KEI Europe comments on the EU Pharmaceuticals roadmap
07 July 2020
i) The COVID-19 response
- COVID-19 Technology Access Pool (C-TAP)
Ensuring universal access to COVID-19 health technologies requires reforms of incentive systems, international cooperation, solidarity and deep technology transfer to facilitate competitive supply.
In the COVID-19 response, the European Union should mandate deep technology transfer for any effective vaccines, therapeutics or diagnostic tests, as well as rights in any test data needed to register products.
We request the European Union (EU) join the World Health Organization’s COVID-19 Technology Access Pool (C-TAP).
As part of the EU’s commitment to solidarity and deep technology transfer in the COVID-19 response, we request you to:
- License any potential vaccine, treatment, diagnostic, or other health technology (funded by the European Union or the European Commission) to the Medicines Patent Pool;
- Provide transparency around the publication of all clinical trial results;
- For all trials used to obtain regulatory approval, provide information on the costs, including public sector subsidies.
Assignments of intellectual property rights of COVID-19 technologies to WHO C-TAP should include existing and future rights in patented inventions and designs, regulatory test data, know-how, cell lines, copyrights and blueprints for manufacturing vaccines, diagnostic tests, devices, or therapeutics.
B. Article 31 bis of the TRIPS Agreement
The European Commission should reverse an earlier decision to voluntarily opt-out of World Trade Organization (WTO) rules to enable WTO members to import drugs, vaccines or diagnostic tests manufactured under a compulsory license in another country. Commissioner Phil Hogan’s response to MEP Bernd Lange in relation to Article 31bis was encouraging.
“The Commission is monitoring the situation carefully, in close contact with Member States, and it will not hesitate to take the necessary action if the need arises, also as regards the EU’s non-importer status under Article 31 bis of the TRIPS Agreement.”
ii) Cell and gene-therapies
The European Commission should take specific actions and refine cost saving initiatives that avoid rationing of treatments.
The EU needs to delink R&D incentives from the grant of monopolies and the price of products or services.
The Commission should conduct a feasibility study to evaluate the design, cost, feasibility and efficacy of market entry rewards as the alternative incentive for development of new cell and gene therapies.
The European Patent Office (EPO) should use the available policy space under the WTO TRIPS Agreement and the provisions of the European Patent Convention (EPC) to reject patent applications claiming CAR T methods of treatment, and educate policy makers on the alternative of market entry rewards as the incentive.
The Commission should create a working group to examine the implications of Article 27.3(a) of the WTO TRIPS Agreement on the patentability of gene and cell-based therapies when treatment can be described as a service or a medical procedure, rather than a product. The working group should explore if certain cell and gene-based treatments are, in fact, exempt from patentability when a country has an exception that mirrors Article 27.3(a) of the TRIPS Agreement.
The European Medicines Agency should not have to define cell and gene therapies as products to justify its regulatory activities.