Jane Powell

4 1 JAN 2018
FromtheLordO’Shaughnessy
Parliamentary UnderSecretaryofStateforHealth (Lords)
Department
39 Victoria Street
of Health
London
Your Ref: 61026 SWIH OEU
020 72104850
PFD-1 105558
Ms Lisa Jeanette Hashmi 06 JAN2018
HM Area Coroner, Manchester North
HM Coroner’s Court
The Phoenix Centre
L/Cpl Stephen Shaw MC Way
Heywood OL1O 1LR
Thank you for your Report dated 30 October to the Department ofHealth about the
death ofMs Jane Allison Powell. I am responding as Minister with responsibility for
medicines regulation and I apologise for the slight delay in doing so.
I was very saddened to read ofthe circumstances surrounding Ms Powell’s death.
Please pass my condolences to her family and loved ones. I appreciate this must be a
very difficult time for them.
You ask for clarity on what action has been, or is being, taken to address the ease
with which individuals can obtain large amounts ofmedication (including
‘prescription only’) over the internet.
In preparation ofthis response, my officials have liaised with the Medicines and
Healthcare products Regulatory Agency (MHRA) and the General Pharmaceutical
Council (GPhC).
It might be helpful ifI first provide some background to the legal controls on the retail
sale, supply and advertisement ofmedicinal products in the UK.
Under medicines legislation, it is unlawful for medicinal products for human use to be
marketed, manufactured, imported from a third country, distributed and sold or supplied
in the UK except in accordance with the appropriate licences or exemptions. The UK has
three legal classes of authorised medicines:
• General sale list medicines are suitable for sale and normal use without supervision
or advice from a pharmacist or doctor;
• Pharmacy (P) medicines can only be obtained from a pharmacy and are sold or
supplied under the supervision of a pharmacist; and
• Prescription only medicines (POM) must be prescribed by an authorised healthcare
professional, for example a doctor, dentist, or independent prescriber.
Doctors may also supply medicines direct to patients for example, where they
—
personally administer a medicine such as a vaccine, or where they are able under specific
NHS arrangements to supply prescribed medicines to their patients as part ofan NHS
dispensing service
A UK registered pharmacy may have a presence on the internet; however, the
requirements oflegislation apply equally to both UK internet pharmacies and bricks-and-
mortar premises. A POM cannot be advertised directly to the public.
These legal controls apply equally to medicines for human use sold or supplied via the
internet or e-mail transactions. Some POMs are ‘Controlled drugs’ (such as
benzodiazepines) and their availability to patients can be subject to additional control
under the Misuse ofDrugs Act 1971, which is administered by the Home Office.
These restrictions do not apply to countries outside UKjurisdiction where medicines
may be classified and regulated differently. For example, in the US and other
countries some medicines that would be POMs in the UK are available without
prescription.
Medicines legislation does not prohibit the remote prescribing ofPOMs by a
qualified prescriber. However, prescriptions must meet the usual requirements set out
in medicines legislation.
Additionally, there are no formal restrictions on an individual importing medicines
into the UK provided they are strictly for use by that person or a member oftheir
immediate family.
The GPhC operates the Internet Pharmacy Logo, which helps members ofthe public
identify ifa website is being operated by a legitimate pharmacy in the UK.
In addition, under provisions in the European Falsified Medicines Directive (FMD),
Member States have been required to introduce national arrangements to register
suppliers ofmedicines at a distance. This has involved the establishment ofa
national website and the adoption ofa common EU logo. All websites supplying
medicines at a distance are required to display the EU logo and provide a hyperlink to
Department
of Health
the national website ofthe Member State in which the person offering to sell
medicines at a distance is established. These provisions took effect across the EU on
1 July 2015 and the MHRA is responsible for UK registrations.
The UK’s registration scheme for the online retail selling of a medicine is set out in
the Human Medicines Regulations 2012.
Other provisions in FMD relating to sales ofmedicines at a distance require all EU
Member States to make non-prescription medicines available online some Member
—
States allow POMs to be supplied electronically.
In terms ofguidance, the GPhC has produced “Guidance for registered pharmacies
providing pharmacy services at a distance including on the internet”. The General
Medical Council has issued guidance to doctors on good practice concerning
prescribing where they are not in face-to-face contact with the patient.
The MHRA has serious concerns about the availability ofmedicines being offered
via the internet. Medicines purchased from websites, particularly websites based
overseas, cannot be guaranteed to meet set standards ofquality, safety and efficacy
and the MHRA advises patients not to purchase medicines in this way.
The MHRA’s advice is issued with a view to protecting patient health; as you will be
aware, there have been cases in the UK where individuals have purchased medicines
online that have led to severe adverse reactions and death. Consequently, the MHRA
is working to ensure that there is proper guidance to support the safe purchase of
medicines over the internet, which it hopes will reconcile the increasing trend
towards electronic commerce, including the growth oflegitimate pharmacies trading
online, with the protection ofindividual patient safety and public health.
The MHRA is taking a range of action in this area. It routinely monitors medicines
being offered for sale on the internet and enforcement action can be taken
immediately against wrong-doing based in the UK. The MHRA investigates reports
ofillegal activity taking place on a website and, where appropriate, takes
enforcement action against suppliers who operate outside the legal requirements.
Considerable illegal activity takes place outside ofUKjurisdiction and websites
identified overseas are referred to the relevant country for appropriate action.
However, many set up their operations from countries where there is little, or no,
regulatory control. The MHRA therefore works closely with the EU and other
international regulatory authorities to ensure that, wherever possible, offending
websites are amended to reflect the law.
The MHRA, working with the internet service industry and other stakeholders, has
closed thousands ofwebsites, including websites based overseas, and brought into
compliance hundreds more.
In addition, the MHRA has investigated cases where POMs have been supplied to
members ofthe public from websites without a prescription and the involvement ofa
qualified healthcare professional. A number ofindividuals have been successfully
prosecuted by the MHRA for selling medicines illegally over the internet.
An example ofinternational collaboration to tackle the illegal online supply of
medicines is demonstrated by Operation Pangea.
This international initiative to target illegal internet trade in pharmaceutical products
was instigated by the MHRA in April 2006. It started as the UK Internet Day of
Action and has grown annually into an International Week ofAction. It is the largest
internet-based enforcement action ofits kind to date. It is coordinated by
INTERPOL and carried out with the assistance ofpolice, the World Customs
Organisation, and law enforcement agencies/drug regulatory agencies across the
world.
The latest Operation Pangea (Pangea X) was carried out recently and resulted in
more than 1.3 million units ofmedicines and devices seized with an estimated value
ofjust over £4 million.
In terms ofraising awareness among the public and healthcare professionals, in
August 2016, the MHRA launched the FakeMeds campaign, aimed at reducing online
purchases offalsified, unlicensed and counterfeit medicines and medical devices.
Channels used to promote the campaign include broadcast and print media, the
gov.uk website and social media, as well as relevant partnership networks. The
success ofthe campaign is being assessed through awareness of, and consumer
behaviour towards, online purchasing offalsified products ultimately leading to
reduced negative impact on public health.
With regard to the sad death ofMs Powell, I am advised that from the information
provided in your Report, it is not possible to determine ifMs Powell obtained
medicines online legitimately, or from a website operating illegally. The MHRA has
requested information from Greater Manchester Police on the evidence held in this
case relating to the purchase and supply ofmedicines from websites and will
investigate further once it has received those details.
Department
of Health
I hope this reply is helpful. Thank you for bringing the circumstances ofMs Powell’s
death to my attention.
JAMES O’SHA