Biosimilars agreement critical step towards universal health care

FULL access to medicines is hampered by a variety of factors.

According to the World Health Organisation (WHO), two important barriers are high prices and regulatory issues such as long lag times in taking medicines to the market.

To address these issues, WHO director-general Dr Tedros Ghebreyesus, and International Generic and Biosimilar Medicines Association (IGBA) chairperson Jim Keon signed a memorandum of understanding which will facilitate co-operation between the two organisations to reduce the burden of clinical trials for biosimilars, speeding up registration and increasing access.

The WHO said the agreement was an important step in its drive towards universal health coverage.

“WHO is an active supporter of expanding use of generic medicines: the vast majority of the products in the WHO essential medicines list are generic.

“WHO’s prequalification programme – which assesses the quality of priority medicines supplied by UN agencies and other organisations in low-income countries – has prioritised generic medicines as a way to treat more people with the funds available; around 70% of the medicines it prequalifies are generic.

“A recent independent study by McKinsey estimated WHO prequalification saves the world up to $590 million (more than R8.6 billion) every year. Every $1 invested in WHO prequalification has a return in terms of savings of between $30 to $40 (R438 to R584),” the WHO said.

The IGBA earlier this year released a revised report called “Trade Principles: Generic and Biosimilar Medicines”, that highlighted five key areas of trade agreements where decisions made can have a profound impact on the trade in generic and biosimilar medicines.

These were regulatory approaches, technical barriers to trade, intellectual property, competition/anti-trust safeguards and incentives.

“While trade agreements should be focused on facilitating trade between countries, all too often we see agreements that erect new barriers to the trade for generic and biosimilar medicines manufacturers and hinder access to affordable medicines.

“The removal of such barriers would reduce costs for the development of generic and biosimilar medicines and ensure that such products can be traded freely and enter markets without delay,” Keon said.