Formosa Transnational - Taiwan
In an abrupt u-turn, the Taiwanese Food and Drug Administration (FDA) has gone from excluding biosimilars from the patent linkage system in November 2018 to including them in January 2019. The disputes that arose as a result of the exclusion still cannot be resolved, even though the FDA said that it had considered the impact on local companies as most of them are generic or biosimilar drug manufacturers.
When the Amendment of the Pharmaceutical Affairs Act was first passed in December 2017, the FDA stated that biosimilars would be included in the system. However, it then used term ‘generic drug’ in the provisions (biosimilar is the generic version of a protein drug). The FDA stated that the inclusion of biosimilars would be clarified in the Enforcement Rules and Guidelines to Patent Linkage (for further information, please see Patent linkage system passed by Legislative Yuan). However, this raises the issue of whether doing so would violate the legal reservations to extend the system to biosimilars in the guidelines.
The Ministry of Health and Welfare and the Ministry of Economic Affairs held a public meeting on 16 May, in which the latter explained that the Amendment of the Pharmaceutical Affairs Act (ie, the act that introduced the patent linkage system) did intend to include biosimilars. The political deputy minister representing the Ministry of Economic Affairs clarified that:
the current Pharmaceutical Affair Act does not distinguish chemical drugs from protein drugs. Both of them are collectively mentioned as ’new drug’ in the provision. Thus, since a protein drug, as a kind of new drug, has to list relevant patents, the biosimilar shall be no doubt part of the system.
In a public meeting, the two ministries announced that supporting measures would be put in place to compensate for the impact on the biosimilars industry. They also stated that several seminars and training sections would be arranged to educate the industry about the system.
However, as of yet, no such supporting measures have been announced for biosimilars, nor has a clear date been given for the implementation of the system. Despite this, the minister of health and welfare revealed that it is considering adding in a transitional clause to exempt the biosimilars that have already received official approval for clinical trials in the period that the linkage system is being implemented. This was officially announced by the Ministry of Health and Welfare on 1 July 2019. It is possible that generic/biosimilar manufacturers would accelerate production in the following years.
Despite these disputes, it is apparent that the government has made its decision to implement the system soon. Instead of trying to prevent its implementation, people are now focusing on compensation. For example, as a participant in the public meeting asked, “if the TFDA insists on including biosimilars in the patent linkage system, what is the government planning to provide to compensate the local industry?”