Protecting Intellectual Property Rights and Patient Access in the Pharmaceutical Sector

Strengthening protection of intellectual property rights (IPR) is crucial to attracting investment in Taiwan’s pharmaceutical sector. In order to better protect IPR for innovative products, the Pharmaceutical Committee of the American Chamber of Commerce in Taipei recommends completing the legislative process for Patent Linkage and Data Exclusivity. Patent Linkage prevents regulatory authorization of generic medicines when there is already a relevant patent in existence. Data exclusivity refers to the protection of the clinical trial data submitted to regulatory agencies to prove the safety and efficacy of new drugs, as well as the prevention of generic drug manufacturers from utilizing this data in their own applications. Both Patent Linkage and Data Exclusivity strive to protect IPR.

“Currently, in the absence of a Patent Linkage mechanism, there is no effective way to prevent infringing drugs from entering the market while the original product is still under patent production. In addition, the existing Data Exclusivity coverage is limited, confined to new components of new drugs,” the Committee notes in its position paper. The Pharmaceutical Affairs Act amendments, which seek to implement a Patent Linkage mechanism and further enhance the existing provisions for Data Exclusivity, went through a first reading at the Legislative Yuan in 2016, and are currently awaiting second and third readings before being enacted into law. The Committee urges the government to include the amended Pharmaceutical Affairs Act in the list of priority legislation for the upcoming fall session of the Legislative Yuan.

In order to increase patient access to innovative new drugs, the Committee recommends shortening the regulatory and reimbursement approval timeline for new drugs and new indications. In medical terminology, an “indication” for a drug refers to the use of that drug for treating a specific disease. A drug that has been indicated for diabetes for instance, has been deemed a viable treatment for diabetes. Shortening the regulatory review and reimbursement approval timeline for new drugs and new indications would dramatically improve patients’ health outcomes. The Committee provides a series of recommendations to the National Health Insurance Administration of the Ministry of Health and Welfare (NHIA/MOHW) on how to increase the new-drug budget, and expedite the review process for new-drug and new-indication registration to guarantee patients receive timely solutions for their medical needs. The Committee recommends referring to the approved indication content from the U.S. or the EU. “Often the new drug or new indication receives approval in the U.S. or the EU while the Taiwan registration process is still underway. If there is no specific consideration related to ethnicity or geography, it should be appropriate to use the approved U.S./EU indication content,” the Committee notes.

Adopting Managed Entry Agreements (MEA) is another policy that would help ensure that Taiwan patients have timely access to innovative new drugs. MEA’s are contractual agreements between manufacturers and health care payers that are introduced when there is uncertainty regarding the pricing and reimbursement of new medicines. The Committee notes that MEAs bring major advantages such as better patient access to innovative treatments, reduction of uncertainty regarding effectiveness and cost-effectiveness of specific treatments, more flexibility in coverage decisions, and better control of budget impact, among others.

The Committee provides a three-phase approach for increasing the new-drug budget. In the short-term the Committee recommends allocating current NHI savings toward funding new-drug and new-indication reimbursement. In the Medium-term the Committee recommends the NHIA change their policy mindset and prioritize providing insurance coverage only to serious diseases, rather than covering an expansive range of minor ailments. In the long-term, the Committee recommends the NHIA calculate the total amount of new drugs that will be needed in the following year in order to accurately estimate the next year’s new-drug budget. Estimating the new-drug budget for the following year will allow the NHIA to provide a predictable new-drug reimbursement timeline to ensure that budgetary constraints do not delay patient access to innovative treatment.

The Committee also emphasizes the need to guarantee the overall strength and sustainability of Taiwan’s healthcare system. Increasing funding for Taiwan’s healthcare system and developing stable, transparent mechanisms for adjusting drug prices are key strategies for strengthening Taiwan’s medical-service environment.

To read the full Pharmaceutical position paper, click here.