the regulatory processes.”
Swiss national Probst is cautiously optimistic about increasing openness to new models in Norway. “Having been in the country for five years, I have seen a lot of progress be made, but there is still a reluctance to embrace innovative pricing models,” he sighs. “However, recently, there have been some signals that the centralised hospital procurement body, which is responsible both for the procurement of drugs as well as execution, is now more open to new payment solutions. Here also seems to be an opening to explore public private collaborations and partnerships in line with what is being done in other European countries.”
Research: Building Blocks & Translational Hurdles
With strong fundamentals in place and an increasing governmental prioritisation of healthcare, Norway is trying to stake a claim as a research hub able to compete with the more established innovation ecosystems in neighbouring Sweden and Denmark. The Research Council of Norway alone directly invests over NOK 10 billion NOK (EUR one billion) per year and handles the R&D tax incentive scheme, worth around NOK 5.5 billion (EUR 0.52 billion), on behalf of the government.
As the Council’s Anne Kjersti Fahlvik points out, “Health is the largest focus area for public R&D in Norway even though we do not have a strong industrial tradition in this field. There is a lot of activity taking place among research groups and hospitals in Norway, plenty of excellent research, and a growing number of start-up companies as well as some more established and internationally oriented businesses.”
Other stakeholders are also optimistic on Norway’s research potential but keen to keep expectations in check. “Being a small country of five million inhabitants, it is not probable that the next global medical breakthrough will come from Norway,” admits Ole Alexander Opdalshei of the Norwegian Cancer Society. “On the other hand, we have a lot of good health registries as well as a universal healthcare system and a lot of good researchers that publish at a high level and collaborate with researchers at other international cancer research institutions.”
Norway is not so strong at bringing new biotech inventions into companies, and letting those companies grow. We lack a big milieu that could actually take these ideas and bring them to markets
What Norway perhaps lacks is a national champion able to translate the country’s solid basic research footing to international commercial success. Jon Amund Kyte, head of the Department of Experimental Cancer Treatment, OUH Comprehensive Cancer Center at Oslo University Hospital points out that “Norway is not so strong at bringing new biotech inventions into companies, and letting those companies grow. We lack a big milieu that could actually take these ideas and bring them to markets. Norway does not have this milieu because it does not have a big biotech or pharmaceutical company.”
The Oslo Cancer Cluster’s Ketil Widerberg agrees. “Many ideas and projects have not materialised. In Norway researchers explore something new and often, once they discover how it works, become disinterested and move on to something else. We need people who are willing to look at how this knowledge can be applied and how it can be useful in a clinical setting.”
Menon Economics’ Jacobsen believes that this lack of translational success is tied to the country’s traditional focus on business-to-business (B2B) industries like oil and gas. He explains, “The major issue is that Norway has much more success in developing technologies and solutions than in commercialising and scaling them up, something which is tied to the B2B orientation of our economy. Norwegian companies tend to have few customers, but those they do have are often large global players. Norway has not had to become adept at consumer-based marketing; it has been enough to deliver high quality products and target customers around the world.”
Jacobsen adds, “There is a lot of interest and attention on the health industry from both the public and private sides. However, that does not necessarily mean that we have the necessary knowledge and tools to transform all of the promising small innovative companies into international success stories. There is still somewhat of a lack of understanding, tools, and incentives for widespread commercialisation and internationalisation scale-up.”
A similar story rings out in the medtech sector. Bulbitech’s Dennis Hens explains that while “Norway is a very good country to start projects with a very attractive investment landscape at the pre-seed and seed stage, at later stages of a company’s development things get more difficult. Norway only has a population of five million and there are not a lot of specialised medtech and biotech venture capitalists (VCs) or private equity. Therefore, most major investments are made through investment bankers with international networks or via syndication partners. There are a few good potential investors in this field but finding investment can feel like looking for a needle in a haystack.”
Hens continues, “Additionally, many of the investment banks that we talk to are willing to invest in biotech or medtech but have traditionally been focused on Norway’s more well-established industries of forestry, agriculture, fishing, and oil and gas. Therefore, there is a need to educate them about the steps that need to be taken to become a mature medtech company. That is something that could really be improved in Norway.”
Perhaps the closest thing to a Norwegian success story is Photocure, a drug/device hybrid company focused on bladder cancer, with significant US and European operations and ambitious expansion plans for Asia and Latin America. As the company’s American CEO Dan Schneider exclaims, “The Norwegian life sciences sector, although strong in oncology, is largely still in its commercial infancy compared to countries like Sweden, UK and US. However, the Norwegian people are extremely smart, and the country boasts great scientists and science. They just need a more commercial mindset and experience to capitalize on their great discoveries.” Schneider concludes, “We are a flagbearer for all Norwegian life sciences firms moving from development to commercialisation and a prime example of what the future could look like for them.”
The Norwegian life sciences sector, although strong in oncology, is largely still in its commercial infancy compared to countries like Sweden, UK and US. However, the Norwegian people are extremely smart, and the country boasts great scientists and science. They just need a more commercial mindset and experience to capitalize on their great discoveries
Widerberg is also keen to note some of the success stories that have emanated from the Oslo Cancer Cluster, which works on building incentive structures for academics and researchers to move into translational research. “Thermo Fisher Scientific’s ‘Dynabeads’ technology that makes faster and cheaper DNA-sequencing accessible was tested and developed here,” he notes. “Moreover, Bayer’s USD 2.9 billion acquisition of Algeta in 2013 was a major boost to the Norwegian economy. Norwegian translational research is having a real impact on both patients and the country’s overall economic standing.”
Bayer’s Jan Børge Jakobsen adds, “There are also a large number of innovative companies here within medtech and digitalization. Some of these have already entered the international scene, while others will follow. For example, Vaccibody has recently entered an agreement with Genentech to develop DNA-based individualized neoantigen cancer vaccines. Another example, Hy5, a company that has developed a hydraulic hand prothesis, has received grants from the EU Fast Track to Innovation program.”
Clinical Trials: Decline & Fundamentals
The other key piece of the research puzzle in Norway is clinical trials, which have been in slow decline over the past 11 years, down to 120 applications in 2019 from a high of 177 in 2008. With a relatively small population, high running costs, difficulties accessing data, and access issues post-approval, it seems that industry sponsors are increasingly looking elsewhere to trial new treatments.
However, with the right framework in place, many Norwegian industry stakeholders are confident that Norway has all the fundamentals – not least the country’s patient registries – to be a leading clinical trials hub in Europe. As Ketil Widerberg of the Oslo Cancer Cluster proclaims, “Norway is one of the leading countries in the world in terms of electronic health records. For example, our cancer registers go back 50-60 years and represent excellent resources to draw on for researchers who are developing the next generation of efficacious cancer treatments. With the need for more RWD to prove the efficacy of drugs, both individually and in combination with other therapies, more and more firms will look towards countries like Norway with excellent electronic health records.”
Jon Amund Kyte, who himself leads clinical trials on advanced cancer therapies at Oslo University Hospital, outlines some of Norway’s other key selling points to attract clinical trials. “One of the most important factors is our ability to do long-term follow-ups,” he states. “If you start a trial in the US, you have to recruit considerably more patients than you are actually aiming to get the data from. In Norway, you will get the data and the follow up for almost all participants. The reason for that is the strong national healthcare system with no private alternative. Even if people move around Norway, they will still be within the national healthcare system, so we do not lose patients. Our registries, including the Norwegian cancer registry, could also be useful for companies looking to extract RWD on patients.”
Our cancer registers go back 50-60 years and represent excellent resources to draw on for researchers who are developing the next generation of efficacious cancer treatments
Kyte concludes, “Another key factor is Norway’s highly educated population that speaks good English, which is useful for international studies, as they are able to understand and closely follow instructions, including the reporting of side effects.”
GSK’s Christian Probst adds that “Norway’s patient registries are like gold in health data terms. This is an advantage of the country’s centralisation, but also of Norwegian society’s openness to digital tools.” Probst does however point out that “the clock is ticking on fully utilising this resource, as Norway is not the only country in the world with such data sets. Nevertheless, I do see a greater sense of awareness and urgency about the importance of these resources if Norway is to build a stronger domestic health industry.”
For Renée C. Amundsen, now global head of business innovation at Merck Healthcare, but formerly in charge of operations for Nordics and the Netherlands, “Norway is the perfect location for clinical trials thanks to its high-quality patient registries, where every patient has a unique identity number.” She adds, “now, we simply need to make Norway an attractive country in which to run clinical trials. Incentives need to be created at the clinical level and we need to ensure that patients benefit from clinical trials and have access to the innovative treatments that are being tested.”
Janssen’s Mario Klesse adds that a framework needs to be put in place for private sector access to data. “The Nordic countries have a strong history in patient and population registries and we already conduct RWE studies in Norway, but there is a pressing need for a pragmatic framework on how the industry can better access this data. This will be crucial for both research purposes, and also for enabling outcome-based access schemes without adding administrative workload. There is great potential for more PPPs to solving some of these data integration puzzles.”
One of the key issues restricting a resurgence of Norwegian clinical trials is market access. AbbVie’s Kirsti Nyhus exclaims that “global companies need to place clinical trials in countries where they can actually use the drugs when the trial stops. If a country is not willing to procure a drug post-trial, the trial will not be based there. Moreover, some clinical trials require a best-in-class competitor. If that competitor is not being used in a country’s clinical practice, then it will not be eligible as a trial location.”
Janssen’s Klesse agrees. “A stronger clinical trial footprint is also connected with market access; while we place clinical trials under global scientific and feasibility considerations, the question whether a drug can be used afterwards is also an ethical consideration,” he notes.
More dialogue and collaboration between the public sector and a private, for-profit, sector that has often been viewed with suspicion in Norway is also crucial. As Karita Bekkemellem of the LMI concedes, “there is still a perception amongst some that pharmaceutical companies are seeking to take advantage of the Norwegian healthcare system.”
She continues, “The Norwegian government gives Norwegian hospitals nearly NOK 20 million (EUR 1.79 million) each year to spend on clinical trials. LMI has been working closely with hospitals to demonstrate ways through which hospitals can spend this money effectively and show how clinical trials can lead to earlier patient access to innovative medicines. It is vital that we build partnerships between hospitals and the pharmaceutical industry, to make sure that hospitals and pharmaceutical companies trust each other and that they can work together productively.”
For Bayer’s Jakobsen, it is also of great import that this dialogue takes place at an earlier stage. He outlines, “hospitals and clinics should increase the resources and infrastructure dedicated to managing clinical trials, and companies have to start the necessary dialogue sufficiently early so that clinical trials can be conducted in Norway. There needs to be a common vision within the whole ecosystem. For instance, as a country with a relatively small population, I think it is important that Norway focuses on attracting early-stage clinical trials so we can be involved as early as possible within the drug development cycle and production for clinical supplies.”
Clinical Trials: New Beginnings?
To attract clinical trials back to Norway, a ‘Clinical Trial Action Plan’ is slated for publication in the near future signposting the Norwegian state’s increased awareness of this issue’s importance, following on from the 2019 White Paper on the Health Industry which also put clinical trials on the political agenda. Janssen’s Klesse feels that “The Clinical Trial Action Plan sets out a strategy to provide a better environment for clinical trials in Norway and is a remarkable initiative. This plan – when put into action – has the potential to significantly strengthen the position of Norway in the global research landscape. One element that the Action Plan clearly outlines is creating one-stop shops for clinical trials in the country’s leading coordination centres. It is also about providing the right environment to quickly initiate studies, execute them, and then follow-up when trials end.”
GSK’s Probst also sees a greater governmental willingness to change the situation around clinical trials for the better. “One element of the 2019 White Paper was concerned with attracting clinical trials and making sure that Norway’s hospitals have the resources necessary to run them well and adequately prioritise them. In the past, public-private collaborations and partnerships were seen negatively in Norway and, although we are not yet at the final destination, huge progress has been made. We welcome this progress and encourage authorities to continue to move in that direction.”
[The Clinical Trial Action Plan] – when put into action – has the potential to significantly strengthen the position of Norway in the global research landscape
He continues, “GSK Norway is also working hard with our R&D colleagues to attract trials to Norway, which is often more difficult given the challenges that exist here. We are also looking not only into clinical trials per se but also how we can partner with experts on investigator-initiated projects. A lot of very positive change is occurring. Three years ago, we met with the industry association and the heads of the key university hospitals who told us they lacked the resources to conduct clinical trials as they were not being paid extra for them. Now, with clinical trials becoming more prioritised from a political health perspective, a huge switch has occurred, and Norway’s excellent clinicians and researchers are now being better utilised. Even the scepticism about public-private collaborations is decreasing somewhat.”
Plans are also underway for greater collaboration with Norway’s Nordic neighbours on clinical trials. Although Norway’s population is a small 5.3 million, taken together with the populations of Denmark, Finland, Iceland, and Sweden, this number reaches a much more significant 27.4 million and consequently a much larger potential trial participant population.
“The potential is there for really good Nordic collaboration, partly because the healthcare systems are so similar, as well as the fact that in all the Scandinavian countries, apart from Finland, we understand each other, proclaims the OUH’s Jon Amund Kyte. “The aim should be for the Nordics to become one region for clinical trials, so that Norwegian patients can go to Sweden and Swedish patients can come to Norway, for example. That would help us a lot, but it would also be advantageous for patients because they would then have much more choice about which trials to enter.”
The Oslo Cancer Cluster’s Widerberg expounds, “Each country wants to develop their own industry, but also needs to stand together. For example, if a US company wanted to use new innovative ways to work with health data in clinical studies, the Nordic countries would need to come together to present a unified offer, since each individual country’s population is too small to be really attractive. This is especially true for precision medicine, where you need a population base of at least 20 million. Our national strategies may not necessarily be perfectly aligned, but there is an understanding – strengthened by innovation centres such as Oslo Cancer Cluster – that the Nordic countries need to work together.”
However, Kyte reveals that there is still a long road to travel to achieve this collaborative future, despite initiatives like Nordic Nect, a pan-Nordic network for early cancer trials. “The Nordic region is not working well in terms of clinical trials, with the main problem the question of who covers travel expenses not covered by the trial itself,” he notes. “In some cases, the pharmaceutical companies cover everything, but in most cases, the hospital in either Sweden or Norway would have to cover some costs. Then there is also the problem of insurance, as insurance only covers patients in their own country. All of these questions are unanswered, and what usually happens is the patients never go to Sweden for that trial, because neither the doctor nor the patient has the time or energy to work out a special solution.”
Is Norway’s Time Nigh?
After years of focus on the oil and gas and fishing industries, healthcare research and innovation is now finally high on the Norwegian government’s priority list and looks set to stay there through the election year of 2021 and beyond. Norway has already proved itself to be a worthy contributor to global health via its prominent role in the foundation of various international organisations and, with the country less badly ravaged than some other European nations by the COVID-19 crisis, perhaps the time is nigh to finally catch up with its neighbours in promoting greater public-private sector collaboration and creating a truly conducive environment for access to innovation, translational research, and clinical trials.