Reported by Tu Hui-Rong
The Legislative Yuan passed the third reading of the patent linkage system, which will have a significant impact on the development of the pharmaceutical industry in Taiwan. As the industry is to face another NHI drug price adjustment this year, the pharmaceutical industry mobilized support for a “self-help measure”, which argues that the patent linkage system should only be implemented after signing the FTA with the US or after entering the CPTTP or similar agreements. Last Thursday (22nd), the industry secured enough signatures to pass the threshold for the submission of the proposal. The competent author will reply to the proposal before April 22.
Liu Shih-Ning of TrendForce, an industry analysis company, expressed that the implementation of the patent linkage system will delay the launch of generic drugs and make it more expensive. It will also increase the NHI spending and affect doctors’ and patients’ choices of drugs. Under severe price competition and the pressure of NHI drug price cut, small and medium enterprises (SME) are expected to face greater impact from the patent linkage system because of their smaller product portfolios.
Liu Shih-Ning expressed that the patent linkage system affects not only the generic manufacturers, but also the biotech industry. It also applies to non-NCE new drugs, such as drugs of new administration routes, new dosage forms, new indications, new therapeutic compounds or new doses. The generic manufacturers play a key role in financing the biotech industry in Taiwan through direct investment or venture capital fund. The patent linkage system will affect manufacturers’ capital flow, and, hence, have an impact on the biotech industry.
Fan Jin-Cai, President of Standard Chem & Pharma Co., expressed that the patent linkage system is a forward-looking policy; howeverf, corresponding measures should be in place, and the implementation has to be progressive.
The three major industrial associations of domestic drug manufacturers considered that this amendment of the Pharmaceutical Affairs Act gives an advantage to patentees. It encourages patentees to file lawsuits to stop the MOHW from issuing drug licenses. However, generic manufacturers are not able to obtain any substantial compensation if they win a lawsuit.
Therefore, the three major associations initiated a joint proposal, suggesting that the implementation of the patent linkage system should be after the signing of the FTA with the US or after entering the CPTTP or similar agreements. This campaign has drawn huge support to pass the threshold for submission. The competent authority will make an official reply to the proposal before April 22.
【2018-02-26/ Commercial Times】