PhRMA says EU, WTO, others are ‘weakening’ IP
Pharmaceutical industry consortium PhRMA has asked the Office of the US Trade Representative (USTR) to put the European Union, the World Trade Organization (WTO) and the UK on a watch list of trading partners that could “weaken” IP rights.
In a 269-page submission to the USTR, PhRMA urged the office that the European Union, World Health Organisation, UK, Japan, China and Russia should be placed on a list of countries pursuing “dangerous” policies that would harm protections granted by IP.
Front and centre of the submission are concerns over mounting support for the temporary COVID-19 vaccine patent waiver currently stalled at the WTO, as well as more localised legislation such as the EU IP incentives review.
The review, first introduced in 2018, proposes allowing companies to manufacture generics and biosimilars in Europe during the Supplementary Protection Certificates (SPCs) period and export to non-EU countries
PhRMA said that it was concerned that the SPC waiver could result in the “weakening of existing incentive mechanisms” for biopharmaceutical innovation, and create an “unlevel playing field” for transatlantic medicines and trade investment.
The submission also claims that the SPC waiver would be susceptible to abuses and may be copied by others, which could weaken “already-low” patent protection standards in certain jurisdictions.
“If a leading developed economy like the European Union bends the rules, others are sure to break them,” PhRMA claimed.
It also took issue with EU member states’ government pricing and reimbursement practices that “restrict availability” to certain drugs, inditing Austria, Greece, Ireland, Italy and others for engaging in these practices.
The full list of agencies and countries that PhRMA suggests should be placed on these watch lists can be found here.
COVID-19 waiver
PhRMA also criticised the Biden Administration’s pledge to back the temporary waiving of rights under the Trade-Related Aspects of Intellectual Property (TRIPS) Agreement for COVID-19 IP.
“This policy position constitutes a reversal of longstanding US policy under both Democratic and Republican administrations concerning the protection of American intellectual property rights,” PhRMA said.
The industry group has been among the most vocal critics of the waiver. Last year, it jointly released a five-step plan as an alternative to the waiver that promises to help provide more equitable access to COVID-19 vaccines that would avoid waiving IP rights.
The plan was met favourably by many IP lawyers, but faced its own criticisms, with some suggesting that, the five-steps “voluntary action” plan does not consider how many lower-income companies lack the leverage to effectively combat the virus.
UK
The UK was also targetted by the PhRMA over imposed restrictions on the valuation of drugs, delays in pursuing its goal to increase R&D expenditure, and proposed threats to IP from Brexit.
PhRMA said: “Subsequent to the UK exiting the EU, it is important that the UK maintain robust IP protections.
“[It] should seek to benefit from the opportunity to distinguish its innovation environment for the life sciences from the EU by enhancing incentives where the EU has unfortunately weakened its innovation framework.”
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