The PrEP situation in Europe

European PrEP: a history

The PrEP in Europe Initiative was set up to fill a gap in campaigning and policy around HIV pre-exposure prophylaxis (PrEP) in Europe.

PrEP has been adopted in Europe much more slowly than in the USA. It is still only available from doctors through the health system in a few countries, notably France, Norway, Scotland, Belgium and Wales. In Belgium a small co-pay fee is required.

Timeline

November 2010

The iPrEx study demonstrates the effectiveness of PrEP for the first time.

July 2012

PrEP, in the form of once-daily tenofovir/emtricitabine (Truvada) is approved by the US Food and Drug Administration (FDA) for people at high risk of HIV.

May 2014

The US Centers for Disease Control and Prevention (CDC) recommend PrEP and issue detailed guidelines for its prescription.

November 2015

France becomes the second country in the world to offer PrEP via its healthcare system. It did this through a ‘temporary recommendation for use’ (RTU), which became permanent in April 2017.

July 2016

The European Medicines Agency (EMA), Europe’s equivalent of the FDA, finally approves PrEP, four years after the FDA. There has never been a four-year gap between US and European approval for any HIV drug used for treatment.

November 2016

A second European country, Norway, offers fully-reimbursed PrEP.

April 2017

Scotland announces it will introduce PrEP; the first people in Scotland actually start PrEP in July 2017.

May 2017

Belgium and Portugal announce they are about to offer PrEP free at point of demand or with all costs reimbursed.

September 2017

The German Association of HIV Pharmacists announced a scheme whereby people in need of PrEP could ask doctors to write a prescription for four weeks’ supply for €50, which would then be arranged by participating pharmacies.

Other countries are conducting, or about to start, demonstration or implementation trials of PrEP before they agree to pay for it through their health systems. England is due to start a large implementation trial; the Netherlands has conducted a  trial; and trials are planned in some countries in eastern and central Europe too. In Germany, a scheme is being launched whereby people in need of PrEP may obtain it at an affordable price from sympathetic doctors and pharmacies.

The other way people have accessed PrEP in Europe is through buying it online. Online pharmacies can supply drugs sourced from generic-drug manufacturers at lower prices than those paid for brand-name drugs. Generic tenofovir/emtricitabine is available online for about 10% of the cost of brand-name Truvada.

Advocacy groups in the UK such as I Want PrEP Now and PrEPster have publicised PrEP purchase and similar groups have done the same in other countries.

In most European countries, it is illegal to import generic drugs when patents are still in force; a few, including UK and Switzerland, allow a limited amount to be imported for personal use. There is more information on buying PrEP and regulations here.

Approximately 130,000 people in the US are now taking PrEP out of the 1.2 million likely candidates, according to the US CDC.

In contrast, in Europe just under 3000 people are currently receiving PrEP through the healthcare system in France and up to 150 in Norway. These figures will grow as other countries adopt PrEP but still lag way behind the USA.

Very approximately, at least 10,000 people may be purchasing PrEP, regularly or intermittently, for their own use in Europe. It is possible therefore that over 10,000-15,000 people in Europe are taking PrEP.

This means that in a region with more than twice the population of the US, less than one-tenth as many people are accessing PrEP, and most of them are doing it at their own expense. The number of likely candidates has not yet been estimated.

This is why we need a PrEP campaign for Europe.