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Sweden favors mandatory rules that would require companies to apply for drug pricing and reimbursement in any member state that requests it. Currently, a minority of EU countries support such an approach, but Pharmaceutical Packaging Negotiation continue.
The Belgian Presidency adopted a proposal from the EU Parliament’s final report ahead of the June meeting of the Employment, Social Policy, Health and Consumer Affairs Committee (EPSCO).
The “fourth option” provides that pharmaceutical companies are obliged to seek pricing and reimbursement (P&R) for medicines if any member state so requests.
Sweden and a few member states He expressed supportHowever, most EU countries still tend to implement a regulatory incentive system for medicines.
However, an unnamed source in the Swedish Cabinet Office told Euractiv that the design is far from complete.
“This legislative policy is under discussion and will continue for a long time. Currently, there is no consensus on how to design this policy,” the expert said.
RDP and Incentives
The EU Council negotiations on the proposed new pharmaceutical legislation focused on the EU’s Regulatory Data Protection Period (RDP) and a new incentive system for the pharmaceutical industry.
Currently, inequalities in the availability of medicines across the EU are often caused by a complex range of factors, such as National Postcode Lottery – Sweden is no exception.
While a company can launch its medicines in any country depending on its marketing strategy, various national procedures for launching medical products also play a role.
Today’s “8+2+1 years” RDP model is under review, with the European Commission proposing a shorter period, while various measures (such as selling medicines in all member states) could provide companies with additional years.
Sweden’s position
Sweden’s position is to retain the “8+2+1” model. Moreover, for Stockholm, the main advantage of the proposed legislation is that it no longer links the RDP to the 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 data already submitted during the application process,” Acko Ankarberg Johansson, Sweden’s Christian Democratic Party health minister, told the Swedish parliament’s European Committee on June 14.
Meeting shorthandThe policy decision published in mid-July also showed that the Swedish Minister of Health’s push for this route had broad support, as the Social Democratic Party publicly announced its support for the fourth option on June 14 and no other party expressed reservations.
Surprisingly, Acko Ankarberg Johansson did not consult the country’s pricing body, the Dental and Pharmaceutical Benefits Agency (TLV), before the EPSCO meeting in June.
Johan Pontén, the agency’s international coordinator, told Euractiv he did not know the details but did not want to comment on the proposal.
Checks and balances needed
Ana Nordberg, associate professor of health law at Lund University’s School of Law in southern Sweden, told Euractiv that she is positive about the EU trying to address drug supply and shortages through law. However, the negotiations are at an early stage and checks and balances are needed.
“We have to remember that this only means an obligation to submit an application and negotiate with national authorities. But I am sure that it could be a step towards increasing access to medicines for Europeans,” she said.
Nordberg said that currently, only some designated orphan drugs or advanced medical therapies that have a locally relevant patient population in a member state are exempt from this obligation.
Unanswered questions
But at the same time, many details remain unclear.
“For example, if a pharmaceutical company does not comply, what are the sanctions? Are they decided by the member states themselves or centrally by the European Commission?“ Ana Nordberg wondered.
She also said the European Parliament’s report gave the European Commission wide leeway to decide on the details of the delegated act.
The Commission will also need to establish a mediation mechanism to resolve situations where Member States and companies disagree on issues related to the R&P application process.
“However, there is currently little information available on how the mechanism will work,” says Ana Nordberg, stressing that the R&P process is a national competence.
Patient and industry response
Lif, the Swedish association of research-based pharmaceutical companies, is neutral on the fourth alternative for now, Jenni Nordborg, the association’s director of international relations, told Euractiv.
“We need to study the proposal and think about its consequences, but we think it is positive in terms of replacing the link between the RDP and incentives with other working methods in order to increase the availability of (medicines) for all Europeans as quickly as possible,” she said.
Nordborg also wants the directive to be as clear as possible and to be developed in dialogue with industry, taking into account differences in national healthcare systems.
Anders Åkesson, secretary general of the Swedish Heart and Lung Association, which has about 35,000 patients as members, is in favor of forcing companies to apply for P&R.
“This would be a good model. However, the EU and the Swedish government would also have to ensure that life science companies have good opportunities to conduct research in Europe and Sweden,” he told Euractiv.
Åkesson believes that introducing new drugs in Sweden needs to be simpler and the national decision-making process needs to be more transparent.
He is also concerned that innovative medicines for patients with heart and lung disease are not being introduced in Sweden because of their high prices.
That’s what happened with a new drug recently launched in Sweden for patients with an enlarged heart, or hypertrophic cardiomyopathy.
(Written by Monica Kleja; Edited by Vasiliki Angouridi, Brian Maguire | Euractiv Advocacy Lab)
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