Malaysia affirmed today that it will set a five-year limit on data exclusivity for biologics under the Trans Pacific Partnership (TPP) agreement, amid concerns of US pressure on prospective partners to adopt an eight-year time frame.
International Trade and Industry Minister Datuk Seri Mustapa Mohamed said the country has not budged from its position on the class of medicine that includes new cancer treatments, even as the recently released TPP text included provisions for an eight-year data exclusivity period.
“For Malaysia, it is five years,” he said at a news conference here.
Opposition lawmakers criticised Mustapa earlier today for previously saying that data exclusivity for drugs in the TPP was five years, whereas the released text for the Pacific free trade treaty set an eight-year period.
Last week, deputy US Trade Representative Robert Holleyman said in Australia that TPP member countries need to provide market protection for the biologic medicines sector by having either a minimum eight-year data protection period, or a five-year period with sufficient measures that can deliver a “comparable outcome”.
Holleyman said the measures could include regulatory procedures or other administrative actions that would provide “effective market protection that are strong and meaningful”.
The biologics industry produces medicines based on natural sources and covers a wide spectrum of treatment such as vaccines, gene therapy and chronic illnesses.
Meanwhile, Mustapa said today that the cost-benefit analyses on the TPP commissioned by Putrajaya should be ready within 10 days, but it will only be released publicly after it is tabled before the federal Cabinet.
He also said the TPP will likely be tabled in Parliament in the last two weeks of January.
Putrajaya will organise town hall sessions in December and January to explain the TPP, with both sessions open to the public, Mustapa added.(JOSEPH SIPALAN)
Link: https://sg.news.yahoo.com/minister-malaysia-firm-five-data-protection-biologics-under-070200107.html
20
