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Published 14 noviembre 2018
In the recent case of Bayer Plc and Novartis Pharmaceuticals UK Ltd v NHS Darlington CCG and Oths  EWHC 2465 (Admin), Whipple J rejected an application for judicial review that challenged the lawfulness of a policy of 12 Clinical Commissioning Groups (CCGs) giving the drug Avastin preferred status over the claimants' two licensed drugs, Eylea and Lucentis, for the treatment of a degenerative sight condition, neovascular (or "wet") age-related macular degeneration ("wet AMD"). All three drugs are anti-vascular endothelial growth factor (anti-VEGF) agents. The CCGs adopted the policy because of the significant difference in price between Avastin (around £28 per injection) and the other two medicines (around £816 and £551 per injection).
The Claimants argued that the policy would result in large-scale commercial supply of an unlicensed drug and that using an unlicensed/off-licence product when a licensed product existed undermined the law relating to the manufacture and supply of medicines for human use (in particular Directive 2001/83/EC on the Community code relating to medicinal products for human use (the “Directive”), which requires a product licence to be obtained before a product may be "placed on the market".
1. The relevant legal test was whether the policy was realistically capable of lawful implementation by NHS Trusts in a way which did not lead to, permit or encourage unlawful acts. The Court considered four potential ways in which Avastin might be supplied in practice and found that each at least might be lawful, such that the policy was not in itself unlawful. An individual decision under/pursuant to the policy could still be challenged as such.
2. The claimants significantly overstated the protection afforded to them by the Directive, which did not extend to protecting the commercial interests of pharmaceutical companies in a case such as this where there was substantial evidence of equivalent effectiveness and safety of Avastin and enormous jeopardy to the public purse. The Court recognised the role of national authorities (here, NICE and CCGs) in assessing efficacy, risk and overall clinical effectiveness of medicines (including issues of relative cost) and noted that this role is exclusively theirs for any medicine proposed for use outside its product licence. It would be "absurd" to reserve such assessments to the licensing authority, as that would give unbounded power to pharmaceutical companies to decide which medicines to make available for which purpose. Such a position would be seriously detrimental to the wider public interest in maintaining a cost-effective public health system.
3. There was an important distinction between the regulation/licensing of medicinal products and their use in medical practice. The effect of obtaining a product licence is that the product is recognised as safe and effective to be used in the way the licence specifies and may therefore be placed on the market; it does not create a legal obligation to prescribe the product.
4. As long as the provisions of the Directive are not breached, national authorities are free to choose which drugs they purchase, offer or reimburse, and may properly take into account the cost of medicines in making recommendations. Similarly, a prescriber can lawfully choose an unlicensed/off-label product because it is cheaper (if it is safe, effective, and appropriate for the patient), even where there is a licensed option available.
The judgment is important in suggesting that, at least in the context of Avastin for treatment of wet AMD, so long as an unlicensed product can be supplied lawfully under the Directive, national authorities and prescribers may choose to prefer it over licensed alternatives in the same way as an off-label product. Unsurprisingly, the claimant companies are seeking to appeal. The High Court refused permission to appeal on 26 October 2018, however the parties may still apply direct to the Court of Appeal and Bayer has indicated its intention to do so.
 In particular, where there was no compounding process (so the drug would be off-label but not unlicensed), or where no licence was required at all because Avastin was compounded "in house" by a hospital's own pharmacy (so was not 'placed on the market'), fell outside the scope of the Directive (as not being prepared "industrially") or within the exemption in Article 3.
 The GMC's guidance which states that a doctor should only prescribe an unlicensed medicine where there are “medical reasons” does not prohibit a clinician from prescribing an unlicensed drug simply because there are licensed alternatives and overall, the guidance positively required clinicians to take cost into account. A doctor might be found to have behaved inappropriately in prescribing an unlicensed drug and may face proceedings before his or her professional regulator, but professional misconduct isn’t the same as unlawfulness and a breach of professional guidance can’t be equated with a breach of the law.
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