Paris, 30 August 2013

Prescrire's response to the EMA consultation on drug brand names

> Click here to download Prescrire's response (pdf, 117 Ko)

Summary

• Prescrire has examined the proposed revision of the European Medicines Agency (EMA) guideline on the acceptability of brand names for drugs processed through the centralised procedure (revision 6) released for public consultation in June 2013.
• Since the EMA adopted the previous version of the guideline in 2007, the North American drug regulatory agencies have improved their methodology for detecting the risk of confusion between brand names. The EMA has not: this revision provides very little progress in terms of preventing the risk of confusion between drugs.
• This revision will primarily help pharmaceutical companies to protect trademarks and manage their brand: no effort has been made to encourage a naming system that clearly states the drug’s international nonproprietary name (INN-based naming); trademarks can be expanded indefinitely by adding qualifiers, which will notably encourage the development of "umbrella" ranges; previously authorised names can be recycled; greater differentiation is required between "biosimilars"; etc.
• Instead of working to protect the integrity of the INN system and its common stems, the EMA proposes ending systematic consultation with the WHO INN Programme. Yet collaboration between these organisations should actually be strengthened, notably to tackle the issues of "biosimilars" and modified INNs.
• Prescrire’s response to this proposed EMA revision includes ten concrete proposals that would shift the focus of the guideline onto preventing confusion between brand names:
  1. Improve the methodology used in Europe to assess the risk of confusion between commercial names before market introduction.
  2. Broaden the search for similarity between brand names to include all the drugs marketed within the European Union.
  3. Provide access to basic information about every drug marketed in the European Union.
  4. Publish the list of drug names prone to confusion.
  5. Strongly encourage the use of INN-based drug names.
  6. Refuse to allow the proliferation of “umbrella” branded drugs.
  7. Revert to more prudent use of abbreviations and suffixes.
  8. Refuse to allow the recycling of previously used brand names.
  9. Cooperate effectively with the WHO INN Programme.
  10. Involve patients and independent medication error-reporting programmes in the search for improvement.

©Prescrire August 2013

> Click here to download Prescrire's response (pdf, 117 Ko)