Sweden favours compulsory application for medicines reimbursement in any member state requesting it [Advocacy Lab Content]

Sweden favours creating a compulsory rule for companies to apply for medicines pricing and reimbursement in any member state requesting it. A minority of EU countries currently support the approach, though pharma package negotiations continue.

The Belgian presidency took up a proposal from the EU parliament’s final report ahead of the Employment, Social Policy, Health and Consumer Affairs Council’s (EPSCO) June meeting.

The ‘fourth alternative’ introduced a legislative obligation for pharmaceutical companies to seek pricing and reimbursement (P&R) for medicines if any member state requests it.

Sweden and a small group of member states expressed support, while most EU countries  still favour a modulated incentive system for pharmaceuticals.

However, a source in the Swedish cabinet office, speaking on condition of anonymity, told Euractiv that the design is far from finalised.

“This legislative policy is under discussion and will be so for a long time to come. At the moment, there is no agreement on how this policy should be designed,” the expert said. 

RDP and incentives

The focus is on the EU’s regulatory data protection period (RDP) and a new incentive system for the pharmaceutical industry in the Council’s negotiations concerning the proposed new pharma legislation.

Current inequalities in the availability of medicines across the Union are often due to a combination of complex factors resembling a national postcode lottery – Sweden is no exception.

While companies can launch their medicines in any country based on their marketing strategy, various national procedures for introducing a medical product also play a role.

Today’s “8+2+1 years” RDP model is under review, with the EU Commission proposing a reduced period, while various measures, such as selling medicines in all member states, could give companies additional years.

Sweden’s stance

The Swedish position is to keep the “8+2+1” model. Moreover, for Stockholm, the main advantage of the proposed legislation is moving away from linking RDP to an incentive system.

“The government believes that the Commission’s proposal to make data protection conditional on pharmaceutical companies taking certain measures would create too much unpredictability, both for research-based pharmaceutical companies and for generic companies that rely on already submitted data in the application process,” Acko Ankarberg Johansson, the Sweden’s Christian Democrat health minister, told the Swedish Parliament’s EU committee on 14 June.

Shorthand notes from the meeting, made public in mid-July, also show that the Swedish health minister has broad support for pushing this line, as the Social Democrats openly declared their support for the fourth alternative on 14 June, and no other party expressed reservations.

Surprisingly, Acko Ankarberg Johansson did not consult the country’s price-setting agency, the Dental and Pharmaceutical Benefits Agency (TLV), before the June EPSCO meeting.

Without knowing the details, Johan Pontén, international coordinator at the agency, told Euractiv that he did not want to comment on the proposal.

Need for checks and balances

Ana Nordberg, an Associate professor at the Department of Law, focusing on Health Law at the University of Lund in southern Sweden, told Euractiv that she is positive that the EU is trying to solve its problems of drug availability and shortage by law. However, the negotiations are at an early stage and there is a need for checks and balances.

“One must remember that it only means an obligation to submit an application and enter into negotiations with national authorities. But I am positive that it may be a step in the direction to increase Europeans availability to drugs,” she said.

Currently, only some designated orphan medicinal products or advanced medicinal therapies with localized relevant patient populations in a member state are exempt from the obligation, according to Nordberg.

Unanswered questions

At the same time, many details are still unclear.

“What would the sanctions be, for example, if a pharmaceutical company does not follow the rules? Would sanctions be decided locally by a member state, or centralised, by the EU Commission?“ Ana Nordberg wondered.

She also said that the EU Commission has been given a lot of leeway in the EU Parliament’s report to decide on details in delegated acts.

The Commission is also required to set up a conciliation mechanism for cases where a member state and a company disagree on issues relating to the process of R&P applications.

“However, there is almost no information yet on how the mechanism would work,” Ana Nordberg said, highlighting that the R&P process is a national competence.

Patients and industry reactions

The Swedish association of research-based pharmaceutical companies association, Lif, is neutral on the fourth alternative for the time being, Jenni Nordborg, its Director of International relations, told Euractiv.

“We need to study the proposal and look at its consequences, but we consider it to be positive as far as replacing the link between RDP and incentives with other working methods in order to increase the availability [of medicines] for all Europeans as soon as possible,” she said.

Nordborg also wanted the directive to be as clear as possible and to be developed in dialogue with the industry, taking into account national differences in healthcare systems.

Anders Åkesson, secretary general of the Swedish Heart and Lung Association, which has around 35,000 patients as members, is in favour of companies being obliged to apply for P&R.

“It will be a good model. However, the EU and the Swedish government must also ensure that life science companies have good opportunities to do research in Europe and Sweden,” he told Euractiv.

According to Åkesson, introducing new medicines in Sweden needs to be easier and national procedures need to be more transparent about how decisions are made.

He is also concerned that innovative drugs for people with heart and lung diseases are not introduced in Sweden because of high prices.

This is what happened recently with a new drug for people with an enlarged heart, or hypertrophic cardiomyopathy, in Sweden.

[By Monica Kleja, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]

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