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As the January Dental Update Comment went to press,1 the European Union swiftly ratified the banning of dental amalgam from use and export, with an implementation date of January 2025, except when the use of dental amalgam is deemed strictly necessary by the dental practitioner to address specific medical needs of the patient (a previously used, rather ambiguous term). This led to an outcry from across the profession in the UK, with the British Dental Association highlighting the impact on an already struggling NHS dental service. Indeed, the impact of the amalgam ban in the EU may disproportionately affect the patients who present with late caries, as is frequently seen across the UK, accepting that many patients never have the opportunity to get as far as a dentist.2 The British Dental Association highlighted that since the Minimata Agreement in 2013, we have known this was coming, but not quite now, stating:3
‘We have long supported a phase-down in dental amalgam. But this rapid phase-out is neither feasible nor justifiable.’
‘We have stressed there are currently no alternative restorative materials that compete with amalgam on speed of placement or longevity.’
‘When alternative materials can't compete, this will add new costs and new uncertainties to practices already on the brink.’
‘Without decisive action this could be the straw that breaks the back of NHS dentistry.
The European Union clearly differ on whether the new ban is justifiable or not, citing environmental concerns overriding the use of dental amalgam. Of course, nobody can have failed to notice we are no longer in the European Union, but import costs of amalgam, its availability and the Windsor protocol mean that if Europe sneezes, the UK catches a cold. In this case, NHS patients in most need will suffer, because it is in that group where amalgam use is likely to be highest, and the increased cost will impact most, one way or another.
There are other reasons (perhaps the main reason), for the withdrawal of support for amalgam much earlier than the date initially planned, 2030. The European Network for Environmental Medicine published a document a year ago,4 outlining reasons why the availability of amalgam will become increasingly limited, citing the new Medical Devices Regulation (MDR 2017/745) that came into force in May 2021, bringing much increased legal safety requirements for dental amalgam capsules, and, as a result, why six European manufacturers/distributors (including two in the UK) have left the amalgam business, with two major US players also leaving the market and others facing the end of their certification. As a result, therefore, the ‘writing was on the wall’ for amalgam in the EU, and, as stated above, there will be a knock-on effect in the UK. Anecdotally, on talking with dentists from around Europe, resin composite is much more widely used there for posterior teeth than in the UK, where results of the most recent survey of 500 UK dentists (response rate 78%) in 2016, indicated that 66% of respondents used resin composite for Class II restorations in premolars, with amalgam being used 7% more for Class II restorations in molars than composite (55% vs 48%).5 Unfortunately, this research did not investigate whether there were differences in material use in NHS and private practice. Nevertheless, it is apparent from the above data that only half of UK dentists would have to change their materials' prescribing habits if it became impossible to obtain amalgam, or if it became substantially more expensive. In that regard, there is a possibility of obtaining amalgam from other countries, such as the US, India and Mexico. Readers might suggest China (after all, we get so many manufactured goods from there!), but China has restricted the construction and renovation of dental amalgam material production devices since 2019.4
It may be of interest to note that, outwith the EU, increased restrictions on the use of amalgam were introduced by the US Food and Drug Administration (FDA) on the use of dental amalgam, recommending that mercury-containing fillings should no longer be used for patients with neurological diseases, such as multiple sclerosis, Alzheimer's and Parkinson's, as well as for patients with impaired kidney function and women who wish to have children.
One is then left pondering whether the profession has been asleep at the wheel with regards to developing cost-effective amalgam replacements, and the EU directive is indeed a rude awakening. We have known since the Minamata Agreement (2013) that the post-amalgam era was coming. The question then becomes whether a cost-effective replacement can be found and, if not, is it a matter of costing in time and materials if we are to offer patients a satisfactory restoration when compared to amalgam. We suggested some in the previous editorial. No doubt, as many have trained in the use of amalgam at dental school and beyond, we can be time and cost effective in producing predictable amalgam restorations, but what now, when the amalgam option will become more costly and less available? Perhaps restorations that take longer to place (such as resin composite) will end up being not being more expensive after all?
As we go to press on this fast-moving story, a press release on 30th January provided a ‘get out of jail’ or ‘keep mercury in’ clause for member states that might feel that their subjects are disadvantaged by the ban, as follows:6
‘The Council of the EU maintained the Commission's proposed date for the total phase-out in the EU, 1 January 2025. However, it introduced atwo-year derogationfor those member states where low-income individuals would otherwise be socio-economically disproportionally affected by a phase-out date of1 January 2025. Those member states will have to justify their use of the derogation and notify the Commission of the measures they intend to implement to achieve the phase-out by 1 January 2027.
In addition, the press release stated:
‘While the Council maintained the prohibition to export dental amalgam from 1 January 2025 as proposed by the Commission, it agreed to ban the manufacturing and import in the EU from 1 January 2027.
It may be considered that this represents a softening of the original ruling, which seemed to be proceeding unusually quickly.
The government seem reluctant to properly fund NHS dentistry and, as clinicians are aware, dentistry on the cheap is a bit better than no dentistry, but to do it well takes time and access to the correct materials. Martin Kelleher and Kevin Lewis allude to this in their excellent discussion of ‘satisficing’ in this issue. Materials have, of course, improved dramatically over time, with bonding becoming simpler and more effective, and composites developing better wear resistance, strength and aesthetics, but, as ever, to do dentistry to a good standard takes time, and to a gold standard even longer. Even with amalgam, if you wish to do these restorations well, it will be time consuming. Any type of dentistry done in a rush is always a compromise. Perhaps the lack of availability of amalgam, or the increased cost of importing it, could be considered the death knell of NHS dentistry. On the other hand, perhaps this is the wake-up call that was needed to bring the UK dental profession's use of materials into the modern world, and to jolt the funders of NHS dentistry into a realization that without adequate funding, and with the current contract, all treatment will be a compromise, and the question is how much of a compromise patients, the profession, regulators, and the funders are willing to accept.