Newsflash: Court confirms commission of PrEP is within NHS England’s powers

Summary

The Court held that NHS England does have the power to commission Pre-Exposure Prophylaxis (“PrEP”).

Background

The Court of Appeal considered whether it was within NHS England’s power to fund PrEP or whether such a responsibility was more appropriately dealt with by the local authority. At first instance, the judge, Mr Justice Green, held that such a decision was within NHS England’s power for the following reasons:

  1. NHS England has a duty in relation to public health functions (which would it was held include PrEP)  by virtue of s1H(2) of the National Health Service Act 2006 (“NHSA 2006”);
  2. The National Health Service Commissioning Board and Clinical Commissioning Group (Responsibilities and Standing Rules) Regulations 2012 (“the 2012 Regulations”) conferred power on NHS England to commission preventative HIV treatment;
    and if the above conclusions were wrong,
  3. PrEP was not a preventative treatment but was a “treatment” like post-exposure prophylaxis (“PEP”) which NHS England were currently funding; and
  4. NHS England is able to fund PrEP under its general powers of section 2 of NHSA 2006.
    NHS England appealed this decision.

Court of Appeal Judgment

Lord Justice Longmore, Lord Justice Underhill and Lady Justice King agreed with the first instance Judge that NHS England has the power to commission PrEP but for differing reasons.

All three judges rejected the rationale for Mr Justice Green’s first conclusion and instead, in determining NHS England’s powers under NHSA 2006, focused on the 2012 Regulations and how these set out the scope of local authorities’ responsibilities.

The 2012 Regulations state that it was NHS England’s  responsibility to provide “Adult specialist services for patients infected with HIV” (Schedule 4, paragraph 17). Lord Justice Longmore held that the definition of “services” in this case included the “prevention” of HIV and therefore NHS England has the power to fund PrEP. He also considered that the burden on NHS England to commission treatment for HIV would be reduced if it also has the power to commission preventative treatment, like PrEP. This is because it would reduce the overall burden on the NHS of providing treatment for those who become infected with HIV and require on-going treatment for the remainder of their lives.

Lord Justice Underhill felt that, on a literal reading, PrEP would not be covered by Schedule 4, paragraph 17 of the 2012 Regulations.eHe determined that NHS England has the power to fund PrEP on the basis that in drafting the 2012 Regulations,  the Secretary of State for Health  could not have intended to fragment responsibility between the local authority and NHS England for two such similar treatments (PEP and PrEP). In support of this conclusion, he stated that individuals eligible to take PrEP should be classed as having been “infected with HIV”. His rationale for this conclusion was the drug worked by inhibiting the replication of the virus in those infected. Therefore “if one focuses on the point in time when the treatment has its intended benefits rather than the moment of the prescription PrEP can in substance be said to be a treatment for “persons infected with HIV”.”

Lady Justice King agreed with the conclusion of Lord Justice Longmore but felt it needed the support of Lord Underhill’s rationale in concluding that  NHS England had the power to fund PrEP. By relying upon both of these arguments, she felt it was clear that NHS England had the power to fund. She added  that NHS England also had the power under section 2 and section 7A of NHSA 2006 although these were more cumbersome options.

Commentary

All four judges involved in these cases have reached the same conclusion on funding responsibility despite the differences in analysis.

Lord Justice Underhill acknowledged that NHS England’s submissions as to the scope of Paragraph 17 of Schedule 4 “not only corresponds to the literal language of the 2012 Regulations but would correspond to a coherent scheme”, but nonetheless concluded that NHS England has the power to commission PrEP.

It seems that, despite on a literal interpretation of the legislation potentially indicating the contrary, the Court was determined to find that NHS England had the power to fund PrEP (although both LJ Underhill and LJ King commented that whether it chose to do so was another matter). This is a good example of the Court adopting a pragmatic, logical solution, in terms of which organisation is most appropriate to commission PrEP even though, on a strict interpretation of the legislation, this scenario had not been envisaged. The Court commented that the apportionment of responsibility and the resulting “bureaucratic squabbles…will be the inevitable consequence of the Lansley reforms” and in doubting whether such squabbles were best resolved in the Courts suggested that it would be more appropriate to “have an internal mechanism for sorting out such disputes”.

The facts of this case are very specific and to a certain extent the conclusions reached turn on the chemistry of the drug itself.  It does not amount to a judicial directive that  commissioners, NHS England or CCGs,  fund more elements of  public health services. In the context of limited resources, further disputes may arise over the extent of funding responsibility and relevant legislation will need to be scrutinised, bearing in mind funding decisions already made for certain drugs or programmes. In the first instance, public bodies should   make every effort to resolve the matter locally  in view of the suggestion by the Court that “an internal mechanism” would be preferred to resorting to legal proceedings. They may face judicial criticism and associated publicity if they fail to do so.