QUEEN'S BENCH DIVISION
ADMINISTRATIVE COURT
Strand, London, WC2A 2LL |
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B e f o r e :
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THE QUEEN (on the application of GOOD LAW PROJECT LIMITED) |
Claimant |
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- and - |
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SECRETARY OF STATE FOR HEALTH AND SOCIAL CARE |
Defendant |
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(instructed by Deighton Pierce Glynn) for the Claimant
Sir James Eadie QC, Sarah Wilkinson and Saara Idelbi
(instructed by GLD) for the Defendant
Hearing date: 26 March 2019
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Crown Copyright ©
Mr Justice Supperstone :
"2 – General implementation of Treaties
(1) All such rights, powers, liabilities, obligations and restrictions from time to time created or arising by or under the Treaties, and all such remedies and procedures from time to time provided for by or under the Treaties, as in accordance with the Treaties are without further enactment to be given legal effect or used in the United Kingdom shall be recognised and available in law, and be enforced, allowed and followed accordingly; and the expression 'enforceable EU right' and similar expressions shall be read as referring to one to which this sub-section applies.
(2) Subject to Schedule 2 to this Act, at any time after its passing Her Majesty may by Order in Council, and any designated Minister or department may by order, rules, regulations or scheme, make provision—
(a) for the purpose of implementing any EU obligation of the United Kingdom, or enabling any such obligation to be implemented, or of enabling any rights enjoyed or to be enjoyed by the United Kingdom under or by virtue of the Treaties to be exercised; or
(b) for the purpose of dealing with matters arising out of or related to any such obligation or rights or the coming into force, or the operation from time to time, of sub-section (1) above;
and in the exercise of any statutory power or duty, including any power to give directions or to legislate by means of orders, rules, regulations or other subordinate instrument, the person entrusted with the power or duty may have regard to the objects of the EU and to any such obligation or rights aforesaid…"
"Implementation of the Falsified Medicines Directive and the Delegated Regulation
6.2 The EU has created a comprehensive code for the marketing, manufacturing, packaging, distribution, advertising and monitoring of human medicines. The framework for this is set out in Directive 2001/83/EC. This has been transposed into UK legislation through the 2012 Regulations.
Serious shortage protocol
6.5 Under Part 12 of the 2012 Regulations, medicines which are classed as prescription-only medicines (POM) can only be sold or supplied in accordance with an appropriate practitioner's prescription. An appropriate practitioner includes a doctor, dentist or other independent prescriber. This instrument makes provision for a 'serious shortage protocol' to be issued by Ministers where there is or may be a serious shortage of a prescription only medicine. This would enable pharmacists to sell or supply against the protocol rather than a prescription."
"The concept of 'due regard' requires the court to ensure that there has been a proper and conscientious focus on the statutory criteria, but if that is done, the court cannot interfere with the decision simply because it would have given greater weight to the equality implications of the decision than did the decision maker."
"11. We considered the implications for each of the three equality objectives in relation to the proposed framework. Our assessment is that there is no detrimental impact on particular protected groups. Whilst some of the groups are likely to use medicines more often, the protocol should have a positive impact on anyone taking medicines, including those with protected characteristics.
12. A serious shortage protocol would support pharmacists and GPs when there are serious shortages of medicines. The protocol would help manage available stocks and ensure patients have continued and quick access to medicines or any suitable alternatives if no stock is available. This benefits all patients, including those with protected characteristics. Even if on a particular occasion one patient might experience the detriment of, for example, receiving a smaller amount of a medicine than had been prescribed, that would be to the benefit of another patient who might not have received any of the medicine, had the rationing scheme not been in place. That is, the arrangements will be to the benefit of patients overall even if though underpinning this will be individual losses and gains."