Industry Stakeholders Express Support for Revision of Switzerland’s Therapeutic Products Act

**Industry Stakeholders Express Support for Revision of Switzerland’s Therapeutic Products Act**

*Bern, Switzerland – June 2024* — A broad coalition of pharmaceutical companies, healthcare professionals, patient advocacy groups, and regulatory experts have expressed strong support for the proposed revisions to Switzerland’s Therapeutic Products Act (TPA), signaling a pivotal moment in the evolution of the country’s healthcare and pharmaceutical regulatory framework.

The Therapeutic Products Act, originally enacted in 2002, governs the development, approval, manufacture, and distribution of therapeutic products in Switzerland, including pharmaceuticals and medical devices. The Swiss Federal Council initiated the revision process in response to rapid advancements in medical science, digital health technologies, and the growing need for regulatory harmonization with international standards.

### Key Objectives of the Revision

The proposed amendments to the TPA aim to:

1. **Enhance Patient Safety and Transparency**
The revised act would introduce stricter post-market surveillance requirements and improved reporting mechanisms for adverse events. It also seeks to increase transparency in clinical trials and product approvals, ensuring patients and healthcare providers have access to comprehensive safety and efficacy data.

2. **Facilitate Innovation and Access**
By streamlining regulatory pathways for novel therapies, such as gene and cell therapies, the revision aims to reduce time-to-market for innovative treatments. It also includes provisions to support early access programs for patients with unmet medical needs.

3. **Strengthen International Collaboration**
The revision aligns Swiss regulations more closely with those of the European Union and other international bodies, such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This alignment is expected to facilitate cross-border clinical trials and product approvals.

4. **Modernize Digital Health Regulation**
Recognizing the growing role of digital therapeutics and health data, the revised TPA introduces a framework for the regulation of software-based medical devices and the secure use of health data in research and treatment.

### Industry and Stakeholder Reactions

The proposed changes have been met with widespread approval from key industry stakeholders.

**Interpharma**, the association representing Switzerland’s research-based pharmaceutical companies, issued a statement praising the revision as “a forward-looking step that balances innovation with patient safety.” CEO René Buholzer emphasized that “the updated TPA will help maintain Switzerland’s position as a global leader in life sciences and ensure that patients continue to benefit from the latest medical advances.”

**Swissmedic**, the national regulatory authority for therapeutic products, welcomed the revision, noting that it would provide the agency with enhanced tools to oversee the safety and efficacy of increasingly complex therapies. “The new provisions will allow us to respond more effectively to emerging health technologies and ensure robust oversight,” said Swissmedic Director Raimund Bruhin.

Patient advocacy organizations, including the **Swiss Patient Organization (SPO)**, also voiced support, particularly for the act’s emphasis on transparency and early access. “Patients stand to gain from faster access to life-saving treatments and greater involvement in the regulatory process,” said SPO spokesperson Martina Keller.

### Challenges and Considerations

Despite the broad support, some stakeholders have raised concerns about implementation timelines and resource requirements. Smaller biotech firms have called for additional guidance and support to navigate the new regulatory landscape, while healthcare providers have emphasized the need for training and education on new compliance standards.

Legal experts have also pointed to the importance of ensuring that data privacy protections are robust, especially in light of the expanded use of digital health tools and real-world evidence in regulatory decision-making.

### Next Steps

The revised Therapeutic Products Act is currently under parliamentary review, with a final vote expected later this year. If approved, the new provisions would be phased in over a two-year period, allowing stakeholders time to adapt to the updated requirements.

The Swiss Federal Office of Public Health has committed to ongoing dialogue with industry and public health partners throughout the implementation process. Public consultations and stakeholder workshops are scheduled for the coming months to ensure a smooth transition.

### Conclusion

The revision of Switzerland’s Therapeutic Products Act marks a significant step toward modernizing the country’s healthcare regulatory system. With strong support from across the healthcare ecosystem, the updated legislation promises to enhance patient safety, foster innovation, and strengthen Switzerland’s role in the global life sciences sector. As the country prepares for the next phase of implementation, all eyes will be on how these reforms translate into tangible benefits for patients, providers, and the broader healthcare community.