While a UK government-led working group gets cracking on UK regulation, we ponder the bigger picture
After almost three years of inaction, a working group convened by the UK government has finally begun discussions on how best to regulate the country’s herbal practitioners and products. And while the working group may turn out to be a talking shop, we’re delighted to bring news of what may turn out to be the best hope of reforming appalling EU legislation on herbal products: the ANH-Intl legal challenge.
A neglected promise
The issue of regulation of the UK herbal profession has remained firmly in the doldrums ever since Andrew Lansley MP’s promise to enact a statutory register for practitioners. Thirty-three months have passed with no developments, despite the best efforts of a concerned UK herbal sector bemused at the lack of government action.
Working group gets working
Last Thursday saw the first meeting of the government’s latest working group set up to discuss the matter, co-chaired by Professor David Walker, UK Deputy Chief Medical Officer, and David Tredinnick MP. Below is a brief summary of the proceedings and outcomes from the discussions:
According to the government, the legal situation has undergone a fundamental shift since its February 2011 announcement on statutory regulation (SR). By setting up a statutory register of UK herbal practitioners, it had intended to use Article 5.1 of European Union (EU) Directive 2001/83/EC to confer “authorised health-care professional” status on them. This would have restored their access to unlicensed, manufactured herbal medicines – an opportunity that was denied to UK practitioners when the exemption for use of these products was revoked on 1st May 2011 coinciding with the full implementation of the Traditional Herbal Medicinal Products Directive (THMPD; Directive 2004/24/EC). The impact of this has however been delayed given the MHRA’s decision to allow ‘sell-through’ of unregistered herbal medicines in the supply chain up until the end of April 2014. These manufactured products are particularly crucial to practitioners of non-European traditional systems of medicine, most notably traditional Chinese medicine and Ayurveda, whose herbal practise in the UK revolves around complex, manufactured polyherbal formulae almost entirely excluded from the THMPD
The government insists offering British herbalists an exemption under the exemption in EU medicines law is no longer possible, courtesy of a European Court of Justice (ECJ) judgment. The precedent case was brought by the European Commission (EC) against Poland after they were accused of abusing EU medicines law by granting national product licenses for drugs licensed elsewhere in the EU that were not regarded as equivalent
The judgment makes it clear that Article 5.1 is to be strictly interpreted and applied only in exceptional circumstances. Unfortunately, these circumstances are not likely to include helping out herbalists: Article 5.1 was written to allow medical doctors, and pharmacists, to prescribe unlicensed medicines (‘specials’) to named patients in cases of need
While statutorily regulated herbalists may be able to use Article 5.1 to make up ‘specials’, the same Article cannot be used to put unlicensed, manufactured herbal products back into the hands of UK herbalists
However, the manufactured products issue is entirely separate from that of practitioner regulation
Top of the agenda for future working group meetings will be whether legislation for a system of herbal practitioner regulation – on a statutory or voluntarily self-regulated basis – can proceed without delay
The working group will also address the regulation of herbal products, a prime agenda point being to explore ways of ensuring legal access to the widest possible range of herbal products for practitioners of all traditions.
A possible solution – and a likely problem
ANH-Intl, along with its sister organisation, ANH Consultancy, has been working on these issues for many years now. Along with our partners at the European Benefyt Foundation, we have developed a comprehensive strategy that we believe would solve all of these problems – and more – throughout the EU. Obviously, the success of this strategy relies on the EC and Members of the European Parliament (MEPs) buying into it. The EC’s own experience report of 2008 recognised the inadequacy of the current system for regulating holistic systems of medicine, including TCM and Ayurveda. The ANH-Intl/Benefyt model for an EU-wide regulatory regime to allow practitioners the ability to prescribe herbs and herbal products that are not necessarily available to the lay public was developed specifically to fill this gap. Getting the UK and other governments to back relevant aspects of the strategy would add some much-needed impetus at a time when change is urgently required.
Working group – or talking shop?
Unfortunately, with the working group’s final report not due until March 2015, a mere 2 months before the UK general election, something will have to give in order for herbal practitioner regulation to avoid another indefinite spell in the long grass. Whether that is the proposed timetable or SR, the preferred solution of much of the UK herbal sector, remains to be seen.
Legal challenge moves a step closer
One of the three key planks of the ANH-Intl/Benefyt strategy is our proposed judicial review of herb-related EU legislation. And, in keeping with the theme of welcome developments in long-promised initiatives, we are increasingly hopeful that we may soon be in a position to file the initial brief for the case. In other words, things — external, uncontrollable factors aside — are hopefully about to get very interesting indeed! On this, and all other herb-related matters, we’ll keep you posted.
In many ways, the timing couldn’t be better. The reason for the problems described above – the loss to UK herbal practitioners of many or most of their key products – is down to broken legislation coupled with an over-zealous medicines regulator. The Medicines and Healthcare products Regulatory Agency (MHRA) is tasked with managing the tricky borderline area between foods and medicines. In the THMPD era, the MHRA is increasingly classifying herbal products as unlicensed herbal medicines, rather than perfectly legal botanical food supplements – meaning that unless their manufacturer can afford the time and expense of the notorious Traditional Herbal Registration (THR) approval process, they become illegal. With the approaching end of the ‘sell-through’ period for existing stocks of unlicensed products, we can expect things to become exponentially worse if the MHRA chooses to enforce the law strictly from 30th April this year.
The public, herbal practitioners and those passionate about keeping alive humanity’s association with plant-based medicine will need to step up to the plate. That’s what’s always been required in the past when governments have attempted to limit public freedoms and prescribing rights. Looking to the future, it’s the one thing that will continue to be required if freedoms are to be upheld.