In the early hours of 11 December, the Council and the European Parliament finally reached an agreement on the “pharmaceutical package”. While the original intention was to improve patient access to medicines in the EU, the final phase of negotiations was shaped by new narratives around competitiveness that largely benefited the pharmaceutical industry. Despite some improvements on transparency within the pharmaceutical ecosystem, Salud por Derecho considers that the final text does not address the structural problems that hinder equitable access to medicines in Europe, and represents a missed opportunity —after more than two decades— to position the region as a global reference in pharmaceutical policy aligned with the right to health.
Regulatory exclusivities: “more is better” and other evidence-free dogmas
The main stumbling block in the negotiations was regulatory exclusivities. These automatically extend monopoly regimes and go beyond obligations under the TRIPS framework. The agreement reinstates 8 years of data protection and 1 year of market protection (plus an additional year if certain conditions are met, such as addressing an unmet medical need, with a cap on total possible regulatory protection on 11 years), overturning the Commission’s initial proposal to shorten these periods. This happens despite the lack of evidence linking longer protection periods with greater innovation. In contrast, there is extensive evidence showing the direct impact these monopolies have on treatment affordability and on delaying the entry of generics and biosimilars, especially in a European context marked by rising prices.
As we stressed throughout the negotiations, the basic data protection period should not have been expanded under any circumstances, given its restrictive effect on competition. The central question ignored by co-legislators is not whether incentives should exist, but what return they provide to the public that ultimately finances them. The political debate has focused on whether more or fewer incentives are needed, when the truly relevant question is: incentives — for what, and in exchange for what? If incentives are meant to help companies recover R&D investments, they must be conditioned on clear obligations: transparency of development costs, transparency on how the final price is set, guaranteed supply, and global access plans.
Transparency: a limited step that does not meet public-interest demands
The reform introduces some improvements on transparency, but remains insufficient to ensure genuine accountability. While we welcome the obligation to disclose part of the public funding received, the agreement leaves out essential elements needed to understand the true public contribution to medicine development. The provisions go beyond the current situation but represent a step back from what the European Parliament and civil society demanded: disclosure of indirect public financial support, one of the main forms of subsidising the pharmaceutical industry and a key factor influencing final price negotiations.
The agreement also omits the requirement to disclose early-stage funding, licences, or acquisitions carried out by independent entities during earlier phases of development. This information is crucial to reconstruct the full chain of public and private investments and to ensure that any additional EU incentive is based on a fair assessment of the risks assumed by each party.
Without strong transparency and conditions that link incentives to clear obligations —such as accessible net prices, guaranteed supply, and global access plans— the system risks replicating the same dynamics that have driven high prices and increasing pressure on health systems. Europe cannot afford to prolong monopolies without demanding a proportional public return.
Orphan medicines: failure to redefine criteria to prevent abuses
Although the agreement introduces improvements such as a public register of orphan medicines, it still maintains long exclusivity periods (up to 11 years) without incorporating any economic criterion to assess whether these incentives are genuinely needed to stimulate investment. We also recall that the original purpose of orphan drug incentives was to correct a lack of profitability. For this reason, Salud por Derecho has consistently argued that return on investment (ROI) should be a binding criterion for granting orphan designation and for extending or revoking exclusivities. Shorter exclusivity periods could be extended only if investment has not yet been recovered, and should be withdrawn when significant profitability is demonstrated.
Antimicrobials: an unpopular proposal — and a (relative) piece of good news
Salud por Derecho regrets that the agreement maintains transferable exclusivity vouchers, despite clear evidence of their ineffectiveness as an innovation incentive, their significant indirect costs, and broad opposition from the pharmaceutical ecosystem.
A small safeguard is included: the blockbuster cap, which prevents the voucher from being applied to medicines generating more than €490 million annually in their first four years —far from the EU’s estimated “fair share” contribution to global AMR innovation (€1 billion). While this limits monopoly extensions for highly profitable products, it does not address the structural flaws of the voucher: poor cost-effectiveness, disproportionate social cost, and difficulty enforcing continuous supply and responsible stewardship. In short, the voucher does not guarantee useful innovation or access —particularly considering the EU’s fair-share estimate.
In contrast, we welcome the inclusion of a voluntary subscription model for joint procurement of antimicrobials —a delinked, revenue-guarantee mechanism aligned with international recommendations and our own position. However, it remains unclear whether this model will include a global access plan, as proposed by Parliament in Article 39b and demanded by civil society. To be effective, the model must include strong obligations on global access, licensing, supply, stewardship, transparency and environmental responsibility.
Greater weight for environmental impact assessments
Despite opposition from the pharmaceutical industry, Salud por Derecho welcomes the inclusion of a binding criterion allowing the rejection of marketing authorisation when the environmental risk assessment is incomplete, insufficient, or does not adequately address identified risks. This is an important step towards regulation aligned with public health and environmental protection objectives, especially in the context of increasing pharmaceutical pollution and antimicrobial resistance.
Overall assessment: an insufficient and unbalanced reform
Although the agreement incorporates advances on transparency and support for antimicrobial R&D, it fails to correct the fundamental imbalances of the European pharmaceutical system. Poorly targeted incentives, excessive exclusivity periods and a lack of conditionality continue to compromise the sustainability of European health systems. Key details —such as the hospital exemption— also remain unclear.
Europe has missed a historic opportunity to modernise its pharmaceutical policy from a public-interest perspective. The upcoming Critical Medicines Act, the EU Biotechnology Act, and negotiations on the next long-term EU budget (MFF), particularly Framework Programme 10 (Horizon), will be critical opportunities to reverse this trend and advance toward genuine access to medicines.
