Passing off medicines and trade mark infringement - the colour purple
Posted: Thursday, October 17th, 2019
In Glaxo Wellcome UK Ltd v Sandoz Ltd  EWHC 2545 (Ch), Mr Justice Arnold had to rule on a claim by Glaxo that Sandoz were passing off a generic Accuhaler as Glaxo’s Seretide. Seretide has purple colouring and the claim was largely based on the adoption by Sandoz of a similar colour scheme. Glaxo alleged that patients were likely think that the Sandoz inhaler was from the manufacturers of Seretide and that the use of the colour purple misrepresented to healthcare professionals and patients that the generic inhaler was equivalent to the Accuhaler even though its mechanism, strength and licenced use were different.
Mr Justice Arnold dismissed Glaxo’s claims. He found there was no evidence that patients would assume that any purple inhaler came from the manufacturers of Seretide and there was no evidence that patients had been confused. There was no evidence of confusion on the part of healthcare professionals.
When describing the regulatory regime relating to the supply of medicinal products, the judge noted (paragraph 43) the requirement in regulation 214 of the Human Medicines Regulations 2012 to supply a Prescription Only Medicine in accordance with a prescription, and observed that if a pharmacist supplied a generic medicine when a branded product had been prescribed, this would not only be an offence, but also a trade mark infringement and/or the tort of passing off.
Veterinary medicines after Brexit
Posted: Thursday, October 17th, 2019
The Government has announced that all veterinary medicines authorised for use in the UK will continue to be authorised after Brexit and can remain on the market for sale and supply in their existing packaging https://www.gov.uk/government/news/veterinary-medicines-will-continue-to-be-available-after-brexit-joint-statement-from-vmd-and-noah?utm_source=a036be0e-fdc4-47e9-9e43-abebfeaf6481&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
Government Brexit Guidance on medicines and medical devices
Posted: Thursday, October 10th, 2019
The Government has published a raft of Brexit guidance relating to medicines. The guidance specifically relates to a no-deal Brexit. There is too much to summarise here. A list of the guidance and the links is as follows:
- Exporting active substances for medicines https://www.gov.uk/government/publications/exporting-active-substance-manufacturer-in-the-uk-if-we-leave-the-eu-without-a-deal?utm_source=9ed76ae9-5dd4-41d9-8f28-9d9aade1ba0e&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Importation of investigational medicinal products https://www.gov.uk/government/publications/guidance-on-importation-of-investigational-medicinal-products-from-approval-countries?utm_source=38b3d355-6cc5-44a7-b399-c30c0b520d51&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- How orphan medicinal products will be managed https://www.gov.uk/government/publications/guidance-on-importation-of-investigational-medicinal-products-from-approval-countries?utm_source=38b3d355-6cc5-44a7-b399-c30c0b520d51&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Provision for traditional herbal medicinal products and homeopthic medicinal products https://www.gov.uk/guidance/guidance-on-new-provisions-for-traditional-herbal-medicinal-products-and-homoeopathic-medicinal-products-in-a-no-deal-scenario?utm_source=5e0f7db6-852f-47b1-8971-136b554702c1&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Importing medicines from the EEA https://www.gov.uk/government/publications/importing-medicines-from-an-eea-state-which-is-on-an-approved-country-for-import-list?utm_source=e54665db-d807-4057-ad89-1719ac089b38&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Applying for a certificate of pharmaceutical product https://www.gov.uk/guidance/applying-for-a-certificate-of-pharmaceutical-product-in-a-no-deal-scenario?utm_source=2b068dd1-5fb7-47c4-aa3b-7b1d58f14b92&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Guidance on air freight of medicines https://www.gov.uk/government/publications/guidance-on-distribution-and-importation-of-medicines-and-active-substance-from-approved-countries?utm_source=e2cdee10-0fed-4e60-9dc1-47b1b908f674&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Converting Centrally Authorised Products to UK marketing authorisations https://www.gov.uk/government/publications/guidance-on-distribution-and-importation-of-medicines-and-active-substance-from-approved-countries?utm_source=e2cdee10-0fed-4e60-9dc1-47b1b908f674&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Regulating medical devices https://www.gov.uk/guidance/regulating-medical-devices-in-the-event-of-a-no-deal-scenario?utm_source=de04e7b7-9ef3-4d20-b1ca-0fac2e5944e1&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Webinars on submissions to the MHRA and use of new systems https://www.gov.uk/government/publications/how-to-make-regulatory-medicines-submissions-to-the-mhra-if-the-uk-leaves-the-eu-with-no-deal?utm_source=02db27e5-756f-4d67-9627-126158661eab&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Qualified persons responsible for pharmacovigilance (QPPV) https://www.gov.uk/guidance/guidance-on-qualified-person-responsible-for-pharmacovigilance-qppv-including-pharmacovigilance-system-master-files-psmf-if-the-uk-leaves-the-eu-w?utm_source=b231df6e-1f53-4d79-884e-e3efb8348454&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Contingency legislation covering regulation of medicinal products and medical devices https://www.gov.uk/government/news/contingency-legislation-covering-regulation-of-medicines-and-medical-devices-in-a-no-deal-scenario?utm_source=21ea0f1d-efbd-4eac-8fb7-5462c5b57310&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- MHRA consutation on legislative proposals https://www.gov.uk/government/consultations/mhra-consultation-on-eu-exit-no-deal-legislative-proposals?utm_source=20f0f36e-3a63-45fc-bdc1-8215eee0e6ac&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Exceptions and modifications to EU good pharmacovigilance practice https://www.gov.uk/government/publications/exceptions-and-modifications-to-the-eu-guidance-on-good-pharmacovigilance-practices-that-will-apply-in-a-no-deal-brexit?utm_source=89f0758d-3704-451e-adac-ab9f5eed1cb9&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Converting Parallel Distribution Notices to UK Parallel Import Licences https://www.gov.uk/guidance/guidance-on-converting-parallel-distribution-notices-pdns-to-uk-parallel-import-licences-pils-in-a-no-deal-scenario?utm_source=7effa142-3340-4d41-af0a-046606d979ef&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Reference medicinal products https://www.gov.uk/guidance/guidance-on-reference-medicinal-products-rmps-if-the-uk-leaves-the-eu-without-a-deal?utm_source=6d1b131d-68d2-4bcc-895b-abffdd6ad84d&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Registration of clinical trials for investigational medicinal products https://www.gov.uk/guidance/guidance-on-registration-of-clinical-trials-for-investigational-medicinal-products-and-publication-of-summary-results?utm_source=5558eb31-fd10-4eff-a8dd-9bf63b786796&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Handling of Decentralised and Mutual Recognition procedures https://www.gov.uk/guidance/guidance-on-handling-of-decentralised-and-mutual-recognition-procedures-in-a-no-deal-scenario?utm_source=88e334ff-23f6-4e5a-a54b-f69c8c4f7cbf&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Variations to marketing authorisations https://www.gov.uk/guidance/guidance-on-how-variations-to-marketing-authorisations-mas-will-be-handled-after-exit-day-if-the-is-no-deal?utm_source=510d59ba-a73f-4bf2-be9d-db9973333142&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Conversion of Community Marketing Authorisations to UK Marketing Authorisations https://www.gov.uk/government/publications/conversion-of-community-marketing-authorisations-to-uk-marketing-authorisations-letter-to-industry?utm_source=8b25bfbb-7e24-4b98-bc4e-bd73684e581b&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- List of approved countries for authorised human medicines https://www.gov.uk/government/publications/list-of-approved-countries-for-authorised-human-medicines-in-a-no-deal-scenario?utm_source=32ed8ebb-0bbc-421d-ae2f-9ca869d4a481&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Registering new packaging information for medicines https://www.gov.uk/guidance/updates-to-packaging-components-and-instructions-on-submissions-if-the-uk-leaves-the-eu-without-a-deal-for-those-marketing-authorisations-ma-issued?utm_source=d52522de-8d63-479f-9926-656d7f9e758e&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Marketing Authorisation applications when Member States had not been in agreement https://www.gov.uk/guidance/guidance-on-marketing-authorisation-applications-submitted-to-the-uk-that-have-been-referred-under-article-29-in-a-no-deal-scenario?utm_source=a60d8070-4656-41f8-a774-6a3425d5a750&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Pharmacovigilance procedures https://www.gov.uk/government/publications/guidance-on-pharmacovigilance-procedures-in-the-event-the-uk-leaves-the-eu-without-a-deal?utm_source=119cf6dd-0db3-46c2-be3c-82bba3401b1b&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- MHRA guidance and publications https://www.gov.uk/government/collections/mhra-guidance-and-publications-on-a-possible-no-deal-scenario?utm_source=b34c7d01-0615-49d1-9560-811ec5907a3c&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
GPhC whistleblowing report
Posted: Wednesday, September 18th, 2019
The 9 healthcare regulators have just published an annual report on the way whistleblowing disclosures have been dealt with. The aim of the report is to increase transparency in the way that whistleblowing disclosures are dealt with and to raise confidence among whistleblowers that their disclosures are taken seriously.
The GPhC’s section of the report records the following responses to whistleblowing disclosures received between 1 April 2018 and 31 March 2019:
Under review 7
Closed with no action taken 3
Onward referral to alternative body 1
Regulatory action taken 5
In addition, one disclosure received during the previous reporting period was concluded with guidance.
Equality Act and withdrawing pharmacy services
Posted: Friday, August 30th, 2019
In an article just published in Chemist & Druggist, David Reissner looks at the Equality Act implications of withdrawing pharmacy services. The article can be accessed here: https://www.chemistanddruggist.co.uk/opinion/legal-view-what-consider-stopping-free-deliveries-or-mds
GPhC Publication and disclosure policy in FtP cases
Posted: Sunday, August 25th, 2019
Last Summer, we responded to a GPhC consultation on its Publication and disclosure policy. The new policy has now been published https://www.pharmacyregulation.org/sites/default/files/document/gphc-publication-and-disclosure-policy-gphc0034-august-2019.pdf.
As well as setting out the GPhC’s new policy for publishing the reports of pharmacy inspections, the policy includes:
- Registrants will usually be told if a concern about their fitness to practise has been received unless the GPhC thinks telling the registrant would adversely affect an investigation.
- The identity of an informant will not be disclosed without the informant’s agreement.
- A registrant’s employer may be informed that a concern has been received if the GPhC thinks this is in the public interest.
- An informant will not routinely be informed of the registrant’s response to any request for information, but it may be disclosed on a case-by-case basis. An informant will be informed of the outcome of an investigation.
- Fitness to Practise Committee decisions will be searchable on the GPhC website for 12 months if a registrant’s fitness to practise has been found to be impaired. (This does not include health cases or cases where an interim order has been made, because these cases are heard in private.)
- Varying lengths of time a Fitness to Practise determination appears on the online register. In the case of removal, the period will be 5 years and (the person’s entry on the register showing that they have been removed will remain for 10 years). In the case of suspensions, the determination will appear on the online register for the period of suspension plus 2 years.
Court rules on whether there is a right to silence in Fitness to Practise proceedings
Posted: Thursday, August 15th, 2019
In The Queen (on the application of Evgeniy Kuzmin) v GMC  EWHC 2129 the High Court addressed the question of whether a medical practitioner had a right to silence when appearing before the Medical Practitioner Tribunal and whether adverse inferences could be drawn from silence. As explained below, the significance of the case is not limited to proceedings involving medical practitioners.
Dr Kuzmin was working for an out-of-hours service. He was accused, amongst other things, of poor record keeping. Pending a final hearing, conditions were placed on his registration. These conditions included a requirement to notify any out-of-hours service of the conditions. Dr Kuzmin did not notify an employer of the conditions. No misconduct was found in relation to the original allegations, but it was alleged that the failure to notify the out-of-hours service of the conditions on his registration was misconduct.
In fitness to practise proceedings before the Medical Practitioner Tribunal, Dr Kuzmin filed a written statement, strenuously denying dishonesty and said that any failure was a “complete oversight”. At the conclusion of the GMC’s presentation of its case, Dr Kuzmin’s barrister submitted that there was no case to answer. That submission was unsuccessful. Dr Kuzmin then withdrew his statement and declined to give evidence.
The GMC argued that the Tribunal could draw an adverse inference from the refusal to give evidence and that there was no innocent explanation for the doctor’s failure to inform the out-of-hours service of the conditions imposed on his registration. The Tribunal decided it could draw inferences from silence. The case was then adjourned so that Dr Kuzmin could apply to the High Court for judicial review.
The High Court (Lord Justice Hickinbottom and Mr Justice Butcher) held:
- Disciplinary proceedings are civil, not criminal proceedings (in which a defendant has different rights and protections);
- Ordinarily the public would expect a professional man to give an account of his actions – there is no right to silence in disciplinary/fitness to practise cases;
- It would not be unfair if the possibility that an adverse inference might be drawn makes a healthcare professional feel obliged to give evidence;
- Whether an adverse inference is drawn in any particular case will be “highly dependent upon the facts of the particular case”;
- No inference will be drawn unless:
- a prima facie case to answer has been established;
- the individual has been given appropriate warning that if he does not give evidence than an inference may be drawn; and an opportunity to explain why it would not be reasonable for him to give evidence, and, if it is found that he has no reasonable explanation, an opportunity to give evidence;
- There is no reasonable explanation for his not giving evidence;
- There are no other circumstances in the particular case which would make it unfair to draw such an inference.
The significance for pharmacists and other healthcare professionals
The significance of this decision is not limited to cases against medical practitioners. The Court cited an earlier judgment concerning a pharmacist - R (Panjawani) v Royal Pharmaceutical Society of Great Britain  EWHC 1127 (Admin) as authority for its decision (1) that there is no right to silence in professional disciplinary proceedings; and (2) that adverse inferences can be drawn from silence in proper circumstances. That was a case in which a pharmacist was accused of failing to account for a quantity of Viagra, but had failed to explain what had become of it. In fact, the pharmacist successfully argued that an adverse inference should not have been drawn because the regulator had never given him a proper opportunity to explain what had happened to the Viagra.
The recent Kuzmin case is also of importance to all healthcare professionals because Lord Justice Higginbottom suggested it might be useful for all healthcare regulators to give guidance on the existence of the power to draw adverse inferences and how it might be used in fitness to practise cases.
Hub & Spoke - change to pharmacy law announced
Posted: Tuesday, July 23rd, 2019
In its announcement yesterday of a new funding package for community pharmacy, the Governement also announced that it will will "pursue legislative change to allow all pharmacies to benefit from more efficient hub and spoke dispensing, enabling increased use of automation and all the benefits that that brings".
The Government also proposes to amend the NHS market entry regulations to make it easier for two pharmacies to merge and then close one of them with less risk that someone else will apply for a new pharmacy "contract" to replace the one that closed.
Annual GPhC Fitness to Practise report
Posted: Monday, July 15th, 2019
The General Pharmaceutical Council has published its annual Fitness to Practise report. Amongst other things, the report contains the following information:
By far, the biggest source of concerns came to the GPhC from members of the public – 1439 out of 2,674 (an increase of 345 on the previous year).
167 concerns came from employers, 264 came from inspectors and 360 from other healthcare professionals.
Overall, 1,027 cases were closed at the triage stage in 2018/19 (39% of all concerns raised) compared with 791 in 2017/18 (34% of all concerns raised). The reduction may be the result of using more senior oversight, and the GPhC is currently evaluating the impact of adding more senior oversight into the triage process.
736 cases ended with a letter of advice, and of those that went to a Fitness to Practise Committee hearing the sanctions were –
37 suspensions from the register
13 removals from the register.
Promoting professionalism, reforming regulation – the Governments’ consultation response
Posted: Thursday, July 11th, 2019
The UK Government and the devolved governments have published their response following their consultation on promoting professionalism and reforming the regulation of healthcare professionals - https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/815261/promoting_professionalism_reforming_regulation_-_eds_HW.pdf.
The structure of healthcare regulation and regulatory bodies
The original consultation paper suggested that there should be some rationalisation of the 9 current healthcare regulators. However, opinions in the responses from consultees were divided and the governments say more work needs to be done on this, so there will be a further consultation. Regardless of the outcome of the further consultation, there will be structural changes to all the healthcare regulators. Their councils will become boards which comprise executive and non-executive directors, appointed on the basis that they have the skills, knowledge and expertise to ensure the regulator discharges its functions effectively. The non-executive directors will always form the majority of the board. Current and former registrants may be appointed to the board, but they will not form a majority. The governments have dropped a proposal for employers to be represented on the regulatory bodies' board, but expects regulatory bodies to actively seek and consider the views of employers.
Fitness to practise processes
The governments say the aim of reform is “to enable the regulators to place a greater emphasis on supporting the professionalism of all registrants, while continuing to take appropriate action to manage concerns about a minority of professionals…At the heart of these changes is the much-needed modernisation of fitness to practise processes.”
The governments believe that regulatory bodies manage complaints about professionals in a largely reactive way, focussing much of their effort and resources on managing concerns about a minority of registrants at the expense of supporting the professionalism of the majority. Investigations into allegations will, they say, always be central to delivering public protection. However, they regard these processes as
“bureaucratic and lengthy, which can be frustrating and stressful for patients and their families, registrants and employers. They are also legalistic and adversarial, and this can be detrimental to the development of a learning culture. Fitness to practise concerns need to be handled in a timely, efficient and proportionate manner to ensure safe, high quality healthcare delivery”.
Future processes will be “more collaborative and less adversarial”, and there will be requirements to update patients and family members on the progress of fitness to practise cases in which they have an interest.
New FtP powers
The most significant changes will enable regulators to resolve fitness to practise cases without the need for a full panel hearing where it is appropriate to do so.
Regulators will be able to:
- use case examiners to consider complaints and, where appropriate, resolve them on a consensual basis;
- include mediation as part of their fitness to practise processes if they wish; and
- remove registrants from the register automatically where they have been convicted of a very serious criminal offence – murder, rape or sexual offences involving children - in the UK.
Regulators have an existing duty to co-operate and the governments will explore whether this needs to be strengthened to enable them to work even more closely together with one another and with other organisations in the health and care system in the exercise of their functions.
The GPhC has published its response to the governments’ conclusions which you can read here: https://www.pharmacyregulation.org/sites/default/files/document/gphc_response_to_promoting_professionalism_reforming_regulation.pdf
These news items are not exhaustive but are selected according to their relevance to pharmacy practice, NHS community pharmacy contracts and the regulation of the pharmacy profession. If you wish to add any items that you think we have missed, contact our news editor.