Policy Discussions and International Organizations

11th Asia Regulatory Conference

The 11th Asia Regulatory Conference was recently held from 17-21 October 2022 by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the Singapore Association of Pharmaceutical Industries (SAPI). The conference, which took the form of short topic specific webinars, covered ways in which the regulatory landscape could be improved, and what this means for patients, regulators, and industry. Some topics that were covered included regulatory agilities and why this is important to patients, harmonization of regulatory approval, the changing regulatory landscape of Biotherapeutics and Advanced Therapy Medical Products, the effectiveness of the ICH and the importance of delivery the same quality of regulatory standard to patients everywhere. There was a wide range of speakers lending their view including representatives from both AstraZeneca who spoke on the lessons learned throughout COVID-19 in regard to regulatory approval and Pfizer who spoke on their experience with Post Approval Change Management
Protocol (PACMP).

Click here to watch the full video. The AstraZeneca talk begins at 35:52.

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Global Innovation Index 2022 – What is the future of innovation- driven growth?

WIPO has released the 2022 Global Innovation Index with Switzerland once again placing first, for a 12th year in a row. The United States has climbed to take second position and the United Kingdom has stayed in fourth, the same as in 2021. Even though there was an expectation for a decrease in R&D after the COVID-19 pandemic, this has not been the case for many of the large corporate companies, with there being an almost 10% increase in R&D in 2021, reaching a figure of over $900 billion in 2021. Some countries increased their R&D budget spending for 2021, such as Germany, while other such as Japan and the United States didn’t. Intellectual Property filling also continued to increase in 2021 with a rise of 15%. Data was also found that 26 countries are outperforming their development with innovation, including countries such as India and Indonesia.

The Global Innovation Index predicts two new innovation waves to come, contradicting those who believe innovation driven growth is going to stay at a low. The Digital Age innovation wave and the Deep Science innovation wave are predicted to be the next two biggest breakthroughs in innovation, but it is well accepted that these will take time. The Digital Age innovation wave would focus on automation and artificial intelligence, while the Deep Science innovation wave is thought to look at bio- and nanotechnologies which would revolutionise science.

Click here to read the full report.

 

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Building Greater Resilience in Vaccine Manufacturing – McKinsey & Company

Preparing for the next pandemic is a priority for many national public-health leaders and requires them to lay the groundwork to mount an effective vaccine response.

Decision makers could set the stage for vaccine resilience by defining what their countries and regions need; assessing the local capacity to scale production of vaccine doses; identifying gaps and weaknesses in their national and regional vaccine value chains.

Read the full article here.

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Seminar hosted by the Geneva Network about Availability of COVID Solutions

On 5 October 2022, the Geneva Network organized a panel about the possible future implications of expanding the scope of the TRIPS waiver, in particular in relation to innovation and availability of diagnostics, therapeutics, and vaccines for health crises. Innovation Council’s Executive Director Jennifer Brant took part in this panel to share information about how bio-manufacturing infrastructure can be extended, and what policy actions governments can take to accelerate the process. She expressed the view that the June 2022 TRIPS waiver should be tested, and that evidence should be tabled as to the need to expand the waiver’s scope to cover additional categories of COVID health products, before WTO Members take further action.

Click here to watch the virtual meeting.

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Geneva Network Analysis of the TRIPS Waiver

In the coming months WTO Members will continue to discuss whether to modify the TRIPS waiver that was agreed in June 2022 to include COVID therapeutics and diagnostics. Geneva Network has prepared a policy brief that explains why it could be counterproductive to expand the scope of the waiver in this way. The brief is authored by Philip Stevens of the Geneva Network and Prof. Mark Schultz, Director of the Intellectual Property and Technology Law Program at the University of Akron School of Law.

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Why the United States urgently needs patent subject-matter eligibility reform

The law is in a state of disarray that has led to inconsistent case decisions, deep uncertainty in the innovative, investment and legal communities, and unpredictable outcomes in prosecution and litigation. David Kappos, Paul Michel, Corey Salsberg and Matthew Dowd argue that the United States’ legislators must act to ensure the country maintains its long-standing competitive edge in the global innovation race.

Click here to read the full story.

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Compilation of WIPO Case Studies on IP Management by Small and Medium-Sized Enterprises

The WIPO Secretariat has compiled a selection of case studies and success stories obtained from various areas of WIPO, that showcase the use of IP rights by Small and Medium-sized Enterprises (SMEs). They provide a comprehensive overview on how IP is used by entrepreneurs, inventors and creators, to add value to their products, support business growth, create employment and promote economic development.

These stories will be presented from the 17th to the 22nd of October during the Twenty-Ninth Session of the Committee on Development and Intellectual Property (CDIP).

Read the full story.

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USPTO becomes a partner in international green-technology platform, WIPO GREEN

The United States Patent and Trademark Office (USPTO) became a technology partner to the global green-technology platform of the World Intellectual Property Organization (WIPO). WIPO GREEN is a public-private partnership established by WIPO in 2013. Its 145 international partners include major technology companies, intellectual property (IP) offices, business groups, research institutes, and nongovernmental organizations.

The USPTO’s contributions to WIPO GREEN include its own initiatives that are designed to address the challenge of climate change, including:

Click here to read more.

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Making Biologics: Strategies and Policies for Enhancing Capacity

The COVID-19 pandemic has shown that the cost of underinvesting in resilient systems for the development, production, and distribution of health technologies is too high.

This paper introduces biologics, describes opportunities in the sector, and provides insights about the processes for manufacturing them. It also identifies the diverse pathways that countries have used in recent years to develop bio-manufacturing capacity. Finally, it looks to the future to identify the government policies and technology solutions that will enable more countries to join global value chains and to produce these life-saving treatments more safely, quickly, and cost-effectively – to the benefit of patients everywhere.

Click here for the full story.

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