PrEP Stymied in Europe: What's the Hold Up?
Europe is the birthplace of the smallpox vaccine and the Renaissance, among other treasures. So why can't this continent that has brought forth such cornerstones of public health and flourishing civilization deliver oral PrEP -- a mere pill a day to prevent HIV, which already exists and is being successfully implemented in several countries, including Brazil, Kenya, South Africa and the US.
To be fair, France has been rolling out daily oral PrEP (consisting of Truvada) for over a year and a handful of others -- Norway, Scotland, Belgium and Portugal -- recently committed to provision plans. But the majority of countries on the continent are still struggling to even start to take PrEP to scale -- even though there has been a 60 percent spike in HIV incidence in the past decade.
The delay isn't due to lack of demand or a framework for PrEP provision. The call for PrEP from civil society is loud and clear, evidenced by the do-it-yourself droves ordering PrEP over the internet, clinic hopping, pill sharing and/or smuggling PrEP drugs into countries where it's not available via the health system.
It's been more than a year since the European AIDS Clinical Society Guidelines recommended PrEP and Europe's regulatory authority (EMA) approved Truvada (emtricitabine and tenofovir) for PrEP. In England, the National Health Service argued that it didn't have the mandate to introduce PrEP programs, as HIV prevention was the responsibility of district health authorities. The English High Court ruled otherwise and clarified that NHS did indeed have the power to launch PrEP programs. Even policy makers are warming to the idea of PrEP as more data from countries where PrEP is becoming available come in, suggesting that PrEP is working as HIV prevention in real-world settings.
So what's the hold up? Many are pointing to the drug company Gilead, the patent holder of Truvada, the only PrEP drug licensed in Europe. Recently, Gilead obtained an extension of its Truvada patent in England, where the original copyright expires this year. The pharma giant is likely to keep prices high while facing no competition from generic manufacturers until 2021. That's almost four years in a country with 17 seroconversions a day.
As a response to Gilead's motion to postpone its patent expiry in England, several generic producers filed a lawsuit that was kicked up to the Court of Justice of the European Union. Now any legal decision will apply to all EU member states, not only England. "If the court finds in favour of the generic companies, the cost of PrEP could be accommodated within current budgets through the savings made in treatment costs," wrote UK clinician advocates Sheena McCormack and Marta Boffito in The Lancet.
In the meantime, some health systems have hit the pause button on piloting PrEP. England is one example where its PrEP implementation has been delayed largely due to the prohibitive costs of the branded Truvada drug. Gilead has refused to waive its patent even for pending implementation studies. A planned 10,000-participant trial was slated to have started early in the year, but recruitment is now unlikely to begin until July.
Similarly, in Italy, the Bologna Checkpoint -- a community-run rapid HIV and STI testing center -- was poised to begin its PrEP implementation project, but the launch was thwarted when Gilead declined to provide donated or even discounted Truvada. They were told the company would no longer support PrEP implementation pilots in Western countries. The Italians then approached Mylan, the makers of a generic form of Truvada licensed for treatment in Europe. At first the generic supplier -- a plaintiff in the case against Gilead -- was happy to do business with Checkpoint but then opted to wait until the lawsuit was settled in the hopes of acquiring full marketing authorization to supply the discounted drug. As of yet there is no scheduled court date for the generic companies v. Gilead.
Activist Giulio Corbelli, of the European AIDS Treatment Group, doesn't think Gilead is cynically strategizing to block PrEP access in Europe. Rather, he says, the company simply pursues its commercial interests, creating barriers to access in the process. "They are not negotiating with the competent national authorities to identify a route for selling the drug; they are not supporting any implementation projects with their drug; and they are doing whatever they can to prevent other companies' support of such projects," he points out.
In addition to protecting its Truvada PrEP monopoly in Europe, Gilead has another bottom-line business incentive to slow European scale-up efforts. The company has released a low-dose version of Truvada, known as F/TAF, for treatment. Gilead has just completed recruitment for a large-scale PrEP study that will compare its new drug F/TAF with Truvada, with results due in 2020. If F/TAF proves to be as effective as Truvada in reducing HIV risk, Gilead can bring this new formulation of the drug to the European market -- right in time to replace an extended expiration of the Truvada patent in 2021.
The PrEP in Europe Initiative (PEI) sent Gilead an open letter asking the company to surrender its Truvada Supplementary Protection Certificate (patent extension). However, it's not likely the company will cave based on its previous intransigence around its shamefully priced hepatitis C drugs. Short of a Gilead walk-back, activists are encouraging health ministries to advocate for an expedited court case to finally rule on the patent extension so generic companies could hopefully get the green light to provide an affordable form of Truvada as PrEP. Or there might just be an uprising, another historic feat Europeans are known for.
Cindra Feuer is senior program manager at AVAC.