World Drug Regulatory Authorities Meet In Brazil; Biosimilars In Focus

Drug regulatory authorities are meeting this week in Rio de Janeiro, Brazil to discuss global regulatory issues such as vaccine regulation, falsified products, and pharmacovigilance. A “pre-conference” focused on biosimilars, with civil society warning on barriers to access to those products.

The 16th International Conference of Drug and Regulatory Authorities (ICDRA) is taking place from 26-29 August in Rio.

The aim of the conference is to provide drug regulatory authorities of the World Health Organization member states with a forum to share information and strengthen collaboration, according to the WHO.

A pre-conference titled, “Ensuring Quality and Safety of Biosimilars for Patients Worldwide” was held on 24-25 August, open to drug regulators, pharmaceutical industry, academia, non-governmental and international organisations, according to the ICDRA website. The conference itself, however, is restricted to government officials and regulators.

The ICDRA programme includes plenary sessions and workshops, such as: Best Practices in Pharmacovigilance; How to ensure the safety of traditional and complementary medicines in national healthcare systems; Challenges of vaccines regulation and safety monitoring; Preventing and reducing the risk to public health from SSFFC (substandard/spurious/falsely-labelled/falsified/counterfeit) medical products; Biosimilars; and Strengthening regulatory systems for medical products.

According to a definition provided by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), biotherapeutics “are very complex molecules made in living organisms by genetically engineering DNA.”

“Regulatory authorities are continually faced with new issues,” according to the WHO, including globalisation, the extension of free trade, improvement and sophistication of products which increase the demand on regulatory systems, and extensive use of the internet.

For the IFPMA, “biotherapeutics are the new generation of medical treatment that is making a genuine difference in people’s lives who are suffering from cancer, diabetes, rheumatoid arthritis, multiple sclerosis, hepatitis C, and chronic renal failure.”

“Access to biotherapeutic products, including biosimilars, and ensuring their quality, safety and efficacy will be important challenges in the future,” IFPMA stated, underlining the importance of pharmacovigilance systems.

Civil Society: Keep Prices Within Reach

A long list of civil society groups issued a statement on the pre-conference and the conference itself. In their statement, circulated on the Knowledge Ecology International ip-health listserv, the groups recognise the potential of biotherapeutic products to address healthcare needs but warned about high prices of such products. The groups said those high prices prevent millions of people from getting access to those products and are preventing governments from including biotherapeutic products in public health programmes in a sustainable manner.

“The promotion of biotherapeutic products should not be driven by market interests,” they said. Two factors act as barriers to biotherapeutic products, the group said, one of which is intellectual property rights and a stringent regulatory framework. The group also suggests that the WHO guidelines are based on the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) standards for the regulation of biotherapeutic products, which according to them is “an exclusive club of originator companies and drug regulatory authorities of US [United States], EU [European Union] and Japan.”

The group called upon governments and regulatory authorities “to establish regulatory frameworks that facilitate access to affordable, safe and efficacious biotherapeutic products.” “Regulation cannot pose a new barrier to competition and access…” they said, mentioning the World Health Assembly resolution (67.21) on access to biotherapeutic products adopted in May 2014 .