Healthy Skepticism Library item: 9251

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Madden EA.
The interaction between intellectual property and drug regulatory systems: global perspectives.
IDrugs 2007 Feb; 10:(2):116-20
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17285464&query_hl=6&itool=pubmed_DocSum

Abstract:

Regulatory compliance in the development, production and sale of new drugs accounts for the largest single expense in bringing a drug product to market. To justify developmental and regulatory compliance costs, drug innovators turn to the intellectual property (IP) system to provide a means for securing returns on investment. Because the drug regulatory system in most countries operates in isolation of the IP system, one of the greatest challenges facing the pharmaceutical industry is the extent to which IP rights can be managed against an independent drug regulatory system. Many regulatory bodies in developed countries have sought to ensure a compromise between the rights of generic companies and IP owners by including safeguards in the regulatory framework, such as patent linking and data protection; however, these efforts are yet to be applied in some of the biggest potential drug markets in emerging economies.

Keywords:
Publication Types: Review MeSH Terms: Animals Computer Security Drug Industry/economics Drug Industry/trends* Drugs, Generic Humans Intellectual Property* Legislation, Drug/trends* Patents Substances: Drugs, Generic