We have seen a number of recent developments in the regulation of healthcare professionals which signify a significant shift in direction from the last few years. In this article we summarise some of those changes and make some predictions for future trends.
“Bonfire of the quangos” and the new kid on the block
In October 2010, in the well publicised “bonfire of the quangos”, the Government announced its intention to cull 192 government agencies, merge 118 bodies and substantially reform another 171 in an effort to improve accountability and cut costs. Healthcare is an area which has provoked intense debate, with decisions to abolish the Human Fertilisation and Embryology Authority, the Human Tissue Authority and the Council for Healthcare Regulatory Excellence. These cuts have been criticised by a select committee, but the Government seems committed to seeing through the reforms. It remains to be seen what the new regulatory framework will look like in practice, but it is clear that the Care Quality Commission has not only survived the cull, but will strengthen its powers as a result of absorbing various bodies. Whilst not easy against a backdrop of constant change, the best advice to professionals remains to build and maintain a good working relationship with the regulator(s) in place.
Whilst the “bonfire” was still being built, a new regulatory body was preparing to become operational; the General Pharmaceutical Council (GPhC), which commenced its operations at the end of September 2010. The GPhC regulates pharmacists, pharmacy technicians and those employing/owning pharmacies and replaces the Royal Pharmaceutical Society of Great Britain. The aim of the GPhC is to regulate the pharmacy profession to the same level as other healthcare professions and introduce new standards for regulation.
Fitness to Practise – General Medical Council
There have been substantial case law developments and publication of guidance over the last year or so. Of particular relevance is new guidance on warnings. A major change is that a warning will be kept on record and disclosed to employers on request indefinitely. Previously the warning would expire after five years. Now it will only be removed from the published list and to general enquirers after five years.
There is also new guidance on undertakings and voluntary erasure applications. This new guidance, coupled with the case law and identified trends, means, in our opinion, there is greater scope for avoiding the more punitive sanctions available to the GMC, which is good news for medical professionals. This is especially so for those who have made a one-off mistake. The statistics show that between 2008 and 2009 there was a 57% increase in the number of cases where the GMC found there was no impairment of fitness to practise. It will be interesting to see whether the 2010 figures support this trend. As always, each case will be decided on its particular facts, but it may be that GMC panels are starting to adopt a more flexible, less stringent, approach.
Inequality on restoration between healthcare regulators
This is becoming a very live issue. Many regulators introduced a five year minimum removal / erasure period from around 2003 onwards. This has led to an increase in restoration applications as the minimum term is expiring, and this is predicted to continue. Case law has highlighted the discrepancies between the tests imposed by different healthcare regulators and that sometimes the relationship between registration and restoration is not as clear as might be anticipated. For example, the GMC requires a fee of £6k and demonstration of competence prior to restoration to the medical register. This raises the question as to what is meant by “competence” and the problem of how a doctor can demonstrate this if he/she has been unable to practise for a lengthy period. We anticipate that we will see more developments in this area over the next year.
Care Quality Commission – from strength to strength
As all those working in healthcare will know, the Care Quality Commission (CQC) has been operational since 1 April 2009. Its powers regarding enforcement are stronger than those of its predecessor, the Healthcare Commission, and breach of certain regulations can result in criminal sanctions. The CQC has been quick to flex its muscles with reports into Mid Staffordshire NHS Trust and Take Care Now, which have attracted much publicity. The CQC’s website contains a running list of healthcare providers that have felt the CQC’s wrath. Its role is expected to increase now that independent healthcare providers and social care organisations fall within the CQC’s remit.
One of the trends we have seen is failure to comply with the regulations which require the reporting of particular injuries, certain deaths, allegations of abuse and any incidents involving the police. If in doubt, healthcare providers should err on the side of caution, if necessary after taking legal advice. In 2011, all healthcare organisations will need to be careful to avoid the reputational consequences, as well as the legal consequences, of falling foul of the CQC.