Katya Farkas

Subscribe to Katya Farkas's Posts
Contact:Read more about Katya Farkas

UK Prime Minister Kier Starmer announced yesterday that NHS England will be abolished to “cut bureaucracy” and bring management of England’s health service “back into democratic control”. NHS England will be brought back into the Department of Health and Social Care (DHSC) over the next two years.

The Government aims to remove a “burdensome layer of bureaucracy” and “put an end to the duplication resulting from 2 organisations doing the same job”. In doing so, the intention is to save hundreds of millions of pounds, enabling funds to be channelled towards enhancing patient care, reducing waiting lists and increasing staff salaries.  However, exactly how this will be done and what impact this will have on patients, staff and the many partners of the NHS in England, including pharmaceutical companies, is not yet known.Continue Reading UK Prime Minister Announces that NHS England will be abolished

The UK’s General Pharmaceutical Council (GPhC) has published new guidance for registered pharmacies providing pharmacy services at a distance, including on the internet. The GPhC is the pharmacy regulator for Great Britain. Pharmacies and pharmacists, including those operating online, are required to be registered with GPhC and follow the standards it sets.

The prevalence of online pharmacies, “telemedicine” or “telehealth”, has rocketed in recent years and they provide a valuable service. However, cases have been identified where medicines were supplied inappropriately, and people were put at risk. As such, the guidance introduces enhanced safety measures whereby prescribers must take additional steps to ensure the information that a person provides in order to obtain medicines from an online pharmacy is accurate. Notably, medicines categorised as “high-risk” should not be prescribed based on an online questionnaire alone. Pharmacies are required to ensure that their own prescribers meet the requirements and, where they are dispensing product prescribed online by a third-party prescriber, ensure that those prescribers operate in accordance with the guidance.

The guidance covers risk assessments, record keeping and audits, the empowerment of staff and suitable facilities and equipment. However, this blog focuses on the requirements of the digital platform, compliance with laws, the online consultation process, enhanced requirements for “high risk” medicines and working with third-party providers.Continue Reading Online pharmacies required to strengthen safeguards to prevent unsafe supply of medicines in the UK

As set out in our previous post, the Innovative Licensing and Access Pathway (ILAP) is an initiative aimed at bringing innovative medicines to the UK market more quickly. On 30 January 2025, the MHRA launched a new version of ILAP in response to feedback from stakeholders.

The first version was launched in January 2021, shortly after the end of the Brexit transition period. It enabled developers to work collaboratively with the NHS, MHRA, and UK Health Technology Assessment (HTA) bodies to bring their product to the UK market in a more streamline and efficient way, benefiting from tailored guidance and support as well as shorter timelines. The scheme saw high levels of applicants, but also faced criticism from stakeholders for a lack of clarity, overly permissive entry criteria and a lack of direct NHS involvement.Continue Reading The new UK Innovative Licensing and Access Pathway – relaunched, refined, refreshed

Do discount campaigns on prescription-only medicines (POMs) run by mail order pharmacies lure patients into consuming medicinal products?

Advocate General Szpunar has opined that they do not. The opinion comes in the latest of a stream of cases on advertising practices involving DocMorris (Case C-517/23), a Dutch mail-order pharmacy that supplies medicines to end customers in Germany. The AG concluded that the discount campaigns regarding POMs do not fall within the definition of “advertising of medicinal products” (Article 86(1) Directive 2001/83) as the discount is implemented at the point of purchase of the POM.  The decision of which product to prescribe has already been taken by a doctor and all the patient is left to do is choose the dispensing pharmacy. As such, the purpose of the discount campaign is not to encourage patients to purchase medicinal products. Rather, it is simply to attract them to a specific pharmacy.Continue Reading When discount campaigns regarding prescription only medicines do not fall within the definition of advertising in the EU

On 23 September 2024, the Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) published an updated Code of Practice for the pharmaceutical industry. Following an extensive consultation with over 3,000 comments, ABPI has announced that the new “orange” 2024 Code amends the previous 2021 Code in three key areas: the PMCPA constitution and procedure; the provision of prescribing information; and certain elements of the Code moving from guidance to mandatory requirements. However, there are also interesting amendments to the requirement to maintain high standards and obligation to seek a lawful basis for disclosure of transfers of value to an individual.

ABPI has said that the new Code seeks to “raise the high standards expected of pharmaceutical companies even further while also ensuring that complaints can be resolved quicker”.Continue Reading A New 2024 Code for the British Pharmaceutical Industry  – “The Future is Orange”

On 26 January 2023, the Prescription Medicines Code of Practice Authority (the PMCPA) published long-awaited Guidance on Social Media 2023 (the Guidance). While a Digital Guidance note, which covered certain issues arising from use of social media, was published by PMCPA in 2016, the large number of complaints since that time is evidence of continued uncertainty regarding permitted activity in this area.    

However, while the Guidance acknowledges the challenges introduced by the “open and transitory” nature of social media, it broadly reflects recent PMCPA decisions and rejects the more permissive approach that some stakeholders had advocated was appropriate.  Nevertheless, the additional clarity provided by the Guidance is welcome and, by defining general principles applicable to use of social media and issuing more detailed guidance in certain areas, PMCPA has provided a framework to assist companies in managing their social media activity going forward. Continue Reading UK PMCPA publishes long-awaited guidance on use of social media

As we have discussed in previous posts, at the end of 2020, the European Commission set out its vision to build a European Health Union with its announcement of the new pharmaceutical strategy for Europe (the new Strategy). In 2021, the Commission has begun to implement the new Strategy, as discussed here. One area that was identified as in need of revision was the unmet medical needs in areas currently not within the scope of the legislation governing rare diseases and paediatric medicines. The Commission has been focused on this area for a number of years, and there have been a number of consultations and stakeholder engagements to explore possible changes to the legislative regime. We set out below a summary of the Commission’s proposals on orphan and paediatric medicinal products.

Continue Reading European Commission’s proposed amendments to orphan and paediatric legislation

In a report published on 16 July regarding the implementation of its flagship policy on the publication of clinical data (Policy 0070), the EMA has announced that Brexit and the Agency’s relocation will result in some areas of work being “temporarily reprioritised, suspended or postponed to resource Brexit preparedness activities and safeguard…

On 27 June 2018, the EMA published a short notification on its website informing readers that “The Agency is no longer in a position to process access to documents requests issued from outside the EU.”

Article 2(2) of Regulation (EC) No 1049/2001, setting out the EU legislative framework for freedom of information (the Public Access Regulation), provides EU institutions with the discretion to disclose to individuals from third countries documents they have drawn-up or received, provided the conditions of such access are no less restrictive than that provided to EU citizens under Article 2(1) of the same regulation. This change in policy means that only “Citizens of the EU and natural or legal persons residing or having their registered office in an EU Member State have the right of access to EMA documents.”
Continue Reading Update to the EMA’s Position on Access to Documents