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The impact of EU pharmaceutical reform

18 Jun 2024 | By Brand Engagement Team
Uniphar was delighted to welcome European industry leaders to Zurich to debate the proposed EU pharmaceutical legislation reform, and incoming HTA reform. The conversation was held against the backdrop of the EU elections, and discussions focused on the impact of both on the pharma industry globally.

With consideration to the proposed changes to pharmaceutical legislation, the attendees of this invite-only event discussed whether the EU would become a less attractive market to launch and commercialise brands. Or whether considered in the balance of reform in the US and growth in China, by comparison its impact will not be as significant as first thought.

Where do we stand?

Opening the evening meeting, Sarah Bosworth, Associate Partner at H/Advisors Cicero, summarised Uniphar’s White Paper reviewing the EU Commission’s original proposals and recent revisions by the EU Parliament.

The regulatory and legislative changes are divided into seven key categories:

  1. Regulatory data protection (RDP)
  2. Supply of products to EU Member States
  3. Orphan drug incentives
  4. Antimicrobial resistance
  5. Security of supply and shortage prevention
  6. Sustainability, transparency and reporting
  7. Cross-cutting regulatory measures

Sarah framed the reform as, “The most significant legislation for industry for a generation, seeking to address longer term challenges to health policy integration across Europe – focusing on improving accessibility and affordability of medicines.”

To understand the potential impact of these reforms in more detail, download the White Paper Reform of EU Pharmaceutical Legislation – Where Do We Stand?

A reasonable deal?

Thoughts on the impact of the pharmaceutical legislation reform were mixed amongst attendees, who were all senior members of the European life sciences industry.

Some suggested that the reform could be a reasonable deal especially in comparison to developments in the rest of the world, specifically reform in the US and growth and innovation in China. It could see the EU market look more reasonable and the reform become “the new status quo”.

With concern around intellectual property protection being cut, one attendee noted that RDP is only one form of intellectual property, and although the reform sees the duration of RDP reduced, most companies have other patents which will last longer than the proposed revised timeline.

In this case, it will have an impact but that is likely to be offset, or mitigated, by other patents which will ensure 15-16 years of exclusivity.

A poll of attendees indicated that most have taskforces or working groups within their companies that are exploring the reform proposals and considering their impact. As expected, it is high on the agenda.

EU HTA reform

Following the pharmaceutical regulatory reform debate, Life Sciences Leader, Haseeb Ahmad, summarised the EU HTA reform. The EU-level joint clinical assessments are the cornerstone of the reform and are intended to be collaborative assessments drawing on input from Member States. They are designed to reduce duplication allowing for relevant clinical data to be submitted once for use across all Member States.

The EU HTA framework came into force in January 2022, and will start to apply from January 2025 for oncology, advanced therapies and medical devices. For orphan medications, it will be implemented in January 2028, and all medicines will follow in January 2030.

Haseeb explained that for those with the right research programme and clinical package, who can show a better standard of care, it can give the company a great lever. But he reminded the attendees that the European HTA is a clinical assessment and doesn’t replace country HTA or affect pricing and reimbursement. Responsibility for where an asset offers value for money and budget impact is the local responsibility of a Member State.

He discussed how it sets clear rules of engagement and can be beneficial for innovative products.

It holds opportunity for those companies who are first to market, giving them a critical advantage, but for those following in second or third to market, it is undetermined whether it will speed up reimbursement. On the counter, it may lead to joint procurement for high budget impact treatments.

One of the attendees raised a concern that adoption of the HTA dossier is not mandatory, so Member States can disregard it in favour of their own clinical assessment, which doesn’t necessarily reduce the duplication or clinical assessment burden that it set out to achieve.

Those attendees specialising in oncology are already working through the HTA framework to ensure they are prepared for January 2025.

The future for the EU pharma industry

Of the two topics discussed at the dinner, the pharmaceutical legislation reform is higher up the agenda than the HTA, though both are vital considerations.

Given its priority amongst industry and with the event being held on the first day of the EU elections, the final legislative reform is very much up for review.

As the Council explores its amendments and hears submissions from Member States, it is clear that there will be differing positions on how countries perceive the legislation will impact them. Added to this, the two most significant MEPs responsible for the revision of the legislation may no longer hold their positions in the Parliament following the elections.

Whatever the election outcome, the reform won’t happen in the next few months, but is certainly likely to be within the next Parliamentary term. The Council’s revisions are expected by September 2024 at the earliest, after which time negotiations will begin between the Parliament and Council until a final agreement on the text is reached. This is anticipated to take least 12 months, with the legislation likely to be finalised by 2026 at the earliest and around another 18 months for implementation.

To read more about reform of the EU pharmaceutical legislation, download the White Paper, Reform of EU Pharmaceutical Legislation – Where Do We Stand?