Pharmaceutical News
Law amendment to assure the supply of medicine and nutrients for rare diseases

Reported by Lee Jen-Yue

The Executive Yuan passed the draft amendment of the “Rare Disease Control and Orphan Drug Act” on the 21st.  The amendment stipulates that the MOHW shall assist healthcare providers and patients in accessing medicine and nutrients essential for their treatment.  The draft amendment also specifies that drug companies should continue the supply of drugs for rare diseases until the drug license expires.  Failing to comply with this regulation may lead to a fine of NT$100,000-500, 000.


In order to prevent any unnecessary losses of lives due to the inaccessibility or unaffordability of life-saving drugs for rare diseases, this amendment stipulates the MOHW’s responsibility to help healthcare providers and patients to obtain medicine and nutrients necessary for treating rare diseases.  Zheng Chung-Min, Deputy Minister of the MOHW, expressed that the amendment clearly specifies the services which should be provided by the central competent health authority.  Zheng said: “The central competent authority should send professionals to visit healthcare providers, reward associations and organizations contributing to the prevention of rare diseases, and provide assistance for patients with rare diseases in seeking education, employment and care.”


The draft amendment also regulates that drug companies should continue the supply of drugs for rare diseases during the validity period of a drug license except for events of force majeure. Drug companies failing to comply with this regulation will be subject to a fine of NT$100,000-500,000. This regulation is to protect patients’ medication rights, said the Executive Yuan.


Furthermore, the government should set a budget to subsidize the costs of supportive and palliative care and essential nutrients which are not reimbursed by the NHI.    The MOHW may include drugs for rare diseases in the NHI benefit scheme on a case-by-case basis.


【2014-08-21 / BCC News】