The Ministry of Food and Drug Safety said on the 2nd that amendments to the Pharmaceutical Affairs Act, the Medical Devices Act, the Narcotics Control Act and the Cosmetics Act containing these provisions passed the National Assembly's plenary session on the 1st.
The revision of the Pharmaceutical Affairs Act establishes a legal basis for pharmaceutical companies to supply drugs free of charge to patients in need of rare disease treatments and for the Korea Orphan & Essential Drug Center to support such programs. The move brings programs that drugmakers have long run as a matter of practice within the bounds of the law.
Until now, there was legal uncertainty that the process of pharmaceutical companies supplying rare disease drugs free of charge through medical institutions could conflict with the Pharmaceutical Affairs Act's ban on providing economic benefits. With the amendment providing a clear legal basis for free supply for patient assistance purposes following set procedures, treatment access for rare disease patients is expected to improve. The ministry also expects that institutionalizing patient assistance programs will spur humanitarian support for patients who need rare disease drugs.
The Medical Devices Act amendment establishes a supply management system, including national-level designation and management of essential medical devices and the operation of a stable supply council. National essential medical devices are devices that are indispensable for health care but have no substitutes or cannot be stably supplied through market mechanisms alone, meaning a supply disruption could cause serious harm to public health.
The Narcotics Control Act will also be strengthened. Judicial police officers will be able to conduct narcotics tests when illegal use by narcotics handlers or employees is suspected, and punitive fines may be imposed for serious violations such as use for unintended purposes or illegal diversion. Such disciplinary actions may also be made public.
The Cosmetics Act adds a basis for measures to prevent consumer harm, such as halting sales of counterfeit cosmetics. It also creates a basis for designating a global cosmetics regulatory support center to help companies respond to export regulations.
An official at the ministry said, "We will continue to pursue institutional improvements that place public health and safety, including securing patients' right to treatment, as the top priority and create an environment free from the risks of narcotics abuse and misuse."
