Contract Manufacturing of Medicines

Taking advantage of liberal regulations under the current world trade regime that permit the separation of manufacturing from marketing, many pharmaceutical companies (like other companies) outsource the actual manufacture of their products. However, because the quality of medicines is crucial to public health, the pharmaceutical industry is perhaps the most regulated of all industries. In most countries medicines are controlled prior to their marketing, and their manufacture is carried out under strict supervision. Necessarily, numerous international initiatives have led to elaboration of standards relating to the manufacture and marketing of medicines. These standards impose stringent rules on all parties to pharmaceutical manufacturing contracts.

This very useful book provides a comprehensive global guide to the legal issues and procedures involved in outsourcing the manufacture of medicines. It describes the legal requirements relating to the manufacture and distribution of medicines, emphasising the impact of regulatory supervision on the rights and obligations of persons who outsource manufacturing of medicines and on those who provide the manufacturing services. The author provides detailed coverage of such pertinent topics as the following:

• definition of ‘medicine’ in different jurisdictions;

• categories of medicines;

• manufacturing and importation regulation in numerous jurisdictions worldwide;

• inspection regimes;

• good manufacturing practice (GMP);

• marketing authorization;

• manufacturing documentation;

• complaints and product recall;

• liability insurance;

• protection of trade secrets;

• data exclusivity and data protection;

• deficiencies and delays; and

• recognition and enforcement of judgements.

A significant part of the book is devoted to cross-border problems arising from such matters as conflict of laws or taxation.

Indispensable to counsel for pharmaceutical companies of any size, Contract Manufacturing of Medicines will also be of great value to practitioners and academics concerned with international trade for its precise, in-depth delineation of the inner workings of a complex and highly significant trade regime.