Health
Sweden and Denmark Respond Unevenly to New EU Pharma Deal
EU Pharma Deal Draws Praise and Criticism from Sweden and Denmark
The European Council's recent agreement on the pharmaceutical package has triggered both support and concern in Sweden and Denmark, reflecting a mixed response across political and industry lines.
Supporters applauded the decision to maintain the eight-year regulatory data protection (RDP) period for new medicines — a key victory for Sweden and Denmark, which formed part of a blocking minority opposing the European Commission’s original proposal to cut the period to six years. The European Parliament had proposed a compromise of seven and a half years, but after two years of negotiation, the eight-year term prevailed.
“We are pleased that Member States supported our position on data protection. This is a significant achievement for Sweden and for EU patients,” said Acko Ankarberg Johansson, Sweden’s Minister for Healthcare.
Sophie Løhde, Denmark’s Minister of Interior and Health, added:
“Although negotiations were difficult, the outcome represents a clear improvement over the original proposal. We now look forward to finalizing the deal with the European Parliament.”
Industry Reactions: Applause and Alarm
While the Danish pharmaceutical industry welcomed the decision on data protection, not all reactions were positive.
“It appears we’ve succeeded in retaining the eight-year RDP period, thanks to strong efforts from our Health Ministry and Minister Løhde,” said Ida Sofie Jensen, CEO of LIF, the trade association representing Denmark’s research-based pharma companies. “Still, there are elements in the deal that remain less than ideal.”
In contrast, the Confederation of Danish Industry (DI) voiced disappointment. Its CEO, Lars Sandahl Sørensen, warned that the agreement could stifle drug innovation and weaken the EU’s global pharmaceutical competitiveness.
Antimicrobial Resistance and the Bolar Exemption
One of the key criticisms revolves around the weakened provisions to fight antimicrobial resistance (AMR).
The agreement expands the Bolar exemption, allowing generic manufacturers to conduct studies and trials on patented medicines before patent expiry. While this may accelerate market access for generics, Sweden raised concerns that it could undermine the life sciences sector and reduce the incentive for innovation.
The proposal also introduces conditional market exclusivity extensions — with up to two years of additional protection available, including one year for medicines addressing unmet medical needs. Though Sweden accepted the agreement, it cautioned that these measures may not support long-term innovation.
Stine Bosse, Danish MEP and vice-chair of the European Parliament’s SANT Committee, said:
“Patients must remain our central focus. Without strong action on AMR, this deal falls short of its promise to support a sustainable healthcare system.”
Transferable Exclusivity Vouchers: A Controversial Incentive
To boost innovation in antibiotic development, the deal introduces Transferable Data Exclusivity Vouchers (TEVs). These vouchers offer an additional one-year RDP extension to companies that develop critically needed antimicrobials. The vouchers are transferable and may be sold or used for another product.
However, the Council limited the number of vouchers to just five, down from the original proposal of ten — a move that disappointed advocates.
“No new antibiotics have been introduced for decades,” said Jakob Forssmed, Sweden’s Minister for Social Affairs. “This isn’t just a market issue. We need strong, public incentives.”
Next Steps: Trilogues Begin
The Council’s position now heads to the trilogue stage — a three-way negotiation between the European Council, Commission, and Parliament — beginning 17 June.
Jessica Polfjärd, Sweden’s sole MEP in the SANT Committee, welcomed the progress:
“It’s encouraging to see the Council reach a position. We must now move swiftly to finalize this agreement, which is crucial for European competitiveness, public health, and access to essential medicines.”
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