Global Pharma Market Access Under Pressure

Pharma market access is no longer just a regulatory hurdle, it’s a geopolitical challenge.
With the EU’s new HTA regulation, U.S. pricing reforms, potential Trump tariffs, and legislative shifts in key markets, pharmaceutical access is facing cross-border disruption.

Manufacturers must realign their strategies to sustain revenue and reach patients.

Let’s break down how each region’s policies are reshaping global market access.

EU Health Technology Assessment (HTA) Reform and Its Industry Impact

What Is the EU HTA Regulation?

From January 2025, the EU enforces a unified HTA process across member states, starting with oncology and ATMPs.
The regulation mandates a Joint Clinical Assessment (JCA) for eligible medicines, replacing 27 separate national evaluations.

The goal?

Streamline access, reduce duplication, and enable faster uptake of innovative therapies.

However, national authorities still control pricing and reimbursement decisions. This means while clinical benefit will be assessed centrally, commercial pathways remain fragmented.

Companies must now submit their data under both EMA and HTA timelines. This dual-track demands early planning and cross-functional alignment.

For manufacturers, the shift brings mixed results:

Pros: Harmonized clinical evaluation can reduce redundancy and delay.
Cons: No harmonization of pricing decisions across EU nations.

Early dialogue with HTA bodies, and alignment of regulatory and access milestones, is essential to avoid bottlenecks.

Joint Clinical Assessments (JCA): Opportunities and Risks

JCAs offer a single, scientifically robust evaluation for clinical effectiveness. But success depends on whether national bodies adopt the JCA outcomes or challenge them.

Risks for pharma companies include:

Rejection or re-evaluation by national HTA agencies
Delays due to misaligned submission timelines

Pressure to adjust launch sequences based on access hurdles

The opportunity lies in leveraging a strong JCA to fast-track decisions in countries with aligned evaluation criteria.

Preparation is key:

Align pivotal trial endpoints with JCA requirements
Anticipate variations in country-level value frameworks
Invest in evidence generation to support multiple jurisdictions

JCAs may ease the burden long-term, but in the short-term, they add complexity.

U.S. Drug Pricing Policy: IRA, Inflation Caps, and 2025 Outlook

Medicare Drug Price Negotiation: Scope and Limitations

The Inflation Reduction Act (IRA) has redefined drug pricing in the U.S.
By 2025, Medicare can negotiate prices for a growing list of high-cost drugs.

Initial price caps will impact Part D drugs with no generic competition and high Medicare spend.
More products will be added each year.

Limitations:

Negotiation only applies to Medicare, not commercial payers.
Small molecule drugs must be on the market 9 years, biologics 13, before negotiation begins.

Still, the impact is significant:

Manufacturers must reassess launch pricing strategies.
Revenue forecasting becomes uncertain for top-selling therapies.-

Additional inflation rebates penalize price hikes above CPI rates, further pressuring margins.

How a Trump Presidency Could Reshape Pricing Policy

As Donald Trump returned to the White House in 2025, his previous price control policies including international reference pricing has been revived.

Key risks:

Executive actions to import foreign price caps
Reinstatement of “most favored nation” models
Greater scrutiny of pharma profitability

While less institutional than the IRA, Trump’s approach is more aggressive.
It bypasses Congress, relying on CMS to execute sweeping changes.

Market access leaders must plan for both scenarios continued IRA rollout or disruptive policy shifts under new leadership.

Either way, pricing pressure in the U.S. will intensify.

Tariffs and Trade Policy: The Hidden Costs of Protectionism

Pharmaceuticals were once largely exempt from tariffs, but that’s no longer the case.

With President Donald Trump back in the White House and having already reignited his tariff agenda, trade tensions have escalated sharply, particularly between the U.S. and China.

The consequences are significant:

Raw material costs are rising due to tariffs on active pharmaceutical ingredients (APIs).
European and U.S. pharma companies are facing retaliatory measures in key Asian markets.
Contract manufacturing in countries like India and China is becoming less stable and more expensive.
Trump’s revived tariffs now target critical imports, including generics and essential medical equipment.

In this new landscape, pharmaceutical companies must:

Diversify their supply chains to reduce dependency
Re-assess manufacturing hubs for geopolitical resilience
Integrate trade policy risks into financial and operational models

Protectionist policies increase production and launch costs delaying innovation and limiting patient access globally.

Global Legislative Shifts: Diverging National Access Strategies

Decentralized Pricing and Localized Barriers

While some regions centralize HTA, others tighten national control. Germany’s AMNOG reforms, France’s value-based pricing shift, and China’s reimbursement negotiations all point to rising autonomy.

Countries are using legislation to prioritize local cost-containment:

Tightening budget impact thresholds
Mandating price cuts post-launch

Delaying new therapy inclusion in reimbursement lists

This leads to:

Slower launches in cost-sensitive markets
Prioritization of high-income countries
Widening inequality in therapy access

Global access planning must become granular. In Simple words, “What worked in 2020 no longer applies in 2025“.

Strategic Recommendations for Market Access Teams

Begin access planning during Phase II development
Align clinical trials with HTA evidence requirements
Invest in local market intelligence and stakeholder mapping
Model multiple pricing scenarios (IRA, tariffs, JCA outcomes)
Secure early advice from regulatory and HTA bodies
Build flexible, region-specific launch pathways
Include trade and political risk in global pricing strategy

Pharma success in 2025 depends less on innovation alone and more on strategy.

Conclusive Thoughts

Therefore, Pharma market access is caught in a shifting geopolitical and policy landscape. From centralized assessments in the EU to volatile U.S. pricing, from tariffs to local legislative reforms, access strategy is more complex than ever.

Companies must evolve their planning, integrating policy foresight, flexible pricing models, and adaptive evidence strategies.

Those who adapt early will capture both market share and patient trust.