Navigating global health policy in a time of disruption
In the EU, the European Commission has proposed significant reform of the pharmaceutical sector with a focus on modernization, adoption of a patient-centered approach, and support for innovation.1 Central to this objective is to ensure better access to affordable medicines for patients across the EU and give patients greater access and control of their own health data.2
As the industry navigates this new environment in both the U.S. and EU, it is important to ensure the right drug gets to the right patient without delay. During a period of continuous change and uncertainty, achieving this objective requires agility and capability.
Changes in the EU
The introduction of joint clinical assessments (JCAs) promises a more harmonized and inclusive framework for assessments across member states, and in doing so, enhances the quality and consistency of those assessments while promoting greater transparency. The JCA will evaluate the degree of certainty of the relative effectiveness and relative safety of a product, weighing the strengths and limitations of the available evidence.
The JCA analysis is prepared by the pharmaceutical or biotechnology company, known as the Heath Technology Developer (HTD), and then assessed by the HTA bodies. Assessment starts with the scoping process, which defines the research questions that HTDs need to address as part of their submission. The process uses the PICO framework (population, intervention, comparator, outcome) to formulate these questions. The scoping process attempts to survey the needs of all Member States and then consolidate their input into a unified scope for manufacturers.
Also embedded in the HTAR framework is the joint scientific consultation (JSC), which allows companies to get advice from EMA and HTA bodies in Europe simultaneously.4 The JSC provides non-binding scientific advice before the start of pivotal clinical trials with the objective of supporting a clinical trial design that supports both regulatory objectives and HTA criteria.
It is important to emphasize that the JCA does not include pricing and reimbursement negotiations, which remain under the remit of the individual member states. However, it is thought that HTA bodies will give due consideration to the conclusions from the JCA process, and this will likely influence local decision-making.
Changes in the U.S.
What a new U.S. administration and Congress means for healthcare
There are also signs that the Affordable Care Act (ACA) exchange plan subsidies will not be extended in 2026, resulting in higher premiums and decreased coverage and access for patients.
Other significant changes to the health policy environment are a freeze on public health initiatives, a reduction in healthcare agency research staff, and cuts in funding, putting several health assistance programs at risk.
All these proposed changes to healthcare policy are likely to create additional need for patient assistance programs (PAPs) to help patients gain access to medications.
Separately, several states have taken their own steps to tackle prescription drug affordability through prescription drug affordability boards (PDABs). PDABs are state-level boards that review prescription drug costs with the goal of reducing them. As of December 2024, 11 states had introduced PDAB legislation, but these vary in terms of how far along they are in development and implementation of the programs.6,7
Inflation Reduction Act (IRA)
Additionally, a significant proportion of standalone prescription drug plans (PDPs) saw increases in premiums and a reduction in the number of available plans for each geographic region in 2025. In 2026, there is likely to be further destabilization of the PDP market, which could result in more patients to Medicare Advantage plans.
Some other concerning issues is access to Medicare negotiated products in 2026, particularly its financial impact on pharmacies. Independent pharmacies are warning that they will face a cash flow crisis because of the economics of dispensing and the delay in getting reimbursed by plans.9 Some pharmacists say they may be forced to consider not stocking the negotiated medicines or resort to staffing cuts and pharmacy closures. One study warned that over 90% of independent pharmacies are at least considering not stocking negotiated drugs.10
The key in this changing climate will be to assess the impact of policy changes on patient populations and programs. The pharmaceutical industry’s emphasis should be on a patient-centered approach to healthcare, advocating for policies that prioritize patient needs and experiences. By engaging with patient advocacy groups and ensuring patient voices are heard in policy discussions, stakeholders can play their part in driving positive changes in the healthcare system.
Preparing for regulatory and legislative changes
Biopharmaceutical companies must remain agile in order to respond to EU legislation and the challenges posed by the new U.S. administration and Congress. By preparing for these changes, organizations can better position themselves to ensure that patients receive timely access to the right treatments at the right time.
Strategic thinking will be essential in addressing the complexities of policy shifts, particularly in understanding the implications of JCAs in Europe, pricing negotiations, and changes in ACA plan affordability and the impacts of the IRA in the U.S. Companies must engage with patient advocacy groups to prioritize patient needs, ensuring that their voices are reflected in policy discussions.
By focusing on innovation, collaboration, and a patient-centered approach, the industry can effectively navigate these challenges, ultimately improving healthcare outcomes for individuals across the world.
This article summarizes Cencora’s understanding of the topic based on publicly available information at the time of writing (see listed sources) and the authors’ expertise in this area. Any recommendations provided in the article may not be applicable to all situations and do not constitute legal advice. Readers should not rely on the article in making decisions related to the topics discussed.
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References:
1 Modernising the EU pharmaceutical legislation, European Commission. Modernising the EU pharmaceutical legislation - European Commission
2 European Health Data Space Regulation (EHDS), European Commission. https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space-regulation-ehds_en
3 New EU rules on Health Technology Assessment open up a new era for patient access to innovation, European Commission. https://ec.europa.eu/commission/presscorner/detail/en/ip_25_226
4 Joint Scientific Consultations, European Commission. https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment/joint-scientific-consultations_en
5Medicaid Changes in House and Senate Reconciliation Bills Would Increase Costs for 1.3 Million Low-Income Medicare Beneficiaries, KFF, June 2025. https://www.kff.org/medicaid/issue-brief/medicaid-changes-in-house-reconciliation-bill-would-increase-costs-for-1-3-million-low-income-medicare-beneficiaries/
6 Unanswered Questions And Unintended Consequences Of State Prescription Drug Affordability Boards | Health Affairs
7 States Take Action on Upper Payment Limits to Address Prescription Drug Affordability | MultiState
8 The Inflation Reduction Act and Medicare Drug Price “Negotiation”, PhRMA. https://phrma.org/policy-issues/government-price-setting/inflation-reduction-act
9 ASCP and NCPA Announce Joint Recommendations to Manufacturers to Effectuate Medicare’s Maximum Fair Price (MFP), NCPA, June 2025. https://ncpa.org/newsroom/news-releases/2025/06/13/ascp-and-ncpa-announce-joint-recommendations-manufacturers
10 NCPA warns CMS that many independent pharmacies won’t carry MDPN drugs, NCPA, Jan 2025. https://ncpa.org/newsroom/qam/2025/01/28/ncpa-warns-cms-many-independent-pharmacies-wont-carry-mdpn-drugs
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