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Umesh Modi is a chartered accountant, and Pamini Jatheeskumar is a chartered certified accountant at Silver Levene...
  Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead...
Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead pharmacist, Health and Wellbeing Directorate, Public Health England
More inWhite Papers  

a magnifying glass imageFebruary 27 2018

The medicines regulator has published its findings on complaints involving two issues involving pharmacies.

In a case involving Nelsons Homeopathic Pharmacy in London, the MHRA upheld the complaint which involved the promotion of registered homoeopathic and unlicensed medicines. The complaint had been made by the Nightingale Collaboration which states it “challenges questionable claims made by healthcare practitioners”.

The MHRA upheld the complaint, and stated: “Nelsons Homeopathic Pharmacy confirmed that medicines without a marketing authorisation or homeopathic registration were no longer being advertised and that they had reviewed their promotional material to ensure that all claims for licensed or registered medicines were consistent with their Summary of Product Characteristics. Nelsons also confirmed that, in line with our guidance on section 10 of the Medicines Act 1968, unlicensed medicines were no longer available for self-selection.”

In addition, the Nightingale Collaboration had “provided further evidence demonstrating that material providing indications for unlicensed medicines and medicines registered without indications was still present in the pharmacy. Furthermore, unlicensed medicines remained available for self-selection,” said the MHRA.

The MHRA acknowledged that Nelsons had subsequently “provided further assurance that they had addressed our concerns,” something that was confirmed in a later visit by the MHRA to the premises.

Concerns about the funding and sponsorship of pharmacy wholesaler overseas conferences had been raised in 2017. Specific events covered by the investigation were:

  • Sigma Conference in Rio de Janeiro in February 2017;
  • AAH Pharmaceuticals Conference in Kenya in March 2017;
  • Numark International Conference 2017 in Cape Town, South Africa in March 2017;
  • Avicenna Conference in Vietnam in October 2017.

Of concern for the MHRA was that the wholesalers organising the conferences were providing some financial support along with other sponsors “including several companies involved in the manufacture, supply or sale of medicines.”

In particular, the MHRA “was concerned that the financial support extended to parts of the social programme and was not strictly limited to healthcare professionals and to that required to support the scientific or business meetings as required by regulation 300(2) of the Human Medicines Regulations 2012.”

The companies challenged the MHRA view that the sponsorship of a conference for persons qualified to prescribe or supply (PQPS) medicines by a pharmaceutical company constituted a promotional activity under the terms of regulation 7 of the Human Medicines Regulations 2012. Instead, they maintained that the conferences were not held for the purpose of the promotion of medicines.

“However, in order to reach agreement that the review could be concluded with no further action, they agreed to make changes to future events to ensure that hospitality is strictly limited to that required to support the scientific programme and is provided only to healthcare professionals,” said the MHRA.

Links:
MHRA statement: ‘Nelsons Homeopathic Pharmacy’    
The Nightingale Collaboration  
MHRA statement ‘Overseas Conferences Organised by UK Wholesalers in 2017’
MHRA ‘Advertising investigations: December 2017’      

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