Cost-Containment Mechanisms for Essential Medicines, Including Antiretrovirals, in China - Health Economics and Drugs Series No. 013: Compulsory licensing - practical aspects and procedures: Marketing approval

Cost-Containment Mechanisms for Essential Medicines, Including Antiretrovirals, in China - Health Economics and Drugs Series No. 013
(2003; 30 pages) [French] [Spanish]

Table of Contents

	Acknowledgements
	Terms of reference
	Introduction
		Cost-effective medicine selection
		Price information
		International open tendering
		Voluntary discount agreements
		Voluntary licensing
		Compulsory licensing
		Local state production
		Government price controls
		Reduction of import and other taxes for essential medicines, and rational dispensing practices
		Public investment in R & D for new medicines: A mid- to long-term strategy
	Background and experiences with voluntary agreements
	Country rights to be protected in voluntary agreements for reduction of prices of medicines
	Compulsory licensing - practical aspects and procedures
		Identify relevant patents
		Explore possible sources of supply based on local production
		Identify possible sources of importation of the required medicine
		Marketing approval
		Request for a compulsory licence
		Granting of the compulsory licence by the Patent Administration Department
		Negotiation with patent holder about fee
		Determination of fee by the Patent Administration Department
		Appeal
		Other considerations
	Concluding comments
	List of persons contacted
	Further reading

Marketing approval

Registration requirements may pose obstacles to the speedy distribution of needed medicines. While considering the issuance of a compulsory licence, steps should be taken to ensure that such obstacles do not exist or are overcome.

China has recently introduced an exclusivity period of protection for test data (Article 35 of the Implementing regulations of the Drug Administration Law) which would only apply to products containing new chemical entities.