Background

Formation of Taiwan Drug Relief Foundation for Drug Hazards (TDRF)

Any medicine intending for a cure might still have chances to cause severe adverse drug reactions on patients. Several events related to the adverse reactions caused by terbinafine and itraconazole broke out in 1997 in Taiwan. These events prompted the Department of Health of the Executive Yuan (now the Ministry of Health and Welfare,MOHW) in Taiwan to develop a humanistic program providing a timely relief to patients who suffered from adverse effects in 1998. This relief program reinforced the proper use of medicine while patients were subsidized if indeed adverse drug reactions occurred.

Drug relief program was launched by MOHW in two stages. Firstly, policy of drug relief program was declared on the 12th of October in 1998, and it was implemented on the 12th of January in 1999. Several key points drawn from the policy gave birth to the committee by which Clinical Pharmaceutical Association was commissioned to implement the policy during the first stage. Clinical Pharmaceutical Association formed two teams, Drug Relief Review Team and Relief Fund Management Team, embarking on tasks such as investigation of adverse drug reactions, fund raises and release of subsidy to approved applicants for drug hazards. Secondly, MOHW further pushed the policy to Legislative House to make Drug Relief Law. MOHW had made a great effort to obtain agreements among pharmaceutical industry and associations through numerous negotiations. Finally the concept was supported by legislators and consumers. Drug Relief Law was promulgated and announced by President of Taiwan R.O.C. on the 31st of May, 2000. It was enacted on the second of June, 2000. This law demonstrated the resolution of government to assure patients’ right subsidizing them in case of drug hazards occurred.

Drug Relief Law is comprised of 28 articles divided in 6 chapters. According to article 5, the authority shall set up a drug relief fund to finance the work of drug relief. And article 6 states: “the authority shall commission another organization to take charge of financial management and relief tasks. If a situation arises, a corporate foundation can be established for due purpose.” Considering Drug Relief a perpetual public welfare undertaking, MOHW decided to form a corporate foundation to compensate patients who suffer from drug hazards. As a result, Taiwan Drug Relief Foundation (TDRF) was created and dedicated to carry out Drug Relief Law. TDRF was registered on the 24th of September, 2001, and had grand opening on December 25th of the same year. TDRF now receives patients’ applications for drug relief, educates people on drug safety, collects relief fund, releases subsidy, and establishes databases for Pharmacovigilance.

 

Scope

TDRF was established by the Department of Health of the Executive Yuan（now the Ministry of Health and Welfare,MOHW） as a non-profit organization to carry out drug relief tasks, conduct researches, and investigate adverse effects on legal drugs. The premises of this organization are manifold. TDRF supports victims through timely subsidy. It protects patients’ rights when medicine is properly used, while the reputation of pharmaceutical companies, medical centers and hospitals is guarded. Drug Relief Law reinforces the proper use of medicines, which ultimately ensures patients’ safety and the quality of healthcare industry.
Post market drug safety has drawn more and more attention in pharmaceutical world nowadays; MOHW responded to the needs of pharmacovigilance on medicines, medical devices and food supplements, established four nationwide reporting systems:

  1. National Adverse Drug Reactions Reporting system (ADR),
  2. Medical Devices Reporting System,
  3. Medical Product Defect Reporting System,
  4. Dietary Supplement Non-expected Reaction Reporting System in Taiwan.

TDRF was commissioned to support the tasks of nationwide reporting for MOHW to monitor drug safety in global markets.

 

Mission

Our missions are following:

  1. Collection management of relief fund contributed from pharmaceutical companies including manufactures, and importers.
  2. Investigation of applications submitted by patients who might suffer from adverse drug reactions.
  3. Release of fund payment to approved applicants.
  4. Education for general public on drug relief program and adverse drug reactions.
  5. Conduction of projects related to post-market pharmacovigilance on medicines, medical devices, and food supplements.
  6. Management of databases for National ADR Reporting System, Medical Devices Reporting System, Medical Product Defect Reporting System and Dietary Supplement Non-expected Reactions Reporting System.
  7. Investigation of adverse events and future prevention proposals.