Taiwan's regenerative medicine prospects are poised to flourish. The draft of the Regenerative Medicine Act and the Regenerative Medical Products Act (dubbed 'Regenerative medicine twin acts') has been sent to the Legislative Yuan for an article-by-article review, which has attracted the attention of the public. According to Chih-Liang Yang (楊志良), the former official in charge of Health, said that the acts do not take the global GMP standard into account, but the industry wants to be aligned with the international standard, and the United States, the European Union and Japan all adopt the GMP standard, calling on the government to impose strict requirements on cell processing in this regard.
On the 20th, PwC Taiwan and Taiwan Society of Regulatory Affairs for Medical Products (TsRAP) held a press conference on the twin acts and trends on regenerative medicine, inviting experts to discuss legal perspectives on the excellent environment for the development of Taiwan's regenerative medicine industry from their point of view.
Yang said that Taiwan's regenerative medicine industry will be one of the most important industries for future development, however, the Executive Yuan's draft of the regenerative medicine act lacks global GMP standards as a benchmark. However, the US, EU and Japan have all adopted GMP, CGMP or PIC/S:GMP for the implementation of cell processing in regenerative medicine. The government is urged to set strict requirements for cellular operations in regenerative medicine, and the regeneration law should establish appropriate management systems for the industry as a whole, biotechnology companies and healthcare facilities respectively.
The Honorary President of TsRAP, Mei-ling Hsiao (蕭美玲), said that regenerative medicine products are biological preparations and require a complete drug management system and regulations, and stressed that medical institutions should implement operations in accordance with the PIC/S GMP, GTP and GMP in order to protect patients' rights and To improve the quality of regenerative medicine in Taiwan.
Prof. Thomas Chen (陳鋕雄), Dean of NYCU School of Law, stressed that the Executive Yuan's version of the draft Regenerative Medicine Act does not stipulate that global GMP standards must be used as the legislative standard in the production process of regenerative medicine products, which makes them worry about the safety issue. Compared to the Council of Agriculture's requirement of international GMP for animal drugs, the production standard of regenerative medical products lacks globally recognised norms, and more attention should be paid to how to protect the rights of Taiwanese people.
Chen stressed that in order to ensure the sustainable development of the regenerative medicine industry in Taiwan, the government must take measures to set strict production and management standards and implement global GMP standards, so as to protect the rights and safety of the Taiwanese people when using regenerative medicine products. The government is strongly urged to take into account international standards when enacting the regenerative medicine law and to strengthen the supervision and management of the production, manufacture, sale and regulation of regenerative medicine products. This is a sign of responsibility towards the health and safety of the people of Taiwan, and a necessary measure to protect the development of the regenerative medicine industry in Taiwan.
"Although the establishment of companies of this kind is helpful for scale and institutionalisation, attention needs to be paid to the issue of tax incentives already enjoyed by non-profit healthcare groups," said Jinrong Lin (林金榮), partner at PwC Taiwan.
Article 11(5) of the Draft Law stipulates that a medical institution with cell processing on its own and has reached a certain scale may, upon approval by the authority, initiate the establishment of a company specialising in cell processing in accordance with Article 128(3)(3) of the Company Law. The establishment of a biomedical company will also require consideration of a mechanism to maintain the fairness of the taxation system.
According to a report related to regenerative medicine published by PwC Taiwan, the average annual compound growth rate of the global regenerative medicine market from 2020 to 2030 is expected to reach 13.99%, with the market size reaching US$87.03 billion. However, as the legislation involves the implementation of good quality regulations for cell processing, the protection of patients' rights and workforces between non-profit medical institutions and profit-making businesses, experts call on the authorities to carefully assess the views of all sectors and make decisions that will benefit the public, the cell processing and the industry.
