Medicinal products for human use according to the definition under Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
Draft Act amending Act No 378/2007 on pharmaceuticals and on amendments to certain related acts (Pharmaceuticals Act), as amended, and Act No 48/1997
on public health insurance and on amendments to certain related acts, as amended
The purpose of the draft Act is to contribute to better availability of pharmaceuticals to Czech patients through a combination of interrelated measures:
- a mechanism for extreme cases where a shortage of a medicinal product is detected, such as provision for the possibility of importing and using a medicinal product even if some of the formal requirements, which do not affect the quality and safety of the medicinal product, have not been duly met (§ 11 of the attached draft),
- prevention of uncoordinated exports from the Czech Republic in the case of a predefined, identifiable and justifiable group of medicines, which should concern medicinal products that are covered by public health insurance and dispensed on prescription,
- introduction of an ‘emergency medicine ordering system’, which should be compulsorily set up and operated by every manufacturer of a medicine covered by public health insurance and dispensed on prescription (§ 33a to § 33c of the attached draft).
Manufacturers and marketing authorisation holders will assume responsibility for ensuring that supplies cover market needs, while they will continue to be free to compete.
The attached measure under the Act on public health insurance addresses situations where, in the interest of ensuring the availability of a medicinal product, the maximum price at which it can be marketed in the Czech Republic or the amount of reimbursement for the product from health insurance need to be changed for a limited period during which it is expected to be unavailable.
Keywords: medicinal products for human use, availability of medicinal products