Stockholm looks for perfect balance in EU pharma package

Sweden’s government wants to strike a balance between ensuring access to medicines for all patients and creating the best conditions for the research and development of new drugs, according to statements made during a recent public hearing.

“We need rules that can help ensure a robust supply of medicines throughout the EU […] and EU citizens must be confident that they will have access to drugs when they need them”, the Swedish health minister Acko Ankarberg Johansson, Christian Democrat, said last week at a public hearing on the new EU pharma regulation, organised by the Parliament’s Social Affairs Committee.

For the first time, stakeholders were invited to the Swedish parliament, the Riksdag, to discuss how Sweden should respond to the pharmaceutical reforms proposed by the EU Commission earlier this year.

Ankarberg Johansson began her speech by saying Sweden was in favour of modernising the rules, which are some 20 years old. This is to improve patient access to medicines, strengthen the competitiveness of the European pharmaceutical industry, improve the environmental sustainability of medicines, and fight antimicrobial resistance.

The government, she said, supports the “Commission’s ambition to achieve equal access to drugs across all of Europe”, and she highlighted the need to enforce access to new orphan therapies. At present, 95% of rare diseases, which often affect children, have no treatment.

During the three-hour-long public hearing, huge discrepancies in the views of the Swedish health stakeholders were brought to light.

The two sides of the conversation

On one hand, the Swedish Association of research-based pharmaceutical companies, Lif, is fighting not to “weaken” the current data protection of drugs.

Its CEO, Johan Färnstrand, argued that the proposed new rules – which reduce the basic data protection period for medicines from eight to six years ´to allow faster market accesses for generics and biosimilars – “would hamper research and innovation and undermine the European competitiveness”, and affect “the many small companies in the Swedish Life science sector.”

The Commission proposes two extra years of protection for any company that markets a medicine in all EU member states within two years after market approval in the EU. But this, Färnstrand said, would, in principle, be impossible to achieve for minor and major companies because of national hurdles.

At the same time, Maja Neiman, “science director” of the association Bio Sweden, which counts more than 300 small health start-ups as its members, stressed a need for more “predictable rules”, saying those are especially important for innovative companies of smaller size.

On the other hand, the Swedish Association of Local Authorities and Regions wants to see changes to the reform package to reduce the costs of medicines in the future so that regions can afford new therapies.

For example, they are hesitant about whether “carrots” to companies which launch medicines across the EU in the stipulated time are a good idea, according to their representative Maria Landgren.

Both the Swedish price-setting authority, the Dental and Pharmaceutical Benefits Agency and the regions’ association are also calling for drugmakers to be required to provide more scientific evidence of the benefits of a new drug when applying for market approval in the EU.

The companies, they stated, should, for example, submit results from clinical trials where the effect of a new product is compared with existing treatments.

The hearing also revealed that vouchers will be a point of discussion going forward.  The Swedish Public Health Authority warns of risks and uses a Swedish model with supply guarantees instead. The EU voucher aims to give extra data protection for companies that invent new antibiotics, which Europe greatly needs.

‘Balance’ is the word for Stockholm

For the Swedish government, it boils down to finding a balance.

“A major sticking point in the new regulatory framework is how we can ensure a future-proof regulatory framework that contains the right balance of medicines for all patients and the best conditions for the development of innovation of new medicines”, Acko Ankarberg Johansson concluded in her speech.

The pharmaceutical package was translated into all EU languages in September, giving the green light for negotiation in the Council and the EU Parliament. So far, the Spanish EU presidency has held only a few Council meetings, according to the minister.

She told Euractiv that she hopes the incoming Belgian presidency will push the reform package forward next year. But there seems to be no timetable for how long the process could take.

As with other EU issues, the Swedish government must get its views across in the Riksdag. In the Social Affairs Committee and on important occasions in the EU committee.

“First of all, we have given the health minister a broad mandate to negotiate the legislative package in the Council. She and her colleagues would have to come back to us along the way to discuss further details and get support for any policy ideas”, Fredrik Lundh Sammeli, vice president of the Social Affairs Committee and the Social Democrats’s spokesperson on health issues, told Euractiv after the hearing.

The party, he said, will have a twofold focus going forward. Firstly, “the individual’s chances of getting good and effective medicines”. And secondly, on “Sweden’s “opportunities to continue to be a leading nation in drug research and development”.

Acko Ankarberg Johansson also reminded the audience that EU elections will be held next summer, after which a new Commission will enter the scene. She added that Sweden will also have to discuss how the rules should be implemented nationally.

[By Monica Kleja – edited by Vasiliki Angouridi | Euractiv.com]

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