Sunday, 12 November 2017

NHS Homeopathy #2 - More on GP Prescribing

A previous post discussed the NHS England Items which should not be routinely prescribed in primary care: A Consultation on guidance for CCGs. The intention was that this second post on NHS homeopathy would look at GP prescribing data in some detail in. However delays in obtaining the relevant data and certain events have conspired against this.

Some groups and individuals who support homeopathy have responded to the Government response to the petition started by Cristal Sumner CEO of the British Homeopathic Association (BHA). Also, the BHA have started a crowd funding campaign to apply for permission for a judicial review.

Responses to the Government Response
It would appear that the responses of the various UK homeopathy organisations are almost identical. This is not surprising as UK homeopathy tends to coordinate its PR somewhat better than it did in the past in the guise of a group known as 4Homeopathy. To quote from one post -
In essence, the government hasn’t replied to the evidence brought forward in favour of homeopathic and other complementary treatments. Their response blames the rising costs of all prescriptions, citing the need to cut medicines considered of low clinical value. Despite all evidence provided proving the benefits of homeopathy, the statement concludes that: 
“… We are not aware of any evidence that demonstrates the therapeutic effectiveness of homeopathic products.”
The problem here is that the evidence that homeopathy groups and individuals would have submitted would not prove homeopathy to have any benefit beyond placebo. Government, or more specifically the Department of Health, has replied. If UK homeopathy is expecting a point by point refutation of the "evidence" they supplied, it is deluded.

There were also bizarre reactions from the likes of Steve Scrutton but they are of no consequence beyond a possible comedic value.

Messages were also disseminated by 4Homeopathy et al to "keep up the pressure" on NHS England. To quote -
We all need to maintain the pressure during this critical time, to make decision-makers aware of the issues and inconsistencies which plague the consultation and its process. 
MPs need to be aware that NHS England is basing its decisions on a fundamentally flawed report which is not peer-reviewed evidence. Please write to your MP to make them aware of the issues and your concerns. To help create a letter we have provided some helpful information. Read through the points in our template letter, and please write in your own style to help ensure it is opened and read. 
Over 20,000 people have signed the parliamentary petition—Stop NHS England from removing herbal and homeopathic medicines—letting the government know that homeopathy should not have been part of the consultation. Keep sharing so we can have a stronger voice in representing patients and the public.
Although this does not mention it, there is an assumption that if the petition reaches 100,000 signatures, it will be debated in Parliament. The reality is that it may be debated. However, as discussed in the previous post, the petition is factually incorrect. A debate around a petition that states NHS England is attempting to ban GP prescribing herbal and homeopathic medicines when it doesn't have the powers to do so would not really be a debate.

And most recently, this -
The NHS is slowly dismantling our healthcare choices without proper and lawful consultation. 
Two days ago, the British Homeopathic Association (BHA) commenced its legal challenge, asking for a judicial review of the NHS England consultation, Items which should not be routinely prescribed in primary care. 
We have, from the outset, believed this consultation to be flawed, on a number of levels. Not only was the timing of the consultation suspect, homeopathy experts and practitioners were not consulted for the drafting of the proposal itself. But, most of all, it is obvious that this consultation never represented a genuine attempt to engage consultees – which is strongly suggestive of a pre-determined decision, one not to be overturned regardless of the outcome. 
We invite you to visit the British Homeopathic Association’s website to read the full reasoning behind the drive for this judicial review, but also to help support part of the legal costs they will face to get this judicial review.
Putting aside the matter of the judicial review, there are fundamental problems with the above. Nowhere is it made clear on what grounds the consultation is considered unlawful. Nor is any reason given why the timing is "suspect". Anyone with experience of being involved with NHS public consultations will understand that in most cases the decision is predetermined. Public consultation can be regarded as rubber stamping exercise.

Consultation Revisited
Before looking at the BHA's attempt to gain a judicial review, it is necessary to have some context. Returning to the consultation it states -
The commissioning guidance, upon which we are consulting, will be addressed to CCGs to support them to fulfil their duties around appropriate use of prescribing resources. It is proposed that the guidance will be statutory guidance issued under S14Z8 of the NHS Act. We expect CCGs to take the proposed guidance if and when issued into account in formulating local polices, and for prescribers to reflect local policies in their prescribing practice. The proposed guidance does not remove the clinical discretion of the prescriber in accordance with their professional duties.
Statutory guidance is a concept that is rarely explained very well. Essentially, some bodies are empowered by law to issue guidance that must legally be taken into due consideration by the persons/other bodies under the control of the first body. This does not mean that the guidance must be implemented but it necessary to demonstrate that due consideration has taken and the reasons why the guidance has not be implemented must be made clear. In most cases, statutory guidance is implemented. In the case of NHS England, it is not clear what sanctions are available in the case of non-compliance.

It is worth pointing out that the majority of CCGs are already largely compliant with any statutory guidance that may be enacted through local prescribing policies and formularies. It is also clear that there is an expectation on the part of NHS England that prescribers with abide by the guidance. Most GPs already do to some extent and will likely comply without issue.

It is important to note that NHS England says the guidance will not remove clinical discretion.

Rules for Public Consultation
An excellent presentation can be found on the Healthwatch website. It contains lots of references for the interested reader.

Government guidance can be found here. The principles are fairly self explanatory. 

GP Contract
As mentioned in the previous post, GPs are not directly employed by NHS England. They are contractors - generally CCGs contract with GP practices rather than individuals. The GP Contract is a contract in terms of law. The current GP Contract can be found here. Unfortunately, it is various parts and difficult to navigate. It is actually easier to look at the standard contract from 2016/17.

It is a long document and much of it is not relevant to this post. Section 14 deals with prescribing and dispensing. 
The Contractor must comply with any directions given by the Secretary of State for the purposes of section 88 of the 2006 Act as to the drugs, medicines or other substances which may or may not be ordered for patients in the provision of medical services under the Contract.
The Act in question is the National Health Service Act 2006. The relevant parts of section 88 state -
(1) A general medical services contract must contain provision requiring the contractor or contractors to comply with any directions given by the Secretary of State for the purposes of this section as to the drugs, medicines or other substances which may or may not be ordered for patients in the provision of medical services under the contract. 
(2) A direction under this section must, subject to subsection (3), be given by regulations.
The regulations mentioned start from National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004. In theory, the Regulations should be updated every year or so but were last done so in 2014. The Regulations represent the blacklisting/greylisting of medicines.

Non-compliance with the GP Contract can result in termination of the Contract or the withholding of monies. However, the process involved is cumbersome. It is not immediately clear if there are processes and systems in place that prevent the prescribing of medicines that are blacklisted. It would make sense if GP and community pharmacy IT systems prevent the prescribing/ordering of such medicines.

Local CCG prescribing policy and formulary enforcement
As stated in the previous post, CCGs do not seem to have any real sanctions against GPs who breach local prescribing policies. This article from the British Medical Association (BMA) spells this out in very clear terms even though it deals with excessive prescribing.

All the above makes clear the nature of the Consultation,the invalidity of petition raised by the BHA and the various "campaigning" communications.

Judicial Review
In essence, a judicial review is when a court is asked to rule whether the actions of a public body that result from powers granted to them by legislation are lawful. Judicial reviews often involve examining the decisions made by public bodies and whether the decisions are lawful. Often the process by which a decision is made is examined.

The Ministry of Justice has published the very useful Pre-Action Protocol for Judicial Review which unsurprisingly outlines the steps that should take place before an application is made for a judicial review. As it points out, the courts take the view that judicial review is a last resort and that alternative means of dispute resolution should be explored.

Before a judicial review takes place, it is necessary to apply to the High Court for leave to persue judicial review. The Court will not automatically grant leave. A number of factors may be taken into account -

  • Whether alternative dispute resolution has been exhausted
  • Whether the application has been made in time (typically a 3 month deadline)
  • Whether the applicant has sufficient legitimate interest (standing)
  • Whether the application concerns public law, rather than tort or contract law
If the Court feels strongly enough, leave may exceptionally be granted even if not all of these conditions are met.

Assuming that leave is granted for a judicial review, the Court will take into account various factors. 
  • Illegality (which can involve the Human Rights Act)
  • Irrationality (Unreasonableness)
  • Fairness
  • Procedural impropriety (statutory procedures have not been followed)
  • Legitimate expectation (basically where the complainant has been lead to believe that certain steps would take place and have not)
If the Court finds in favour of the complainant, there are a number of options available.
  • Quashing order (basically overturning a decision made by a public body)
  • Prohibiting order (prohibiting a public body from acting on a decision)
  • Mandatory order (ordering a public body to act when the decision was one of inaction)
  • Declaration (basically stating what the legal position of the parties are without making any order)
  • Injunction
  • Damages (rare)
  • Do nothing
The Public Law Project has produced a guide that is much easier to read that the Wikipedia article.

The costs of applying for leave for a judicial review are those of employing solictors and a barrister as well as a fee of £60 to the courts. These costs are non-recoverable. The legal fees will vary - it depends on how much work is involved.

If judicial review is granted, a court fee of £215 is payable. Again, the legal costs are difficult to ascertain but figures of £30,000 upwards have been mentioned. Something else that needs to be considered is that the losing party may be ordered to pay the costs of the opponent. In the case of a complainant losing to a public body, the costs could be considerable. Although things like Protective Costs Orders exist that can limit costs, these are only granted in genuine public interest cases.

Crowdfunding of a judicial review raises the question if costs are awarded, if and how they are returned to the funders.

 Aims of the BHA
One question that needs to be considered is whether the BHA has standing enough to warrant their application for a judicial review.Their about us says -
The principal objects of the charity are to promote and develop the study and practice of homeopathy and to advance education and research in the theory and practice of homeopathy provided that the useful results of such research shall be published.
 The entry at the Charity Commission states their activities are -
It is unclear whether a court would regard the BHA as having standing.

Previous Application for Judicial Review
The BHA did seek judicial review of the Lothian Health Board decision to decommission homeopathic clinic services. Or rather, they did so through a proxy. Andy Lewis wrote about this at some length so there is little point in repeating his analysis here.

The application for judicial review was dismissed. It is worth repeating a statement from the judge -
In any event, even if I had concluded that the Board had failed to comply with its PSED [public sector equality duty], I would have refused to reduce the decision under review. It is plain that the Board, as it was entitled to do, accepted the view that there was no scientific evidence for the efficacy of homeopathy and that funding for it was a waste of the limited funds at its disposal. In these circumstances the countervailing factor in this case was so powerful, indeed overwhelming, that no decision other than the one taken by the Board was conceivable. A different decision, namely, to continue spending money on a service whose efficacy was not established, would have been unreasonable.
It is difficult to say whether this sets a precedent.

The BHA Application for Judicial Review
The BHA state on their website -
The judicial review seeks, among other things, a declaration that NHS England has acted unlawfully in relation to its proposals, its failure to consult on them properly and to listen to patients! If successful, we can protect the right of patients to choose to be treated with homeopathy on the NHS and the right of the public to properly have input on the services that their National Health Service provides.
The crowdfunding page adds - 
We have commenced an application for judicial review on the basis that consultation was fundamentally flawed from the outset in that the proposal was not formulated with input from any homeopathy experts or practitioners; it was not a genuine attempt to engage consultees (a decision having been ostensibly predetermined) and did not provide consultees with adequate information on which to provide a considered and informed response.
Again, it is not clear on what grounds the BHA believe the consultation to be unlawful. 

There are questions regarding the existence and credibility of homeopathy "experts". It could be read as implying that BHA believe that NHS England is somehow incapable of evaluating evidence. It is not uncommon for homeopathy supporters to state that only those "qualified" in homeopathy are able to make judgements on its merits. This was dealt with in this post.

It is clear that scientific and medical consensus is that homeopathic medicines have an effect that is consistent with placebo and no greater. The National Institute for Health and Care Excellence (NICE) makes it clear that homeopathy is not recommded and that health professionals should make this clear to patients.

In terms of practitioners, although the data analysis has yet to be completed, it seems likely that the number of NHS England GPs who routinely prescribe homeopathic medicines is very low - a few tens. NHS England is under no obligation to consult with "practitioners" who i) are medically qualified and work in the private sector or ii) lay homeopaths or iii) homeopathy advocacy groups that do not directly represent either NHS practitioners or NHS patients. 

The number of patients prescribed homeopathic medicines by these tens of GPs is unknown. Whilst the number of prescriptions is known, it is unknown how many of these are repeat prescriptions. 

As the outcome of the consultation is not yet know the application can only be on the basis of process. It certainly the case that the consultation period was long enough. The consultation was widely publicised, especially by homeopathy supporters. Questions about whether enough engagement with patients etc was carried out are moot given the publicity.

The BHA's previous attempt at an application for judicial review focused on questions of health inequality. NHS England has addressed this here.

Without wishing to prejudge what the High Court determines, it seems very unlikely that leave for a judicial review will be granted. Even if it were, it is difficult to understand exactly what the BHA hope to achieve. It would be easy for NHS England simply to remove the sections of the Consultation that relate to homeopathic and herbal medicines. Not that it would change very much - CCGs would still be able to have local prescribing policies against such medicines.

The danger for the BHA and UK homeopathy in general is that any hearing could end up as placing the efficacy and validity of homeopathic medicines on trial. It could easily set a precedent that impacts on any further attempts by NHS England and/or CCGs to limit prescribing or comissioning of services.

The reputational damage that a hearing could cause for the BHA is impossible to estimate. If the mainstream media wereinterested, it could be considerable.

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