Sweden’s USD 4.8 billion pharmaceutical market, its population size of 10 million and marginal positioning on the northerly fringe of the European Union all belie a legacy as a real titan of life sciences.* The country that has introduced some of the most impactful healthcare inventions of the 20th century – whether that be the implantable pacemaker, the first artificial kidney, the respirator, or the gamma knife – clearly manages to punch well above its weight.
Moreover many of the sector fundamentals look sound. “Sweden boasts a long and proud tradition in science, research and development which has seen it consistently ranked among the most pioneering countries of the world, and considering its maturity, the local pharma market is experiencing a healthy growth rate, with IQVIA predicting an estimated laudable four percent average annual growth until 2022,” ventures Anders Blanck, director general of LIF, the trade association for the research-based pharmaceutical industry.
[Sweden is] consistently ranked among the most pioneering countries of the world
But whether the country can continue to maintain such a tempo of excellence in an era when medical science is becoming ever more sophisticated and integrated with other disciplines remains to be seen. “The world around us is on the move, so business as usual is no longer an option,” cautions Catarina Andersson Forsmann, director general of the national regulator, the Medical Products Agency (MPA).
“I would say Sweden’s greatest asset is its insatiable appetite for innovation and a supporting cast that boasts world-class academic institutions such as Lund University, Gothenburg University and the Karolinska Institute,” affirms Niels Abel Bonde, managing director of Novo Nordisk, a high flying Danish midcap already collaborating extensively with these innovation hubs on bleeding-edge research into stem cell-based treatments for Alzheimer’s.
Swedish people are eager to change the world, not solely in healthcare, but across the entire board
“While I already appreciated Sweden as a very innovative country, I did not realize just how true it was until I moved here,” exclaims Bayer’s regional manager for Scandinavia, Tomer Feffer. “When you reside in Stockholm, you can feel this innovative pulse everywhere. Swedish people are eager to change the world, not solely in healthcare, but across the entire board. More importantly, they are doing so with a social purpose, and know how to execute the ideas that they come up with,” he enthuses.
Certainly the statistics seem to bear this out. The country currently ranks second in WIPO’s worldwide innovation index, 21 percent of the employees of the Swedish pharmaceutical industry are working in R&D and the research intensity of the local sector is between six and ten times higher than in the economy at large. Little wonder, then, that so many international originator pharma firms come to Sweden looking to pick up assets or engage in joint research initiatives.
“Our local affiliate very much acts as a scout on the ground for promising biotechnologies that might be of interest for the global R&D organization. While promising biotech innovations can, of course, sprout from anywhere, statistically speaking the likelihood that something will pop up from Sweden is relatively higher than in other countries so we encourage everyone working here, especially the medical and market access teams, to keep an ear to the ground,” confides Feffer.
Some players, like Merck KGaA, have even institutionalized the process. “For the past three years, we have been pursuing a collaboration with Epicenter, a platform within the Centre for Molecular Medicine, meaning that we maintain a space inside the center to work with small start-ups developing new products and solutions, which could add to our business,” reveals Anders Wesslau, managing director for healthcare. “Since then, we have already attained some quick wins such as collaborating in the development of the first digital contraceptive and a robot for diagnosing diabetes, both of which we have exported to the rest of the Merck network,” he adds.
Swedish excellence in life sciences is internationally recognized
This also explains the perpetual flurry of activity around Swedish M&A activity in the life science space. “Since the 2000s, the Swedish life sciences industry has witnessed a great many mergers and acquisitions targeting national champions like AstraZeneca, Pharmacia, and more recently Meda. On one hand it demonstrates that Swedish excellence in life sciences is internationally recognized. On the other, it also means that Sweden no longer has a national champion to propel its ecosystem like other European countries,” reflects Anders Ekblom, LEO Pharma’s vice chairman of the board.
A Unique Spirit of Collaboration
What perhaps sets apart Sweden from other illustrious life science innovation nations, however, is the distinctive spirit of collaboration that infuses almost all interactions. “The Swedish enjoy a long tradition of working harmoniously, and this dates right back to the early fifties and sixties. During that time, there was already an intense collaboration between companies and academia, which had deepened naturally over time,” narrates Göran A. Ando, former chairman of Novo Nordisk.
The Swedish enjoy a long tradition of working harmoniously, and this dates right back to the early fifties and sixties
“A number of inventions from the Swedish powerhouses, including Astra, Pharmacia and Kabi, were a result of basic research and long collaborations with scientists and institutes before they developed them into commercial successes. From a research standpoint, this system is immensely valuable and ensures the triangle of communication between hospitals and clinics, academic research and commercial companies is strong. This triple-helix existed very early on and is of huge benefit to all three parties,” he opines.
Many others agree. “Frankly what I find most impressive is precisely this unprecedented culture of joined up action…wherever I have worked in the past, including across Asia, I have never seen the industry being as well-respected and engaged as it is here where everyone gets together to collectively shape the future,” concedes Iddo Leshem, general manager for the Nordics at Bristol-Myers Squibb (BMS).
Wherever I have worked in the past, including across Asia, I have never seen the industry being as well-respected and engaged as it is here
“This is a crucial advantage for Sweden that should not be underestimated as we ultimately come away with better solutions by cooperating. By pooling our resources together, we can unleash great creativity and, as an industry undergoing such change and renewal, the advantages of doing so have never been more apparent,” attests Martin Tenlen, general manager for the Nordic Region at CSL Behring.
Danish medical dermatology specialist LEO Pharma has been quick to leverage partnerships and collaboration throughout Sweden. General Manager Nordics Klaus Abel, who sits in Sweden, exclaims, “We welcome partnerships with patient organizations and advocacy groups. The LEO Innovation Lab is developing tools to help patients have the best quality of life possible, despite their disease. For example, we are developing communication tools for interactions between patients and physicians, increasing the ability of physicians to give accurate diagnosis and treatment.” Abel continues, “Together with the University of Copenhagen, the LEO Foundation founded a skin immunology research center, funded with DKK 4 million (USD 600,000), aimed at strengthening research in skin diseases.”
Right now we find ourselves participating in an incredibly exciting R&D project called ReproUnion which is effectively a cross border effort within the field of reproductive medicine
This spirit of open-door collaboration even extends beyond national frontiers to include entities from neighbouring countries too. Testament to this has been the establishment of Medicon Valley, a fully-fledged bi-national life science cluster straddling Eastern Denmark and Southern Sweden that has been become the epicenter of all manner of novel medical advancements. Peter Marcusson, the general manager for the Nordics at Ferring gives an insight when he recounts his company’s experience. “Right now we find ourselves participating in an incredibly exciting R&D project called ReproUnion which is effectively a cross border effort within the field of reproductive medicine where Danish and Swedish universities, hospitals and industry actors across Öresund are all teaming up together to provide leadership in overcoming fertility through the design and delivery of cutting-edge modern assisted reproductive technologies,” he exclaims.
Clinical Trials: Ready to Regain a Competitive Edge?
Underscoring Sweden’s stellar innovation reputation has traditionally been the country’s longstanding capabilities as a premium clinical trials destination. A marked decline in the annual volume of in-country trials conducted has thus been the source of much hand wringing and soul searching on the part of the local life science community.
“Back in the mid 2000s, Sweden was an uncontested world leader in the number of industry-sponsored clinical trials as well as in the number of patients enrolled in clinical trials relative to its population. Unfortunately, there has been a reversal since that golden period. Sadly, the number of industry-sponsored clinical trials has more than halved in the space of only a decade,” recounts LIF’s Anders Blanck.
Sweden has successfully identified the recipe to weave strong links between industry and academia, and now needs to chase that up by involving the healthcare system in our efforts to promote clinical research
Göran Ando, former chairman of Novo Nordisk, is even more forthright in his assessment. “Clinical research in Sweden enjoys an incredible reputation which remains intact today. Let’s not forget that our nation was one of the early pioneers in large clinical studies, examining fundamental treatment options that resulted in worldwide changes of practice in the treatment of myocardial infarction and other cardiovascular conditions. Unfortunately, the large, groundbreaking studies have diminished year on year for a while now, and it is imperative that we find a way to turn this situation around,” he declares.
The precise reason for this loss of competitiveness remains hard to pinpoint. “It’s certainly not owing to a paucity of patients, or lack of interest from industry, but more likely to be the result of healthcare practitioners having little time to devote to trials and the fact that companies are forced to fulfill preconditions that do not exist in other countries, such as the fact that all medicines must be dispensed in pharmacies making it impossible to distribute medicines directly to the clinical site,” hypothesizes Blanck.
Some analysts suggest that the ethical agreements need to be re-written while others are appealing for greater incentives for medical staff to participate in trials. “Right now, the performance of hospitals is mainly measured by the ability to produce healthcare while research and clinical studies play second fiddle. Sweden has successfully identified the recipe to weave strong links between industry and academia, and now needs to chase that up by involving the healthcare system in our efforts to promote clinical research,” conjectures Helena Strigård, director general of SwedenBIO.
For all of that, however, many MNCs appear highly enthusiastic about the country’s clinical research ecosystem. “Our Swedish affiliate is currently part of 20 global clinical trials, is conducting two local clinical trials, and is enrolling a total of 200 patients. Our volume of studies year on year remains stable, and we have even established a dedicated clinical study unit based out of Stockholm which supports our clinical studies throughout the entire Nordic-Baltic region from Phase I to Phase IV,” reports Sanofi’s country chair, Anna-Kaija Grönblad.
Swedish clinics are now participating in one-fourth of Pfizer’s global clinical trial program
Nor is this sort of narrative an exception. According to Pfizer’s country manager, Malin Parkler, “Swedish clinics are now participating in one-fourth of Pfizer’s global clinical trial program” and the company values Sweden as a serious and competent clinical research base ready to handle studies of high strategic importance. “We are especially proud that Sweden is the only country outside the US conducting our critical investigations into the next generation of pneumococcal vaccines,” she adds.
Meanwhile Berkeley Vincent, managing director for the Nordics and Baltics at Janssen, confirms that “a full 20 percent of all global clinical trials conducted by J&J’s pharma business have Nordic sites, with approximately 40 ongoing Janssen studies in Sweden.” “In a relatively small country of only ten million people, having this many patients undergoing studies shows how profoundly invested we are in the local research ecosystem,” he argues.
A full 20 percent of all global clinical trials conducted by J&J’s pharma business have Nordic sites
CSL Behring, the market leader for the plasma protein segment is yet another heavyweight player that places great emphasis on leveraging the Swedish clinical research ecosystem. “We have been collaborating significantly to deliver evidence through clinical trials here locally and see Sweden as an appropriate location for some of our most important trials. For example, we participated in the world’s largest study ever in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), an extremely debilitating disease, in which the body attacks its own nerves,” remembers the company’s general manager for the Nordics region, Martin Tenlen.
Moreover, it is clear that the Swedish authorities will be pulling out all the stops to ensure that the country retains its status as a preferred clinical research destination. The Region of Stockholm, for example, has pledged to increase clinical trial numbers by 50 percent by 2022. “We are committed to simplifying and streamlining the process by which companies apply for trials so as to render it much more user friendly. We intend to achieve this by establishing a one-stop shop which will give a response within ten days if we are prepared to start the validation process,” boldly proclaims the region’s chairwoman, Irene Svenonius.
This radical overhaul of our healthcare apparatus will necessarily impact the manner in which research is conducted
Meanwhile intense efforts are underway to integrate healthcare and research in state-of-the-art facilities that can handle high-end, complex R&D initiatives. “My priority has been to ensure that the massive investment [to the tune of USD 2.42bn] made for the New Karolinska Hospital in Solna generates maximum combined benefits for healthcare, medical research and education, not only for the Stockholm region but the country as a whole… A key part of solving this puzzle has been the establishment within the complex of BioClinicum, Europe’s most modern translational research facility comprising 195 research laboratories where 900 researchers from different specializations work together to implement the outcomes of medical research faster in healthcare,” she enthuses.
“This radical overhaul of our healthcare apparatus will necessarily impact the manner in which research is conducted. Since patients will be treated at a range of different care levels, which will change as they progress along the healthcare continuum, future research will have to follow patients. The ambition is that all levels of care and research will need to work more closely together in an altogether different, but more productive way,” boldly exclaims Svenonius.
Registries: A Treasure Trove of Data
What really marks Sweden out, however, is its ‘National Quality Registries’ containing individualized data encompassing patient problems, medical interventions, and outcomes after treatment. “Our country is sitting on a gold mine of health meta data, enjoys access to epidemiologic statistics going back more than two centuries and possesses a population that is quite open to allowing their data to be collected and extrapolated. It is very much the confluence of these factors that has endowed us with a very unique resource,” explains Karolinska Institute president, Ole Petter Ottersen.
Our country is sitting on a gold mine of health meta data
Such wellsprings of information are, quite naturally, in high demand from researchers, who comb through the intergenerational data observing patterns and linkages. Nor has this rare and unprecedented opportunity been lost on Big Pharma, almost all of which have been busy leveraging Sweden’s databases to amass formidable quantities of real world evidence.
“By harnessing the insights generated from the registries, Merck has managed to almost immediately put in place real-world data assessment for products that we have only just launched, which is very special and frankly not something that we’d be able to do in many other markets,” confides Anders Wesslau. “Obviously we are looking to the registries to replicate the scientific data accumulated in the trial, but then there are also additional benefits to be accrued such as the possibility to accelerate and deepen the process of understanding the long-term health effects of products, which is an issue frequently brought up by patients and payers alike,” he continues.
Indeed, according to Novartis’ Judith Love, the registries render Sweden an “excellent clinical trials mark-up location,” in the sense of advancing knowledge and being able to swiftly and effectively compare clinical trials readings against real-world findings.
Klaus Abel of LEO Pharma Nordics concurs. “Sweden has great patient registries that allow us to assess our product’s performance in the real world,” he asserts. “You can do that in many countries, but Sweden, in particular, allows us to better understand the social impact of our treatments… the ability to utilize real-world evidence allows us to show the value of our products and how we can get them to the right patient populations.”
“We’ve been noticing that, for patients particularly, the quality registries are useful in answering practical issues that might occur during treatment, but which may not be taken account within the normal clinical trials process. For instance, clinical trials usually do not consider pregnant women, but such outcomes have been well documented in the registries so it really deepens everyone’s understanding,” agrees Wesslau.
Guido Oelkers, global CEO of Sweden’s largest publicly traded drug maker, Swedish Orphan Biovitrum AB (SOBI) very much concurs. “In our core area of hemophilia, we are now managing to accumulate a substantial volume of real-world evidence, and this an exciting development because patients and physicians are increasingly demanding to know how treatments are impacting daily lives as opposed to merely within the confines of a clinical trial environment, and this is especially true when it comes to monitoring rare diseases,” he recounts.
Sweden offers the ideal environment to develop version 2.0 of clinical studies by churning out high-quality evidence from daily life
Certainly from a patient centricity standpoint the registries look to be a game changer. “We find them invaluable for comprehending patient and medical needs for new products, as well as for following up on treatment outcomes” reckons CSL Behring’s Martin Tenlen. “Registries help us to better understand the markets and patient needs, for example in the immunoglobulin area, allowing us to improve the way we operate and ultimately deliver up an improved patient experience.”
Moreover, advanced insights garnered from the registries can also come in handy when entering into negotiations with pricing bodies and payers. “This constitutes a tremendous resource for the entire research-based pharma community,” reflects MSD vice president for the Nordic and Baltic Countries, Jakob Tellgren. “The brute reality is that traditional clinical trials do not offer much of a competitive advantage anymore as payers are increasingly requesting additional and more stringent evidence as they try and shield overly stressed healthcare budgets. Sweden, however, offers the ideal environment to develop version 2.0 of clinical studies by churning out high-quality evidence from daily life,” he elaborates.
“Not only does this extra information helps us to design better protocols for future clinical trials and lay a solid foundation for subsequent R&D, but the sheer quality and quantity of data contained in the registers is unmatched,” concludes Boehringer Ingelheim’s former general manager Andrea Sambatti.
Many of Sweden’s over 100 quality registries were assembled using a diverse array of structures and were built at a time when the infrastructure possibilities that we can choose today simply didn’t exist, resulting, in some cases, in poor interoperability
That is not to imply, though, that the system yet works seamlessly. As the TLV’s chief pharmacist and chair of the executive board of EUnetHTA, Niklas Hedberg is quick to point out, “Many of Sweden’s over 100 quality registries were assembled using a diverse array of structures and were built at a time when the infrastructure possibilities that we can choose today simply didn’t exist, resulting, in some cases, in poor interoperability.” In a bid to rectify this, the Swedish Research Council has been developing a metadata Register Utilizer Tool (RUT) with a view to facilitating access and sharing.
“This is undoubtedly a fantastic resource base, but the outstanding challenge is that the different systems do not interact and talk with one another: one region’s data vault does not necessarily match with the others, which is much more fragmented than it needs to be for a country of our size. It would be best if we could amalgamate the data into a single harmonized system and fortunately, there ongoing work in that direction which is sure to significantly enrich the value of the insights that we can generate,” opines LEO Pharma’s Anders Ekblom.
Sweden, like many mature western markets, has begun to rethink healthcare provision by decentralizing the locus of care and shifting emphasis over to primary care, such as the general practitioners and community clinics
Still, some obvious variances in the quality of different data sets remain, owing largely to historical legacy and the evolving dynamics of healthcare provision. “Current national registers primarily include data from the secondary care sector because hospitals were the main care institutions when these registers were first created. However, Sweden, like many mature western markets, has begun to rethink healthcare provision by decentralizing the locus of care and shifting emphasis over to primary care, such as the general practitioners and community clinics, so that they are better resourced and can act as the first contact point with the health sector. However the quality of data is considerably poorer for primary care and almost non-existent in the up and coming home care setting,” explains Olivia Wigzell, director general of the National Board of Health.
“At the moment, we have to work in a different manner and use the prescription of drugs as a proxy for primary care data, linking the pharmaceuticals delivered at the pharmacies to primary care. The government now wants to implement a primary care reform, which includes national collection of registry data from the primary care sector,” she adds.
Unsurprisingly Sweden’s iconic registries are embedded within an all round highly developed digital architecture and the country is gaining a well-earned reputation for embracing, and even shaping, the digital revolution that is radically disrupting life science markets around the globe. “Sweden is already considered among the most tech-savvy nations in the world; not only are our greatly skilled software engineers proactively thinking outside the box to develop practical healthcare apps, but our citizens are demonstrating immense enthusiasm in adopting and applying them,” muses Göran Ando.
Indeed, in the first half of last year, health tech attracted a full 10 percent of all Swedish tech venture capital investment according to Nordic venture capital investor Industrifonden and naturally international drug makers are keen to tap into this burgeoning digital health startup ecosystem. Pfizer, for example, has identified Stockholm’s dynamic startup scene as an ideal location to base one of its digital Healthcare Hubs. “The goal is to identify, interact and support the startups that can provide solutions including better diagnostics, monitoring, treatment follow-up and patient support tools. We are sensitive to the fact that these kinds of startups are developing the technologies which will shape the healthcare of the future, so are very excited and keen to be actively participating in this revolution,” reasons Malin Parkler. “One fascinating initiative we are involved in is the Dream Catcher app, an innovative digital tool for young people with rheumatic disease that inspires them to achieve their dreams and not be limited by their condition.”
I personally identify huge potential for Boehringer Ingelheim to start collaborating with and supporting these types of technologies
Meanwhile, BI-X, an independent subsidiary of Boehringer Ingelheim dedicated to fostering breakthrough digital solutions in healthcare from idea to pilot and acting as an engine for digital transformation in data science, agile software development and user experience design, views Sweden as a fertile environment for new ideas creation and prototypes. “When I last met with the BI X team, I highlighted local apps like MinDoktor and video-based healthcare provider, Kry. In Sweden, patients can have a discussion with a doctor through these apps and it is incredibly convenient. Furthermore, they cut down on the need to physically go into a hospital where you may be at risk of contracting an infection from other patients. You can simply wait for the next available doctor and have a video call with him or her. I personally identify huge potential for Boehringer Ingelheim to start collaborating with and supporting these types of technologies,” concedes Andrea Sambatti.
Iddo Leshem of BMS has very much reached the same conclusions. “A growing number of patients in Sweden are becoming noticeably more informed and involved in decisions about their health and treatment plans. These patients tend to be connected, tech literate, digitally astute and have far better access to information than in the past. This means in Sweden, we possess a unrivalled opportunity to think address digitalization and define radical new e-health approaches,” he says, pointing to the roll out of an app designed for supporting immuno-oncology patients outside the clinic and developed in conjunction with local physicians and a digital health outfit. “Via this channel, patients are able to report critical information such as side effects and the information is aggregated and made available to physicians,” he affirms.
Digitalization is very high on our agenda and consequently we’ve been working hard to integrate and exploit artificial intelligence, machine learning and connectivity with a view to growing our way up by incorporating these tools
Nor is all the activity about MNC’s interactions with e-health star-ups. Indigenous companies, especially in the medtech segment, have also proven quick out of the blocks to adopt state-of-the-art digital solutions. Arjo is a case in point. “Digitalization is very high on our agenda and consequently we’ve been working hard to integrate and exploit artificial intelligence, machine learning and connectivity with a view to growing our way up by incorporating these tools. For example, one of our current solutions is a simple tracking system for patient handling equipment that saves a significant amount of time for nurses,” reveals global CEO, Joacim Lindoff. “So far, the main thrust of our emphasis has been on digital solutions that aim to prevent things from happening, as opposed to the ‘prediction’ business, which is on shaky regulatory ground… Next Step Dynamics is an example of an innovative startup that has shifted the paradigm around being able to anticipate an increase in a patient falling, which gives caregivers an opportunity to step in before an accident of that nature occurs.”
Another iconic local player, Getinge, has also been broadening its horizons. “I’m proud to be able to say that our largest R&D investment at the moment is our collaboration with Verb Surgical for robotics, artificial intelligence and imaging,” details Mattias Perjos, global CEO. “Furthermore, every new piece of equipment sold by our company now features built-in connectivity as a matter of course.”
Right now we still have much to learn from some of our peers when it comes to fine tuning the infrastructure and standards for health data
A multitude of state-driven, top down initiatives are also complementing the proliferation of health tech startups being spawned at the grass roots level. Not only does the country already boast a wide range of digital health services encompassing e-prescriptions, personal online health accounts, electronic birth registrations, digital doctor appointments via video chat, and online booking systems, but the authorities have also committed to the 2025 objective of becoming “the world leader and trailblazer in harnessing the opportunities offered by digitization and e-health” to make it easier for people to achieve good and equal health and welfare.
“Right now we still have much to learn from some of our peers when it comes to fine tuning the infrastructure and standards for health data. Finland, for instance, has already introduced new legislation for secondary use of health data which represents an important step forward for healthcare, academia and industry to be able to utilize data, while Estonia is leading the way for securely sharing medical records via deployment of block chain,” candidly admits Jenni Nordborg, director and national coordinator at the Office of Life Science.
Again the issues that Sweden now finds itself grappling with are primarily the product of history and the fact that the country was a first mover in going digital in the life science space. “Let’s not forget that a decade ago we were already fully digitalized with the systems being rolled out on a regional basis so it’s hardly surprising that we are not quite up to date with today’s international standards… thankfully, rectifying this does not entail replacing the current infrastructure rather joining up the dots to enable federation of data in a secure way,” rationalizes Nordborg.
A Paragon for Regulatory Science
When it comes to pioneering regulatory science, Sweden can equally be held up as a role model and pin-up for others to aspire to. “The Medical Products Agency (MPA) has been extremely progressive in almost every aspect. The EMA farms out its reviews to a rapporteur and co-rapporteur, and Sweden, alongside the UK, has been the most prolific for these activities,” surmises Göran Ando.
“Moreover at a local level, the MPA is regarded as a good partner in the sense that, although they have a reputation of being stringent and tough, their door is always open, they are supportive, and share their views and key information effortlessly all of which is tremendously important for life science SMEs. At the same time, the Dental and Pharmaceutical Benefits Agency (TLV) demonstrates a superb balance between prioritizing essential drugs at the right compromise for the companies and pushing these through onto the market quickly and efficiently,” he enthuses.
Such a view certainly seems to be reflected by many industry insiders. “Even though Sweden can be described as a regulated market, it is in many respects progressive and innovation-friendly. There is a clear willingness and openness from authorities to work together with the industry,” acknowledges Sanofi’s Anna-Kaija Grönblad.
“I would definitely say one of our strong points as a regulatory apparatus is the informal and open landscape for discussions and exchange of information with industry. This does not mean that we must always follow what everyone else says, but it does mean that we act as a genuine partner, are always open minded and not afraid to embrace change,” insists the TLV’s Niklas Hedberg.
If there is one particular regulatory area where Sweden has already become something of a poster child and reference point, it is perhaps for its willingness to embrace value-based care. “The strength of Sweden’s regulatory process lies in its transparent value-based system. Historically, this system has made it possible to predict with a high degree of certainty whether a product will be reimbursed at the national level by the TLV. The process is clear, the decisions are relatively fast and, in our case, all of our diabetes products are approved and reimbursed,” ruminates Novo Nordisk’s Niels Abel Bonde.
Value-based care can be considered one of Sweden’s standout features
“The TLV has already been handed a government mandate to develop a new value-added pricing model of biopharmaceutical drugs based on real-world outcomes as compared to the results of clinical trials,” confirms Olivia Wigzell. Indeed, the agency has already commenced a dedicated pilot project on real-world data analysis in conjunction with heavyweight industry stakeholders – notably AstraZeneca and Sanofi.
“The Swedish model has already served as an example for other European countries, because we have the oldest health technology assessment body in the world and a value-based pricing system since 2002. Our reimbursement system has been very successful from a societal perspective, as it uses a holistic approach of how a treatment is contributing to the eventual overall outcome. While other countries may have a short-term budget plan, our system provides longevity in thinking about innovation,” argues Merck’s Anders Wesslau.
“Value-based care can be considered one of Sweden’s standout features and a recent study we put together with the Economist Intelligence Unit actually validates that assertion,” agrees Vatroslav Mateljic, general manager of Takeda’s local affiliate. “Having crossed the Rubicon from volume to value and having established a functional supporting infrastructure – encompassing registries, bio-banks and integrated care solutions – to be able to properly adjudicate value, Sweden has become strategically important and that is precisely why we have been investing resources to build a center of excellence. Our intention is very much to upscale the findings and solutions from this marketplace to other countries, so that our entire global operations can benefit from our work,” he stresses.
Assuming a role of leadership, however, necessitates continual improvement and work. “It is imperative that we don’t rest upon our laurels and stand still,” cautions MPA director, Catarina Andersson Forsmann. “As a regulator, we face many challenges with the onset of breakthrough technologies and treatments. Today, we encounter large complex molecules that address a single patient, such as cell and gene therapies and we have to continually invest in keeping abreast of the science and in reconfiguring our methodologies so as to be able to properly integrate these latest-generation approaches into our evaluation process.”
The current system is not broken, but we are shifting in a different direction which naturally requires an alternative and bespoke regulatory and pricing pathway
“For classic medicines including chemically synthesized pharmaceuticals, the Swedish regulatory framework is most definitely fit-for-purpose, but to maintain its positive ranking at a juncture where the next epoch of treatments constitute biologics that are personalized precision therapies that work within the immune system of each individual patient so not pharmaceuticals per se, we need to continue to innovate,” insists Novartis’ Judith Love.
“The current system is not broken, but we are shifting in a different direction which naturally requires an alternative and bespoke regulatory and pricing pathway. Neither the industry nor the authorities yet know how this new framework should look like, hence the need to come together and experiment with innovative payment models that facilitate patient access and set up outcome-based mechanisms… I am nonetheless very confident that Sweden is the appropriate venue to be pioneering this, thanks to the sheer openness, collaboration and enlightenment that we encounter in this country, she acknowledges.
“The mature markets of Western Europe, in general, are a tough place to bring products to market and among European member states, the UK and Sweden are the most challenging in terms of health technology assessment,” ventures Otsuka’s Pontus Billstam. “However, in many ways, they offer a representation of how the future will look and are rightly deployed as benchmarks by other European nations for everything from pricing to reimbursement decisions.”
All of this confers added credence to a widespread perception of the Swedish market as a test-lab and preferred venue of choice for experimenting with pilot initiatives. “Certainly for Otsuka, both the UK and Sweden function as early launch markets, which for me is very exciting. And given this status as a small, challenging, but dynamic and forward-looking marketplace, there is a clear logic as to why so many of the MNCs use Sweden as a learning ground for new and upcoming country managers,” shrewdly notes Billstam.
“I firmly believe that Sweden presents a conducive and receptive ecosystem for getting pilot projects off the ground at pace, and this ability for local affiliates to launch new products very early on vis-à-vis other markets renders the country strategically relevant as a forerunner,” details Takeda’s Vatroslav Mateljic. “Often our activities here constitute the first step in the process of unveiling a new product before being able to scale up to cover other developed markets and to gain the requisite intelligence to consider introducing to emerging economies.
Given this status as a small, challenging, but dynamic and forward-looking marketplace, there is a clear logic as to why so many of the MNCs use Sweden as a learning ground for new and upcoming country manager
Ferring’s Peter Marcusson reasons Sweden’s appeal as a living lab thusly. “I think it comes down to the constellation of a variety of factors including a bold and enlightened regulatory apparatus, a sophisticated healthcare ecosystem, a well-integrated academia and a cultural propensity to be an early adopter of technologies… For many pharma companies this market has become a haven for experimenting with and trying out the next generation of diagnostics and treatment methods. Exciting things are happening out here as can be seen from ongoing discussions with respected Swedish clinical centers such as Karolinska University Hospital, Sahlgrenska University Hospital and Skåne University Hospital, all of which have expressed great interesting participating in clinical studies for these new treatment paradigms.”
Moreover the Swedish affiliates of many MNCs can boast having been the first to unveil first-of-a-kind innovations. Novo Nordisk counts as one such example. “I am very proud to say that our office was the first to introduce our durable smart insulin pen, which automatically records when and how much insulin was injected and is equipped with near field communications capabilities to move the data off the pen and to another device,” recalls Niels Abel Bonde. “In the Swedish pilot, the pens were actually downloaded in the healthcare provider’s office using a kiosk with a view to improving the conversation between diabetes patients and the healthcare provider as well as so as to be able to combine insulin and glucose data for greater insights.”
Bonde’s focus now is firmly on becoming one of the earliest affiliates to manage to bring to market the first ever orally available GLP-1, which is close to receiving approval. “When this happens it is going to be a watershed moment because injections as a delivery mechanism remain a significant barrier for some patients and the ability to launch a tablet formulation should constitute a big step forwards for ensuring greater levels of compliance… right now, the local authorities have been taking the improvement of diabetes care very seriously which has been fueling the introduction and use of innovative diabetes treatments. I am therefore pretty optimistic my affiliate can be at the vanguard once again.”
The key [to a successful product launch in Sweden] is to start early and engage directly with stakeholders while simultaneously fully utilizing the real-world evidence available in the country
It shouldn’t be forgotten, however, that a precondition to being able to launch early is a willingness to enter into the spirit of collaboration and inclusiveness so deeply ingrained in Scandinavian culture and to be proactive in mobilizing the participation of different stakeholders. AstraZeneca’s Michelle Werner, interestingly, offers some very clear advice for newcomers to the market on how to maximize their chances of a strong launch. “The key is to start early and engage directly with stakeholders while simultaneously fully utilizing the real-world evidence available in the country. This represents a very different approach to formalistic product launches in the United States. In Sweden, there is a big emphasis on share of voice and thus the launch speed tends to be determined much more by the pace of the internal organization. The priority therein lies in collaboration with government, key external stakeholders and of course patients and physicians.”
Finding the Groove
Host to the internationally renowned medical university Karolinska Institute, the (soon-to-be) world’s most powerful neutron source, and MAX IV, the globe’s foremost synchrotron radiation source, Sweden clearly continues to cement its reputation as a trailblazing life science nation. The country will nonetheless have a tall task on its hands if it is to retain its competitive edge in a era in which medicinal science is being thoroughly shaken up by all manner of disruptive forces: from genomics and personalized precision therapies on the inside to artificial intelligence, algorithmic methodologies and blockchain on the outside. Only time will tell whether the country can hold its nerve, find its groove and remain ahead of the game.
Sweden is auspiciously positioned for the life science paradigm of tomorrow
Nonetheless, in the eyes of many, the signs augur well. “Sweden is auspiciously positioned for the life science paradigm of tomorrow in that we have at our fingertips a collection of rich data sets, a small cohesive population and an intelligent approach… collectively we seem to be advancing the infrastructure and the data science perspective to unlock brave new opportunities,” remarks Roche’s Amy Van Buskirk. “Sweden will never be the largest market for this sort of thing, but there’s absolutely no reason why it can’t be the smartest,” concludes Anders Blanck.
* This Long Read was first published as part of the Healthcare & Life Sciences Review Sweden report in December 2019.