Health committee  We have a relatively high expenditure on health care costs in Sweden, but we also have a good ratio between the quality of the medical results and the resources we put in. When it comes to the pharmaceutical part of the health care spending, it's average on a European level. When it comes to prices, we have slightly over-average prices within the European Union.

Health committee  I would say that the efficient system for generic competition is an important basis. It creates headroom for innovation, and that leaves us in a good place when it comes to our relatively high, I would say, willingness to pay for new pharmaceuticals that bring added value. Having the value-based approach and trying to develop our decisions on our follow-ups in such a way as to pay for performance or pay for results and link that to our developed real world data work has also, I think, helped.

Health committee  For the outpatients pharmaceutical benefits scheme?

Health committee  That would be about 25 billion Swedish krona per year, which I think is about 2.5 billion euro per year.

Health committee  It is 10 million.

Health committee  It has been so for quite some time. My agency was formed in 2002. Even before that, we had a universal pharmacare program in Sweden, but not with this kind of elaborated pricing and reimbursement decisions. It was more of an automatic reimbursement when new products came to market.

Health committee  The regulatory work in Europe is harmonized, so it's the same for all the EU countries. There is a European agency, the EMA, that approves the drugs. That is a joint regulation for all countries.

Health committee  Of course. When the product has come to market, it is the TLV that decides the price and the reimbursement within the pharmaceutical benefits scheme. If it's an in-patient drug, it is the 21 county councils that have a tender procedure to decide on the price and usage of in-patient drugs.

Health committee  Yes, that's how it works.

Health committee  In Sweden, we have the value-based approach, which means that the TLV uses health technology assessment as an important tool on which to base our decisions. When we assess a new drug, we take into account both therapeutic effects and, of course, the cost of using this drug in clinical practice.

Health committee  The follow-up in early phases and in small patient groups in clinical practice, within these real-world data pilots that we have launched this year, is absolutely key.

Health committee  Thank you very much, Mr. Chairman. As you said, my name is Sofia Wallström. I'm the director general of the Swedish Dental and Pharmaceutical Benefits Agency, the TLV. I want to thank you for the invitation to address the committee today, and I hope that our experiences can be beneficial to your work.