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The EU is the world’s second-largest market for medical and pharmaceutical products and is both a major importer and exporter of such products, albeit with a trade surplus of over 100 billion Euros per year. The EU is also a leader in pharmaceutical sector research and development. The EU’s new Pharmaceutical Strategy (November 2020) seeks to build on this strong position to foster improved, patient-centric health care and further strengthened industry, including through trade and international cooperation.

Similarly, while Singapore is a much smaller market, it is a leading centre for biomedical sciences in Asia, with European industry having a significant manufacturing presence in Singapore. Between the EU and Singapore, medicaments, medicinal products and pharmaceutical products accounted for over 6 billion Euros of trade – some of the most traded products between both jurisdictions.

The sector is characterised by multi-layered regulation, spanning from intellectual property to safety to pricing and reimbursement. This poses challenges for trade and investment. While their systems are quite different, the EU, its Member States and Singapore share the ambition for modern, forward-looking regulation and administration of the public health sector, including pharmaceuticals and medical devices – as much as they share a host of common challenges and opportunities, from ageing populations to the digitalisation of healthcare.

The EU-Singapore Free Trade Agreement (EUSFTA), which entered into force on 21 November 2019, promotes the trade in pharmaceutical products and medical devices between the EU and Singapore. The EU and Singapore not only agreed on keeping tariffs on these products at zero, but also agreed to prevent and eliminate non-tariff barriers to bilateral trade, establish competitive market conditions, promote innovation and timely access to safe and effective pharmaceutical products and medical devices, foster the use of WHO, OECD and other international standards, and enhance cooperation between the respective health authorities.

This webinar will provide practical insights into trade in the pharmaceutical products and medical devices sector between EU and Singapore, and how the EUSFTA provisions on regulations in these sectors can help EU and Singapore companies.

 
Singapore time   Agenda
4.00 – 4.10 pm   Welcome Address

H.E. Iwona PIÓRKO, European Union Ambassador to Singapore

4:10 – 4:15 pm   EU – Singapore Trade (and Investment) in Pharmaceuticals and Medical Devices: A Quick Overview

Speaker: Eugene LIM, Principal, Team Leader, Policy Support Facility Project – Support to the Implementation of the EUSFTA (Co-Founder & Principal, Taxise Asia – WTS Taxise)

4.15 – 5.00 pm   The EUSFTA and Beyond: Trade in Pharmaceutical Products and Medical Devices, Strategies and Perspectives for Cooperation in and between Singapore and the EU

Speakers:

»         Hannes SCHLOEMANN, Director, WTI Advisors, Co-Lead, PSF Project – Support to the Implementation of the EUSFTA

»         Adriana VELAZQUEZ BERUMEN, Health Products Policy and Standards, World Health Organisation

»         Professor David LLEWELYN, Singapore Management University

This session will inter alia look at:

»         Main elements of the EUSFTA relating to pharmaceuticals and medical devices such as applicable tariffs, technical regulations, pricing and reimbursement and intellectual property provisions

»         The regulatory framework in Singapore and the EU for the import and sale of pharmaceutical products and medical devices

»         Strategies and strategic perspectives of the EU and Singapore relating to trade and investment in pharmaceuticals and medical devices

»         The role of bilateral and multilateral regulatory cooperation when setting new standards in the pharmaceuticals and medical devices sectors

»         Intellectual property protection for pharmaceuticals & medical devices in Singapore

»         Joint initiatives in the WTO and elsewhere (e.g. Pandemic Treaty)

5.00 – 5.50 pm   Regulation, Trade and Investment of/in Pharmaceuticals and Medical Devices in and between the EU and Singapore: A Moderated Discussion on Industry Perspectives

Speakers:

»         Jesus RUEDA RODRIGUEZ, Director General, International Affairs, MedTech Europe

»         David JAUCH, Director Government Affairs, Fresenius Kabi & Chair, International Affairs Committee, Medicines for Europe

»         Alex BUDIMAN, Vice President of Regulatory Affairs, Greater Asia, Becton Dickinson (BD)

»         Ada WONG, Asia Public Affairs Lead, Sanofi

»         Henry TAN, Alpha Health Asia, Vice Chair, Medical Technology Industry Group, Singapore Manufacturing Federation

This session will inter alia look at:

»         The reality of market access and other requirements for pharmaceutical and medical device products in Singapore and the EU: Licensing, product registration, marketing authorisations, pricing, reimbursements etc.

»         Experiences of the pharmaceutical and medical device industries in Singapore following the introduction of the EUSFTA

»         Singapore’s role in the pharmaceutical and medical device global value chain; Singapore as a regional hub

»         Investment in pharma and medtech in Singapore

5.50 – 6.00 pm   Conclusions & Takeaways
Moderator: Hannes SCHLOEMANN, Director, WTI Advisors, Co-Lead, PSF Project – Support to the Implementation of the EUSFTA
 

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