Dr. Olsson Birgersson, Medical Director of Roche Sweden argues the importance of developing clinical research within Sweden, why the Swedish healthcare system is no longer the forerunner in Europe that it once was, and Roche’s intentions of further strengthening personalized healthcare products while adapting to the needs of their costumers.

Sweden has a much-praised value-based pricing system. How well would you say it works finding the balance between containing cost and serving patient interest?

I have been lucky enough to witness how the Swedish reimbursement was shaped. It was in 2002 that the current set-up was formed. They pushed very hard from the start for value-based discussions and evaluations, wanting a thorough health economy dossier and analysis. They have done that in a good and collaborative way. We have had the opportunity to have an open dialog with the reimbursement body, and it has also been looked upon, at least by other European countries, as a good model.

Coming from a value-based perspective and discussion, we have moved into a mix today with a lot of focus on the budget constraints. The budget constraints that we have seen in many countries are also striking Sweden of course.

We have other kinds of discussions and collaborations, not with one reimbursement body but with several. Sweden is a country with a rather big area, but with quite a small population. Despite the fact that the population is small, Sweden is divided into 20 self-governing county councils that are responsible for healthcare and they have the right to impose local taxes. This means that we also have a lot of local decision makers that assess and evaluate if they want to accept new treatment options or not, both on a political and administrative level, as well as on clinical level with heads of clinics.

How challenging is it to provide the health-economic data to ensure reimbursement in this system?

Over the past years we have seen an increase in demand for health economic data and evaluation. That did not come as a surprise to the industry. I have worked in the industry for eleven years and the discussion started already back then, and we are still discussing it.

We discussed a decade ago that we needed to build a lot of utilities and values into our clinical development program to be able to assess the cost-effectiveness part. We are doing better today than before, but I think we can improve further.

Although the number of clinical trials in Sweden has been dropping, quality and speed are still praised, and some companies actually increase the number of trials they conduct here. How would you rate attractiveness of Sweden as a destination for clinical trials?

The decline in the number of clinical trials in Sweden is being discussed extensively by different stakeholders in an effort to understand the reason.

When I was a researcher working in the clinics it was natural to bring clinical studies into the healthcare system, because that was part of our task working at a University hospital. You were expected to educate people, do clinical research and of course take care of sick people.

Today it feels as if you are disturbing the health production if you come with proposals for clinical studies. The focus is solely on healthcare, and the clinics are measured on how they provide healthcare in due time and in what numbers, and not at all on how they perform with regards to development and research.

Doing clinical research is not rewarding for someone working at a hospital today. It does not boost his career, rather the opposite. Colleagues that focus on health production move on in their career, while those that do part-time research are left behind.

Is this a particularly Swedish problem?

Sweden is competing with other countries today whereas we used to feel that we were bringing the highest quality in clinical trials. We do have a very modern and accurate health system with our famous identity number that every citizen gets from the moment of birth, and many highly qualitative registries are in place as well as a set-up for biobanks, which is excellent. All these things should make us very attractive.

But countries outside Western Europe nowadays offer more or less the same quality and the same tools for investigating patients. They are delivering and have a positive attitude towards clinical trials. Western Europe faces stiff competition.

Clinical research is not so highly valued today in a country like Sweden as it was say, 20 years ago. We need to put it on the agenda again, and the government has taken a lot of steps in that direction to try to find initiatives that can stimulate and motivate the healthcare system and the heads of the clinics in becoming more positive to clinical research again.

I am part of the committee for research and development, within the Swedish Pharma association (LIF). We follow closely how clinical research is developing and we try to come up with good ideas and initiatives on how to make clinical research more attractive in the clinics. One idea is to stimulate clinics to have more positions for part-time research.

Could you go into more detail about Roche’s research activities in Sweden?

When I joined Roche 1.5 years ago I was very impressed when I looked into the clinical operation unit and the number of clinical trials that we are conducting in Sweden. We have for the moment 80 ongoing studies, and 58 of these Roche AB is running ourselves. The other 22 are run by CROs. We are working in all of Roche’s different therapeutic areas and in different stages – from quite early development to observation and follow-up studies.

Is Sweden also attractive for early phase studies?

We, at Roche AB, do not have phase I studies ongoing at the moment in Sweden, but we do have phase II studies. Although we can see a decrease in total clinical research in Sweden, I do not feel that from a Roche perspective we have seen a decrease in the number of trials conducted and I do not see that Roche is being pushed out from the hospitals.

I would say that the clinical operation unit here has been very successful in partnering with the healthcare system. We are seen as a preferred partner for doing research in Sweden.

The market is clearly shifting away from ‘one size fits all’ products. How appreciative is Sweden of Roche’s personalized healthcare products?

We are working closely with our Roche Diagnostic sister company here in Sweden, and we are stepping up our collaboration. Every time we launch a new product, we try to see how we can optimally use the competences in both parts of the business.

In Sweden Roche Diagnostics and Roche Pharmaceuticals are separate companies, but when we meet our customers, Roche is Roche.

In earlier stages when we develop a new drug, we are doing research in parallel on markers to identify the right patient for a specific drug, but also to be able to follow the success of the treatment. This gives us an edge since we have the knowledge and experience from the start, under one roof. Other companies have to buy different diagnostic tools or partner with a diagnostics company. Personalized healthcare is something we in Roche want to strengthen even further.

We find that Sweden is a frontrunner in developing new models of market access, for instance through developing the role of sales reps into key account managers, with a broader role identifying barriers in the identification, diagnosis of patients and solutions to bring better adherence. How has this development on the role of the medical affairs department as a support function? Is Sweden a frontrunner there too?

The whole environment started to change around ten years ago. We started working with a new ethical code to regulate how we could really collaborate in a transparent way. The rules that were set up made it difficult for the pharmaceutical companies to approach the healthcare system in the way we were used to—for example, meetings and educational seminars were restricted. Of course the pharmaceutical industry needed to adapt, so sales reps as you see them today still in Italy or France doing 15 short sales calls every day are no longer permitted in Sweden. We now have meetings with a clinic or with a group of people if it is pre-arranged and the agenda is properly set. We have seen an increased demand for more scientific discussions and the need for medical competence in the industry are growing. The collaborative projects we see today have a more medical context than before.

Is it fair to say that the medical department is taking back its rightful place as the central department?

The medical affairs department is of course a very crucial part of any pharmaceutical company, but I truly believe that sales departments and field forces also are essential parts of what we do as a company. There is also another important department that has grown and that is the market access aspect of our business. One of their main issues is how to get a good and trustful dialog with all the new stakeholders that are having a say in the more and more complicated healthcare and pharma business landscape.

You have come in then at an interesting time when shifts in the company structure allowed you to reshape the role of the medical department. What are your key ambitions for the medical department and speaking on a broader level for Roche in Sweden in the coming three to five years?

We have continuously tried to adapt to the needs of our customers, and this is something that we need to strengthen even further. We need to have an ongoing dialog with our customers, not just by providing new, efficient and safe drugs but also by contributing with new value concepts that will support and help them. After all we do share a common interest in getting the best treatment to the patient as soon as possible. But the healthcare system today is in a situation that forces everyone to prioritize. We need to try and find a way together to use the resources in the best way.

Roche aims to optimally use our competences and tools, from both Diagnostics and Pharma to be facilitators and use our knowledge and our networks, not just in our country but also internationally.

If we continue to be honest and transparent in what we are providing, I am sure we will see even more collaborative projects that could really fuel the healthcare system.