Politics

In this section you find information on policy and legal aspects surrounding pharmacogenetics.

Pharmacogenetics falls under rules for research on human subjects and genetic research (including regulations concerning the use of biobanks), but there are also distinctive guidelines.

• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use - ICH started the work by issuing Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories. This directive defines, among other things, the terminology of pharmacogenetics (for example, concepts around samples and information, such as identified, coded, double coded, anonymized, etc).
   
• EMEA, the principal European Medicines Agency,  followed with a Note for guidance on definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories.
  
  EMEA has also provided
  • a Reflection paper on the use of pharmacogenetics in the pharmacokinetic evaluation of medicinal products
     
  • a Reflection Paper on Pharmacogenomic Samples, Testing and Data Handling
     
  • a Guideline on Pharmacogenetics Briefing Meeting
     
  • patient information in Understanding the terminology used in pharmacogenetics.

Many organizations have presented their own statements:

• Council for International Organizations of Medical Sciences - Pharmacogenetics. Towards improving treatment with medicines
   
• Human Genome Organisation- HUGO Statement on Pharmacogenomics (PGx): Solidarity, Equity and Governance. This directive emphasizes the importance that research be guided by a concern for equity rather than solely for financial interests. It also articulates the importance of developing good governance practices so that research is carried out in an effective manner and in the best interests of the community. 
   
• European Federation of Pharmaceutical Industries and Associations (EFPIA): Pharmacogenetics in Medicinal Product Research and Development, Positon Paper. 
   
• See also Elements of informed consent for pharmacogenetic research; perspective of the pharmacogenetics working group (PWG). PWG is a voluntary association of pharmaceutical companies involved in clinical drug trials and genotyping whose goal is to advance the understanding and development of pharmacogenetics by addressing non-competitive ethical, regulatory, and legal issues.

• Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects (World Medical Association)
   

Source: modified from CODEX- rules & guidelines for research