Those working in HIV and pharmaceuticals say a ‘no deal’ Brexit will hit the supply of new HIV drugs to the UK.
The clock is now ticking down on the UK’s planned departure of the European Union following the 2016 referendum. The country departs the EU on 29 March 2019.
With no negotiated agreement between the UK and EU, a ‘no deal’ Brexit remains a possibility. This means the UK leaves the EU with no trade agreements in place.
The Government has already indicated healthcare as an area that may be affected. In particular, the flow of medicines in and out of the country. Pharmaceuticals are subject to many of the same trade agreements as other products.
Impact on how quickly new drugs come to the UK
Beyond the as-yet undecided trade agreements, the concerns around HIV medication are two-fold.
There are just over 100,000 people living with HIV in the UK. Over 95% of them are on antiretroviral therapy (ART).
But they’re not all on the same drugs. Currently, there are around two dozen medications approved in the UK for people with HIV.
These drugs keep viral loads suppressed. In turn, this keeps people with HIV healthy and stops them from passing on the virus. However, the medications are not without potential side effects. Long-term use can impact on particular body organs, such as the heart and kidneys.
New drugs are constantly being developed, often in the US. After approval by the US Federal Drugs Administration (FDA), big pharma companies then look abroad. Gaining approval in further territories allows them to sell the drugs worldwide.
The importance of the relationship between the EMA and the MHRA
The UK is currently high up the list of countries that are next in line to receive new treatment. This is partly because the UK is a member of the European Medicines Agency (EMA).
Another reason is that, until Brexit, the EMA would often turn to the MHRA (Medicines and Healthcare products Regulatory Agency) in the UK to review new drugs. Both organizations are based in London.
However, last November, the EMA announced it was relocating to Amsterdam because of Brexit. The UK will cease to be part of the EMA when it leaves the EU on 29 March 2019.
The MHRA has now fallen to the bottom of the EMA’s chosen list of reviewers. Therefore, post-Brexit, new drugs could find themselves approved for use in the EU first, before the UK.
‘The risk of the UK getting bumped back in the queue for introductions of new drugs is very real,’ says Mark Dayan, Policy & Public Affairs Analyst, Nuffield Trust.
‘The Medical Research Council has estimated that Switzerland, which is not part of the EU system, gets access to new medicines 157 days later on average than we do as EU members.
‘Recognising this among other problems with leaving the EU system, the Government has said they actually want us to stay part of [the EMA]. But it’s not at all clear that the EU is willing to play ball.
‘They tend to insist that the UK must be either in the whole single market, or none of it.’
What do pharmaceutical companies in the UK think?
Maintaining the MHRA’s central role is paramount for the The Association of the British Pharmaceutical Industry (ABPI). A spokesperson told GSN: ‘Good co-operation between the EMA and MHRA is essential after Brexit … to deliver proportionate, robust and effective regulation of medicines in the UK.
The ABPI is not keen on the UK going it alone when it comes to approving new medications.
‘Creating a standalone UK regulator, would require significant resource, time and expertise, and is likely to mean that patients in the UK have access to medicines after those in the US and Europe.’
One of the biggest pharmaceutical suppliers of HIV drugs is MSD, known as Merck in the US and Canada. Just this month, the FDA approved of two new drugs from the company to treat HIV in the US: Pifeltro and Delstrigo. How long it takes for those drugs to reach the EU – and UK – remains to be seen.
A spokesperson for the company voiced concerns around a potential lack of agreement between the UK and EU.
‘Europe – and the UK within this – has been one of the leading regions for drug discovery and development and has provided us with much of the scientific, regulatory and trade infrastructure that enables for medicines to reach patients.
‘The decisions around the EU’s and UK’s future partnership will have a critical bearing on the region’s future for drug discovery, development and manufacturing for years to come.’
More labelling, more packaging, more reviews
Any lack of agreement is also likely to prove extremely costly for pharmaceutical companies. GSK (Glaxo Smith Kline) has set aside a minimum of £70million to prepare for the initial impact of Brexit. That’s mainly to expand its drug review facilities across Europe to ensure new drugs receive approval quickly in both the EU and UK. New labelling and packaging may also need to be produced for the two territories.
On top of this cost, GSK’s most recent annual report suggests Brexit could cost it an additional £50million annually. The precise costings depends on what trade deals are stuck and what tariffs emerge.
Stockpiling drugs for a ‘no deal’ Brexit
The second concern is more focussed on disruptions to supply. The UK Government has already warned agencies to potentially stockpile drugs for an additional six weeks ahead of next March. This is in case a ‘no deal’ Brexit upsets trade in and out of the UK.
To keep costs low, the UK’s National Health Service (NHS) will usually opt to use generic versions of drugs when available. In fact, between 60-85% of all NHS prescriptions are for generic medicines.
However, some believe the pharma companies that produce generic drugs are less able to stockpile vast quantities as their profit margins tend to be narrower than the big pharma companies.
Steve Bates, chief executive of the UK Bioindustry Association, told Reuters in August that stockpiling six weeks’ supply across the industry is ‘a massive challenge.’
‘A “no deal” Brexit is where concerns about stockpiling come in,’ agrees Dayan of the Nuffield Trust.
‘This would risk causing a level of chaos and disorder much higher and more quickly than a “hard Brexit” with a deal, though some of the same concerns still apply.
‘The Government has said that they will support companies in stockpiling, and there is £3 billion in Treasury funding. Civil servants are aware of these issues and I hope they would be willing to stump up so that companies regardless of their profit margins are able to build up the necessary buffer.
‘Companies have already spent tens of millions of pounds making preparations’
A spokesperson for The Association of the British Pharmaceutical Industry said this to GSN.
‘Companies have already spent tens of millions of pounds making such preparations, including increasing stocks of specific medicines where possible. The Government has said it will look at how to support companies in making this preparations and we look forward to hearing more detail about what this support will entail.’
The Terrence Higgins Trust, the UK’s largest sexual health charity, wrote to the Government last month to ask if it had assurances from all the major pharmaceutical companies that they had taken steps to stockpile adequate amounts of HIV drugs. A response has yet to arrive.
‘Appalled by the Government’s nonchalant attitude towards a No Deal Brexit’
Matthew Hodson, Chief Executive of HIV information organization NAM, said: As someone living with diagnosed HIV my health depends on access to treatment. I am appalled by the Government’s nonchalant attitude towards a No Deal Brexit which threatens the medicinal supply chain.
‘Any form of Brexit is likely to delay access to new treatments.
‘During discussions with people who work in the pharmaceutical industry at the International AIDS 2018 conference [in July], I was told that a Brexit without a joined up medical regulatory agreement with the EU would push the UK towards the back of the queue in terms of licensing of new drugs. Smaller markets are simply less of a priority.
The British Medical Association wouldn’t comment on our specific questions relating to HIV drugs, but referred GSN to its June press briefing about its fears over a ‘no deal’ Brexit.
This bluntly stated: ‘The consequences of ‘no deal’ could have potentially catastrophic consequences for patients, the health workforce and services, and the nation’s health.’
It wants the MHRA to continue to participate in pan-European clinical trials, and for the EMA to have a formal agreement with the UK when it comes to the approval of new drugs. It also wants ongoing access to EU research programmes and research funding.
Besides concerns over the breakdown in cooperation between the UK and EU, it also raises other issues. These include the continuation of reciprocal healthcare arrangements for UK and EU citizens (something important for EU nationals with HIV living in the UK or UK citizens with HIV living in Europe).
‘My health is dependent on uninterrupted access to lifesaving HIV treatment’
Hodson, of NAM, says the UK has one of the best records in the world for treating people with HIV. He believes a ‘no deal’ Brexit put that at risk.
‘The UK currently is near the top of the world leagues for treating HIV. 96% of those who are diagnosed are on treatment, 97% of those are undetectable and so can’t pass the virus on to their sexual partners.
‘Our achievement is threatened if the treatment supply chain is threatened.
‘I know some people will always claim that any concerns are just Project Fear but we are clearly now looking at a No Deal Brexit as a possible outcome. I am not hearing sufficient assurance from the Government that they have more than short term plans in place to deal with this.
‘My health, just like the health of all other people living with HIV in the UK is dependent on uninterrupted access to lifesaving HIV treatment. Empty assurances that everything will be ok just aren’t enough right now.’
GSN has contacted the Department of Health for comment.