USTR report criticises pharma policies in Japan, NZ, Turkey
US pharmaceutical and medical device industries have expressed concerns regarding the policies of several countries, according to the Office of the US Trade Representatives.
The USTR released its 2022 Special 301 Report yesterday, April 27, which looks at the adequacy and effectiveness of US trading partners’ protection and enforcement of IP rights.
USTR reviewed more than 100 trading partners for this year’s Special 301 Report and placed 27 of them on its watch list or priority watch list.
According to the report, pharma companies have identified problematic policies in countries including Australia, Brazil, Canada, China, Japan, Korea, New Zealand, Russia, and Turkey, on issues related to pharmaceutical innovation and market access.
Stakeholders have expressed concerns about delays by Australia in its implementation of the notification process as required, under Article 17.10.4(b) of the US-Australia Free Trade Agreement.
In October 2020, the Ministry of Health announced planned reforms, but they require legislative changes, which have yet to be introduced in Parliament.
According to the report, the US "will continue to engage with Australia as it introduces legislation to increase transparency and to promote the early resolution of potential pharmaceutical patent disputes".
The report noted that pharma companies “have long expressed concerns about Japan’s shortcomings” in terms of transparency, meaningful stakeholder input, and predictability regarding pricing and reimbursement policies for advanced medical devices and innovative pharmaceuticals.
It added that recent policy changes to the Price Maintenance Premium (PMP) appear to make it easier for Japanese companies to qualify for the premium as compared to non-Japanese companies, particularly those that qualify as small and medium-sized enterprises.
Other concerns raised by the report relate to a reported lack of meaningful stakeholder input in the development of a health technology assessment system, as well as a lack of transparency and predictability associated with Japan’s implementation in April 2021 of annual repricing for drug reimbursement, which applies to a larger-than-expected range of products.
The report also flags concerns about the policies and operation of New Zealand’s Pharmaceutical Management Agency (PHARMAC), including, among other things, a lack of transparency, fairness, and predictability of the PHARMAC pricing and reimbursement regime, as well as negative aspects of the overall climate for innovative medicines in New Zealand.
Turkey’s pharmaceutical manufacturing inspection process also drew criticism. The USTR has urged Turkey to build upon its recent accession to the Pharmaceutical Inspection Convention and Co-operation Scheme (PIC/S) and to recognise Good Manufacturing Practices certificates issued by any of the PIC/S members to improve regulatory timelines.
The report noted that: “The US seeks to establish or continue dialogues with trading partners to address these and other concerns and to encourage a common understanding on questions related to innovation and pricing in the pharmaceutical and medical device sectors.
“The US also looks forward to continuing its engagement with our trading partners to promote fair and transparent policies in these sectors."
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