On 18 January, a new statutory instrument, the Human Medicines (Amendment) Regulations 2019 (the Amending Regulations), which amend the Human Medicines Regulations 2012,  was laid before Parliament.  These regulations will come into force on 9 February 2019.

The principal purpose of the amendments is to transpose into UK legislation the remaining provisions of Directive 2011/62/EU (the Falsified Medicines Directive), which require two new safety features to appear on the packaging of certain medicinal products, and the associated Commission Delegated Regulation 2016/161/EU (the Delegated Regulation), which sets out the details of these features. However, the Amending Regulations have also introduced an important new provision allowing for “serious shortage protocols” (SSPs) to be put in place for prescription-only medicines (POMs) in certain circumstances, and have extended the types of product containing naloxone (indicated for the treatment of opioid overdose) that drug treatment services may supply in an emergency.

Implementation of the Falsified Medicines Directive

The Falsified Medicines Directive introduces harmonised measures to prevent the entry of falsified, or counterfeit, medicines into the legal supply chain. Most of its provisions were transposed into UK legislation in 2013.

The Amending Regulations implement the remaining parts of the Falsified Medicines Directive, which require two new safety features, that enables the verification and identification of the product in question, to appear on the packaging of almost all POMs for sale in the European Economic Area: (i) a unique identifier contained in a 2D bar code; and (ii) an anti-tampering device. Wholesalers (including manufacturers conducting wholesale distribution activities) are required to scan the 2D barcode at various points in the supply chain to verify the authenticity of the medicinal product.

From 9 February 2019, medicines manufacturers will be required to place the safety measures on the packaging of certain medicines and upload information into a European data repository, as we discussed in a previous post.

The general rule is that persons authorised to supply medicinal products to the public shall verify the safety features at the time of such supply, and decommission the unique identifier. The Amending Regulations, however, adopt the optional provisions at Article 23 of the Delegated Regulation, which require wholesalers to verify and decommission the unique identifier at the time of supply to certain categories of persons (who are therefore relieved of the verification and decommissioning obligation) including: persons who are authorised or entitled to supply medicinal products to the public but do not operate within a healthcare institution or pharmacy; dentists; registered optometrists and registered dispensing opticians; registered paramedics; members of the armed forces; police forces, government institutions maintaining stocks of medicinal products for the purpose of civil protection or disaster control; universities or other higher education or research institutions; prison services; persons carrying on the business of a school; care homes; and hospices.

The Amending Regulations create various offences relating to breaches of the new requirements in the UK, including the detailed provisions of the Delegated Regulation by marketing authorisation holders, parallel distributors, persons authorised to supply medicinal products to the public, and legal entities managing repositories where information on the safety features is contained, and establishes powers of inspection, sampling and seizure.

Serious Shortage Protocol

The current provisions of the Human Medicines Regulations 2012 require the sale or supply of POMs only in accordance with a prescription given by an appropriate practitioner (i.e. a doctor, dentist, supplementary prescriber or a nurse or pharmacist independent prescriber). The Amending Regulations make provision, via new regulation 226A, for a serious shortage protocol (SSP) to be issued by the Ministers where there is or may be a serious shortage of a POM. This written protocol would enable pharmacists to sell or supply against the protocol rather than a prescription.  The new provisions have been prompted principally, although not exclusively, by the risk of medicines shortages in the event of a “no deal” Brexit.

Currently, if a pharmacist is unable to dispense the POM as prescribed, he or she may not dispense an alternative unless the prescription is or will be revised by the prescriber. The purpose of the amendment is that, in the event of a serious shortage of a POM that affects or may affect the whole or any part of the UK, an SSP may be issued by Ministers which allows pharmacists to dispense a different quantity, pharmaceutical form or strength of the POM to that prescribed, or a different POM (a generic equivalent, a similar biological medicinal product or a therapeutic equivalent) as specified in the SSP without reverting to the prescriber for revision of the prescription. The SSP should specify the period for which and the parts of the UK in which the protocol is to have effect.

The Department of Health stated, in its response to consultation on the proposal to introduce SSPs, that these would be used only in exceptional circumstances if they would assist in managing the supply situation, and if clinicians consider them appropriate, after discussion with the manufacturer and/or marketing authorisation holder. Protocols for therapeutic or generic equivalents will not be suitable for all medicines and patients. For example, the Department of Health states that those types of SSP would not be suitable for treatments for epilepsy or treatments requiring biological products where the medicines that are prescribed need to be prescribed by brand for clinical reasons. In these cases, patients would always be referred to the prescriber for any decision about their treatment, before a therapeutic or generic alternative is supplied.

Ministers are required to review the operation of the new regulation 226A, in particular whether it has resulted in any adverse consequences for the market in POMs or for patient safety, and to publish a report as soon as is reasonably practical after the end of one year, beginning on the day on which the first SSP is issued.

Availability of Naloxone

Finally, the new Amending Regulations provide for drug treatment services to obtain and supply all preparations of naloxone, not limited to the injectable preparation that is already listed in the current text of the Human Medicines Regulations 2012. Public Health England will work with the Department of Health and Social Care and the MHRA to publish advice supplementary to existing guidance.