HTB

Generic PrEP in France and Scotland challenges access across the UK

Simon Collins, HIV i-Base

This week, two interesting developments were reported in relation to generic tenofovir disoproxil/emtricitabine in the UK.

Firstly, the French HIV community organisation AIDES, reported that the French courts had not supported extending the patent for tenofovir disoproxil fumerate (TDF)/emtricitabine(FTC), coformulated as Truvada and manufactured by Gilead.

Although a generic formulation of TDF/FTC has been available in France since July 2017, this was challenged by Gilead. In addition to the challenge not being upheld, Gilead had to pay costs to the generic manufacturer Mylan. Thirty tablets of TDF/FTC is currently priced at approximately 180 euros for the generic compared to 406 euros for Truvada.

Secondly, on Friday 8 September, HIV Scotland announced that NHS Scotland would be using generic formulations for both ART and PrEP. [2, 3]

The tender for use as HIV treatment will use tenofovir disoproxil phosphate/FTC, manufactured by Zentiva, while the tender for use as PrEP will be with tenofovir disoproxil succinate/FTC, manufactured by Dr Reddy’s.

Although no details were published on the prices, the new contracts will start from 1 November 2017 and will replace use of the current patent formulation TDF/FTC manufactured by Gilead.

This is important because in September 2016, the European Medicines Agency (EMA) approved three generic formulations of TDF/FTC that use a different base salt for tenofovir. [4]

However, in January 2017, when the patent for TDF/FTC was challenged in the courts in England and Wales, a decision on the patent was referred to the European Court, making the timeline for access to more affordable versions uncertain. [5]

The precedents shown in France and Scotland, challenge NHS England to proactively move to generic formulations, if the price differences continue to be so high. This would also challenge the decision by NHS England to defer providing PrEP until after results of the upcoming IMPACT study. [6, 7]

comment

The issue of drug procurement and pricing is complex but it is difficult to see how different patents should apply within Europe, and especially not within the UK.

References

  1. AIDES. GÉNÉRIQUEURS 1 – GILEAD 0. (07 September 2017.
    http://www.aides.org/communique/generiqueurs-1-gilead-0
  2. HIV Scotland. Generic PrEP now available on NHS. (8 September 2017).
    http://www.hivscotland.com/news-and-events/latest-news/article/generic-prep-now-available-on-nhs
  3. NHS Scotland National Procurement. Tenofovir disoproxil/emtricitabine. (8 September 2017).
    https://www.publiccontractsscotland.gov.uk/search/show/search_view.aspx?ID=SEP294859
  4. EMA Committee for Medicinal Products for Human Use (CHMP). Emtricitabine/tenofovir disoproxil Zentiva, Summary of opinion (initial authorisation). EMA/CHMP/596525/2016. (15 September 2016).
    http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004137/WC500212887.pdf (PDF)
  5. England and Wales High Court (Patents Court) Decisions. Teva UK Ltd & Ors v Gilead Sciences Inc [2017] EWHC 13 (Pat) (13 January 2017).
    http://www.bailii.org/ew/cases/EWHC/Patents/2017/13.html
  6. Prepster. The PrEP IMPACT trial.
    http://prepster.info/impact
  7. The PrEP IMPACT trial. A pragmatic health technology assessment of PrEP and implementation.
    prepimpacttrial.org.uk 

Links to other websites are current at date of posting but not maintained.