NEW DELHI : Several civil society organisations have urged the World Health Organization (WHO) to facilitate access to new biologic medicines and have called for updating of the WHO guidelines on similar biotherapeutic products.
In a letter to Prof. Klaus Cichutek, Chairperson, Expert Committee on Biologic Standardization, WHO, the organisations and patient groups stated, “We would like to reiterate our request to the WHO's Expert Committee on Biological Standardization to take the opportunity at the upcoming meeting to examine the scientific evidence behind the insistence of comparative head to head clinical trials under WHO’s Guidelines on Evaluation of Similar Biotherapeutic Products (SBP Guidelines) and update those accordingly. We also request you to provide reasons backed by verifiable evidence for your decision.”
While access to essential medicines is an integral part of universal healthcare, the financial hardships associated with high prices for some health processes and the inequitable access within and among the Member States impede progress in achieving Universal Healthcare.
Failure of the ECBS and the WHO Secretariat to update the Guidelines according to the latest scientific evidence compromises access to affordable essential biotherapeutic products and therefore it is a limitation to the full realization of the right to health, the letter stated.
The high prices are a reflection of protected monopolies in the biotech sector. Unlike in the case of generic equivalents of small molecule originator drugs, there is no effective competition in the market for BTPs even in situations where the patents of the originator molecules have expired. Beyond the technological or intellectual property barriers, regulatory challenges are the main reason for the lack of competition and therefore high prices, it said.