Industry Stakeholders Express Support for Revision of Switzerland’s Therapeutic Products Act
**Industry Stakeholders Express Support for Revision of Switzerland’s Therapeutic Products Act**
*June 2024 – Bern, Switzerland*
Switzerland’s healthcare and life sciences sectors are voicing strong support for the proposed revision of the Therapeutic Products Act (TPA), a key legislative framework that governs the regulation, approval, and monitoring of therapeutic products in the country. The revision, which is currently under parliamentary review, aims to modernize regulatory processes, enhance patient safety, and align Swiss pharmaceutical standards more closely with international best practices.
### Background: The Therapeutic Products Act
First enacted in 2002, the Therapeutic Products Act provides the legal foundation for the regulation of pharmaceuticals, medical devices, and other therapeutic products in Switzerland. Administered by Swissmedic, the Swiss Agency for Therapeutic Products, the TPA ensures that only safe, effective, and high-quality products reach the Swiss market.
Over the past two decades, rapid advancements in biotechnology, digital health, and personalized medicine have transformed the healthcare landscape. In response, Swiss authorities initiated a comprehensive review of the TPA to ensure that the regulatory framework remains fit for purpose in a fast-evolving global environment.
### Key Proposed Revisions
The proposed amendments to the TPA include several significant changes:
1. **Streamlined Approval Processes**: The revision introduces accelerated pathways for innovative therapies, including orphan drugs and advanced therapy medicinal products (ATMPs), to reach patients more quickly.
2. **Digitalization and Real-World Data**: The updated law encourages the use of digital tools and real-world evidence in regulatory decision-making, supporting more dynamic and data-driven assessments of therapeutic products.
3. **Enhanced Transparency and Communication**: The revision mandates greater transparency in clinical trial data and regulatory decisions, fostering public trust and informed decision-making among healthcare providers and patients.
4. **International Harmonization**: The changes aim to align Swiss regulations more closely with those of the European Union and international bodies such as the International Council for Harmonisation (ICH), facilitating cross-border collaboration and market access.
5. **Strengthened Post-Market Surveillance**: The revised law enhances pharmacovigilance and post-market monitoring requirements to ensure ongoing safety and efficacy of products after approval.
### Industry Response
Leading pharmaceutical companies, biotech firms, and medical device manufacturers have expressed strong support for the proposed revisions. The Swiss Biotech Association, Interpharma (the association of research-based pharmaceutical companies in Switzerland), and the Swiss Medtech industry group have all issued statements welcoming the changes.
“These revisions are a necessary and timely step toward ensuring that Switzerland remains a global leader in pharmaceutical innovation,” said Dr. Simone Keller, spokesperson for Interpharma. “By streamlining regulatory pathways and embracing digital innovation, the revised TPA will help bring life-saving therapies to patients faster while maintaining high safety standards.”
The Swiss Biotech Association emphasized the importance of international harmonization, noting that alignment with EU and global standards will reduce regulatory burdens for companies operating across borders and enhance Switzerland’s competitiveness as a hub for life sciences.
### Patient and Healthcare Community Perspectives
Patient advocacy groups and healthcare professionals have also largely welcomed the proposed changes, particularly the increased transparency and improved access to innovative treatments. However, some have called for additional safeguards to ensure that accelerated approval pathways do not compromise patient safety.
“We support faster access to new therapies, but it’s crucial that safety and efficacy remain the top priorities,” said Dr. Markus Huber, president of the Swiss Medical Association. “The revised TPA strikes a good balance, but ongoing oversight and stakeholder engagement will be essential.”
### Next Steps
The revised Therapeutic Products Act is currently under consideration by the Swiss Federal Assembly, with a final vote expected later this year. If approved, the new provisions could come into effect as early as 2025, following the necessary implementation and transitional measures by Swissmedic and other regulatory bodies.
### Conclusion
The proposed revision of Switzerland’s Therapeutic Products Act marks a significant milestone in the country’s commitment to innovation, patient safety, and global regulatory alignment. With broad support from industry stakeholders, healthcare professionals, and patient advocates, the updated legislation is poised to strengthen Switzerland’s position as a leading center for therapeutic product development and regulation in the 21st century.