Major changes in the European Union (EU) and United States (US) healthcare markets are poised to reverberate across the globe. In early 2025, the EU implemented a Joint Clinical Assessment (JCA) as part of a new health technology assessment regulation, aiming to harmonize how new therapies are evaluated across all member states.[1] Around the same time, the US government revived a “Most Favored Nation” (MFN) drug pricing policy via executive order, seeking to tie U.S. drug prices to those in other developed countries.[2] These developments, one focusing on unified clinical evidence and the other on international pricing, signal a significant shift in the two largest pharmaceutical territories. For pharmaceutical manufacturers serving the Gulf Cooperation Council (GCC) region, these changes bring both challenges and opportunities.

The EU Joint Clinical Assessment: One Evaluation for 27 Countries

The new EU JCA introduces a single EU level clinical evaluation for new medicines, beginning with oncology and cell and gene therapies in 2025.[1] It focuses on clinical benefit and safety, while each country retains control over pricing and economic evaluation. The JCA runs in parallel with EMA approval and provides a unified clinical evidence report for all member states.[1-3]

For manufacturers, a successful JCA allows one dossier to support HTA decisions across Europe, theoretically reducing duplication and enabling earlier launches, especially in smaller markets.[4] It also presents challenges, including meeting diverse evidence expectations and the potential for earlier price erosion through wider reference pricing.[4]

Most importantly, this additional review process has resulted in significant uncertainty, uncertainty on evidence review criteria, uncertainty on review timelines and uncertainty on how subsequent in-country reviews would be undertaken, if at all.

The US “Most Favored Nation” Pricing Model: Global Price Pressure

In May 2025, the US introduced an MFN policy that ties US prices of new medicines to the lowest price in selected high income OECD countries (Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Ireland, Israel, Italy, Japan, The Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, and the United Kingdom).[2,5] The policy applies across Medicare, Medicaid, and private market launches and aims to reduce US drug spending.[2]

For manufacturers, MFN is highly disruptive given a low price abroad can constrain US pricing, prompting companies to reconsider global launch sequencing.[2] Delays or withdrawals in lower price markets may become more common to avoid setting restrictive benchmarks. MFN also increases uncertainty in international pricing. Traditional high price markets may no longer serve as isolated anchors, and companies may prioritize launches in regions not referenced by MFN.[5] 

Becoya’s Viewpoint: Global Shifts, Regional Strategy

The shifts in the EU and US create an opportunity for the GCC to play a more prominent role in global launch planning. As clinical evidence becomes more centralized through the EU JCA and pricing pressure grows under the US MFN policy, manufacturers may look to regions that offer regulatory clarity and pricing stability. Saudi Arabia and the UAE have already strengthened HTA capabilities, accelerated regulatory pathways, and expanded economic evaluation requirements, positioning the GCC well for earlier consideration in global strategies.

These trends mean companies can increasingly file for market authorization in parallel to the US/EU. Doing so can mitigate the downstream effects of MFN and reference pricing while enabling earlier market entry for high value therapies. 

With continued alignment and proactive engagement between regulators and industry, the GCC can evolve into a more strategic launch region, supporting timely and sustainable access to innovative treatments across the MENA region.

References:

1. 1. Calderwood, S., Xue, Y., Oza, P., & Iervolino, A. (2025, January 7). Surveying the shifting landscape in European market access (Part 3: The JCA – expectations and strategic implications)
   2. Frappe, A. (2025, October 13). Most favored nation policy: Outlook & implications beyond. Pharmaceutical Executive
   3. Johns, A., Andrade, A., Johal, S., & Ryan, J. (2025). EU Joint Clinical Assessment: A Framework for Optimising Use with Cost-Effectiveness Decision-Making. Journal of Market Access & Health Policy, 13(4), 52
   4. L.E.K. Consulting. (2024). Transitioning to EU-wide health technology assessments: Implications for pharma
   5. Charles River Associates. (2025, July 15). Potential MFN impact