Biotech groups slam Malaysia, Canada and Korea in Special 301 comments
Trade associations Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization (BIO) have called for Malaysia to be placed on the US Trade Representative’s (USTR) watch list in its “2018 Special 301 Report”.
The USTR’s annually-published report reviews IP protection and enforcement abroad, and identifies challenges facing America’s innovative and creative industries in overseas markets.
In submissions to the USTR, both associations claimed that they and their members were alarmed by the recent actions of the Malaysian government and that Malaysia should be treated as a priority foreign country.
PhRMA noted that the government had approved what it is characterising as a “government-use” licence for a breakthrough innovative medicine.
While the associations didn’t name the drug or its manufacturer, it is believed that Gilead's Hepatitis C drug sofosbuvir is at issue.
According to PhRMA, the actions “undermine a core tenant of IP protection and, if unaddressed, could inspire other countries to advance similar compulsory licence schemes undermining vital IP”.
“This action could cause serious harm to a US manufacturer that was engaged in ongoing negotiations with the government of Malaysia on a voluntary licence at the time this compulsory licence was unilaterally issued,” said the submission.
BIO added that the actions constituted a “blatant disregard of patent rights protection” and that a government-use licence would “nullify patent rights in favour of providing marketing opportunities to local pharmaceutical companies”.
In its submission, BIO also noted concerns over the perceived lack of effective regulatory data protection in the country.
PhRMA also recommended Canada and Korea be listed as priority foreign countries.
On Canada, PhRMA said it was concerned about proposed regulatory changes to the current mandate of the Patented Medicine Prices Review Board from ensuring “non-excessive” prices to “affordable” prices.
“These proposed changes could have a serious negative impact on US biopharmaceutical companies operating in Canada, the availability of new medicines to Canadian patients, and the competitiveness of Canada for research-based pharmaceutical investment,” noted PhRMA.
According to the association, Korea’s drug pricing policies “severely devalue” US IP and the US should make clear that Korea’s pricing practices are inconsistent with its commitments under the US-Korea Free Trade Agreement.
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