EMA overcomes its own prejudice to approve PrEP in Europe: four years too late

On 22 July 2016, the European Medicines Agency (EMA) overcame their own organisational blocks and finally recommended granting authorisation for TDF/FTC to be used as PrEP in the European Union (EU).

This has taken four years since the FDA approved PrEP in the US. The delay is directly due to inappropriate actions from the European agency for which no-one has yet formally taken responsibility.

The recommendation for approval (by the Committee for Medicinal Products for Human Use – CHMP) is based on the same clinical evidence that was used to approve PrEP in the US in July 2012 – iPrEX and the Partners PrEP study.

Following US approval, instead of allowing a similar application for EU access, the EMA took it upon itself to decide that PrEP was not for Europe – despite community pressure to enable access. Instead, a committee, acting without authority or transparency, decided to block access to the latest prevention options to people in the EU.

Their rational was an erroneous belief that there would be little demand for PrEP and a misguided concern that people using PrEP might use fewer condoms – the outcome that PrEP is specifically designed to protect against.

These concerns are not the remit for a scientific agency charged with evaluating efficacy and safety of medicines. To refute this, the EMA should provide examples of when statins, fibrates or other medicines for cardiovascular health have been withheld due to the committee concerns that people might continue to smoke cigarettes, enjoy pastries or exercise slightly less than recommended guidelines.

In this case the EMA took inappropriate moral – rather than scientific – decisions to block access to the most advanced option for protection against HIV infection.

In doing this they disproportionately affected marginalised populations including gay men, people who inject drugs, sex workers and migrant communities.

Comment

Recommendations by the CHMP need to be formally adopted by the EU, after which, as with all medicines, each member country negotiates access, price and reimbursement.

The EMA delays played a role in the tens of thousands of new HIV infections that occurred since 2012 – and yet no-one from the EMA has acknowledged this lack of transparency in the approval process or taken personal responsibility for these decisions.