Policy Discussions and International Organizations

As the SEP Regulation is moving through the European legislative process, questions have been raised as to whether the draft Regulation (a) responds to the concerns raised by the Commission and (b) whether the concerns motivating development of the Regulation exist, based on evidence.

IP Europe has released a series of blogs arguing that the Commission are pushing through new legislation without evidence to support the decision. In the first two blogs, the author notes that the Commission appear to have ‘cherry picked’ the evidence that supports the Regulation and has focused on complaints by larger technology companies rather than taking an impartial view of the situation. Furthermore, the IP Europe blogs present data indicating that SEP litigation and FRAND disputes are generally declining, another basis for questioning the need for the new Regulation.

Click here to read blog 1 and 2 from the series.

To raise awareness about the different forms of voluntary collaborations, particularly those related to technology transfer, IFPMA hosted a working lunch in Geneva in June.  

Several partners shared insights and experiences about their COVID-related manufacturing partnerships. The discussion touched on the types of bottlenecks that slowed the pandemic response – and how these can be tackled in the coming months. 

Particularly fascinating is the part of the session starting at minute 46 where the panel discussion with industry experts begins.

Click here to watch the video of the event

Innovation Council submitted these perspectives to the ITC investigation of COVID-19 Diagnostics and Therapeutics and Flexibilites under the TRIPS Agreement.

In this new paper from Bruegel, the authors explain the green subsidies in the US Inflation Reduction Act and recommend actions the EU might consider to respond to those subsidies. They explain why certain policy responses – like loosening state aid – might be counterproductive for the EU, and point out that existing EU green subsidies are quantitatively similar to those introduced in the IRA. Long paper, but the thorough analysis is clearly presented and worth reading. It even has a handy annex explaining WTO subsidies rules for those wanting to better understand why many consider the IRA to be WTO-inconsistent. Read more about this paper here.

The Commission adopted on November 30 a new EU Global Health Strategy to improve global health security and deliver better health for all in a changing world. The Strategy positions global health as an essential pillar of EU external policy, a critical sector geopolitically and central to EU strategic autonomy.

Click here to read more.

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.

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.

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.