Swissmedic's Dual Triumph

Dr. Sandra Ragaz-Fumia
Partner International Indirect Tax, PwC Switzerland

Philipp Hespe
Partner, Advisory, PwC Switzerland

Dominik Hofstetter
Pharma & Life Science Regulatory, PwC Switzerland

In the ever-evolving landscape of pharmaceutical advancements, Switzerland has emerged as a focal point of regulatory excellence and international collaboration. The stage is set for a new era in healthcare defined by ground-breaking therapies. This moment comes as Swissmedic, Switzerland’s health authority, achieves a dual triumph that holds promise for the Swiss and US pharmaceutical and life science industries.

Background

The New Wave in Healthcare: Advanced Therapy Medicinal Products (ATMPs)

Within the realm of ATMP lies the blueprint for a medical revolution. ATMPs represent a leap forward in medical science, harnessing the body's intrinsic capabilities to heal and regenerate. These therapies span gene therapy medicines that correct genetic anomalies, somatic-cell therapy medicines that modify cells to fight disease, and tissue-engineered medicines that cultivate living tissues to replace or regenerate damaged organs. The prospect of treating diseases at their root while minimising side-effects represents a profound shift in medical care.

Swissmedic’s ATMP Accreditation: Switzerland's Triumph in the Regulatory Arena

At the core of this transformation lies Swissmedic's most recent achievement: the accreditation for Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) inspections for ATMPs published on their website on 9 August 2023. This achievement makes Switzerland the global pioneer in ATMP regulatory expertise. As the first authority to gain this distinction, Switzerland cements its role as a leader in innovation and quality within the pharmaceutical landscape.

Forging Global Collaborations: The Transatlantic Mutual Recognition Agreement (MRA)

Simultaneously, Swissmedic embarked on a collaborative journey with the Food and Drug Administration (FDA) of the United States through an MRA which had been established in late 2022 and went into effect on 27 July 2023. Under this agreement both regulatory bodies harmonise their inspection processes, allowing the acceptance of each other's GMP inspections. This agreement not only ensures the availability of high-quality medicines to patients in both countries, but also serves as a prime example for cooperation in the space of pharmaceutical innovation.

The Power of Two: ATMP Accreditation and Transatlantic MRA

Streamlined Progress

The Transatlantic MRA simplifies the regulatory path for manufacturers in Switzerland and the United States. This agreement cuts down on duplicated efforts by harmonising inspection processes. Manufacturers in the ATMP space can now focus more on innovation and patient-centered solutions rather than navigating and being held back by complex regulations. The path to progress has been streamlined, promising more efficient advances.

Strategic Avenue for Growth

Moreover, Swissmedic’s accreditation and the Transatlantic MRA open strategic avenues for Swiss biopharmaceutical companies to leverage the lowered regulatory barriers as a gateway for their presence in the lucrative US market. This means they can tap into not only the substantial local market demand but also capitalise on the United States' robust R&D infrastructure, while simultaneously benefitting from a favourable regulatory landscape.

On the other side of the Atlantic, US biopharmaceutical companies which focus on ATMPs can in turn benefit from Swissmedic’s ATMP accreditation as well as from the hyper-connected pharma research hub in Switzerland, which provides access to cutting-edge research, innovation and collaborative opportunities with industry leaders in addition to using Switzerland as a gateway to the European market.

In essence, the ATMP accreditation and MRA alignment offer a dual advantage: recognition of Switzerland's expertise and a clear path for biopharma expansion and supercharged growth in the US, Switzerland, and the EU.

“The Mutual Recognition Agreement (MRA) between Switzerland and the USA with regard to Good Manufacturing Practice (GMP) in medicinal products is now in force! This represents a major success for Switzerland as a production location as well as for securing its supply.”

Interpharma,Association of Switzerland’s research-based pharmaceutical industry

More on Switzerland's MRA

Switzerland has reached a mutual recognition agreement with the US for GMP inspections.

Read blog

Looking Forward: What's Next for ATMP Manufacturers

Rising Demand for Personalised Medicine

The global ATMP market is on the brink of substantial growth, with a projected compound annual growth rate (CAGR) of 13.2% over the next years. Valued at roughly USD 7.9 billion in 2020, the market's trajectory is to catapult to an estimated USD 21 billion by 2028. The potential market size for gene therapies is estimated to be a staggering USD 5 trillion^[1]. Moreover, the United States is set to dominate the North American ATMP manufacturing landscape, leveraging a surge in FDA approvals for gene therapy and stem cell treatments to drive demand for advanced therapy medicinal products. This development is fuelled by factors including the prevalence of chronic illnesses, investments in R&D and an increasing demand for personalised medical solutions.

Navigating EU Market Access from Switzerland

Switzerland's role as an ATMP production and distribution hub comes with its share of challenges. The relatively small Swiss market size, combined with EU regulatory restrictions and possible disruptions in the supply chain for commercial distribution and clinical trials, might appear as disincentives. Nevertheless, these obstacles can be effectively addressed through strategic planning.

Biopharmaceutical companies have the opportunity to sustain growth across Europe by implementing well-crafted and resilient supply chains to establish a gateway from Switzerland to the EU market, which is expected to grow to USD 2.9 billion for cell and gene therapies until 2026^[2] and USD 8.5 billion for tissue engineered therapies by 2028^[3].

^{[1] P. Fischer et al. (June 2023). "Unlocking the value of innovative medicines: Insights from the advanced therapy medicinal products (ATMP) innovation systems in Germany and Sweden." Health Policy and Technology, 12(2), Volume 12, Issue 2.

[2] Reference link

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Actionable next steps

For biopharmaceutical companies to capitalise on the developments outlined in this blog post, a clear roadmap can pave the way to sustained growth in the coming years.

Assess Regulatory Needs: Begin by conducting a comprehensive assessment of regulatory requirements, considering the specific ATMPs you are involved with and your target markets. Special attention needs to be paid to Europe, where recent business-critical regulatory changes affect the import, storage and sale of medicinal products where the legal title is with a non-EU established company, as well as environmental regulations due to the extensive use of single-use consumables (e.g. tubing sets) in ATMP manufacturing.
Develop Market Entry Plans: If targeting the US market, leverage the advantages of the transatlantic MRA by creating or updating existing market entry plans. Our experts are happy to help you find a market entry plan tailored to your business and prepare for inspections and ensure your products and facilities meet both Swiss and US regulatory standards.
Prioritise Innovation: Position your company as an innovation leader in the ATMP sector. Leverage the unique offerings of your ATMPs and align them with the evolving regulatory landscape.

Conclusion

Innovation without borders and investing in a better tomorrow

With the weight of Swissmedic's accreditation and the MRA behind them, ATMP manufacturers are empowered to innovate freely and supercharge their future growth. Switzerland's expertise and global collaboration opportunities provide a fertile ground for manufacturers to push the boundaries of healthcare possibilities, the future of personalised treatments is at their fingertips. ATMP manufacturers aren't just creating treatments; they are investing in a brighter healthcare future.

Personalised therapies that target the core of diseases hold immense potential to transform medical care. Both Switzerland and the US are leading the charge in ATMP development and manufacturing, ensuring that safe and effective medical products continue to benefit people worldwide.

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