EU-5 has become EU-4! What happened to the UK?

Webinar description

Focus on the EU5: that is the geographical scope we have become used to identifying market opportunities and preparing the ground for orphan drug launches. After all, these 5 countries (France, Germany, Italy, Spain and UK) represent approximately 80% of potential healthcare spend in rare diseases in Europe and are duly prioritised by pharma companies.

Now we are hearing requests for a different geographical scope when pharma is planning launches for orphan drugs and ATMPs: “Focus on the EU5” or more recently, “Focus on the EU4”. So what has happened to the UK?

This webinar will set out two opinions: the first for including the UK as a priority market when developing launch strategies for orphan drugs and ATMPs; the second against including the UK as a strategic priority. By effectively exploring different arguments, the listener will get an objective perspective as to the value of UK prioritisation in developing orphan drugs and ATMPs launch strategies.

On 1st Jan 2021, the UK officially left the European Union. In advance of this, UK politicians and agencies were preparing to ensure the UK remained a country for investment by the pharmaceutical industry. The Life Sciences Industrial Strategy was set up as a collaborative program to address potential gaps and work towards a ‘more efficient and effective health system’.

In addition to this, the UK regulator, MHRA, set up an Innovative Licensing and Access Pathway (ILAP) in Jan 2021. Just one month later, the MHRA was keen to announce the first ILAP given to a rare cancer drug. NICE is also looking to ensure it remains cutting edge in the world of HTAs (and is currently undergoing a new review of its appraisal methodology) and is currently consulting various stakeholders with a revised process due later this year. The appraisal review is part of NICE’s 5-year ambitious strategy from 2021-2026.

A recent study showed that less than half of orphan drugs are routinely funded by the English National Health Service (NHS) -1. The funding is ‘helped’ to a certain extent by Specialised Commissioning and the Cancer Drugs Fund. The same study showed access to orphan drugs is the lowest in the EU5: compare Germany at 93% and France at 81%. Another study found the UK is ~1.5 times lower than Germany, France or Italy when considering the per capita Euro spend on prescription drugs – 2. Add Brexit into the mix and perhaps it is not surprising that over 80% of our last requests for orphan drug launch support have excluded the UK as a strategic priority.

REFERENCE 1   2 Patient Access to Medicines for Rare Diseases in European Countries – ScienceDirect


    Sophie Schmitz

    Managing Partner at P4A
    Sophie is Managing Partner at Partners4Access (P4A), a global consultancy 100% focused on orphan drug access. P4A support the biotechnology and pharmaceutical industry along their launch journey to help secure successful price, reimbursement and access for orphan drugs. The company has solid partnerships with clients supporting their strategy and operations to effectively ensure launch success.

    Sophie has worked in a range of disease therapy areas and has industry experience in both medical device and pharmaceutical industries, as such she has developed a solid appreciation of strategic challenges and opportunities facing companies. Through her time in industry, she worked on several key product launches in both strategic planning and implementation. She has worked in global, regional and local teams which gives her a strong appreciation of real-life challenges in modern day healthcare organizations.

    Sophie’s has enjoyed a successful 20-year commercial career within consultancy and industry. Prior to setting up Partners4Access, she worked at Alliance, PriceSpective, BMS, ConvaTec, SSL International and Smith & Nephew. In this time, Sophie has been involved in several product launches, organizational changes and acquisitions.

    Akshay Kumar

    Akshay is a Partner at Partners4Access. He has 13+ years of experience helping pharmaceutical and biotech companies develop market access & pricing solutions – which are aligned to their broader commercial, organisational and environmental context. These solutions could be at the product, process and/or capability level. Besides market access, Akshay also has supported pharmaceutical companies in allied commercial areas such as – epidemiology, opportunity assessments, product positioning, product performance tracking, customer insights, and organisational design.

    Prior to joining Partners4Access, Akshay worked at Huron Consulting and ZS Associates, including secondments at Allergan Europe, Bayer and GSK. During this period he has been involved in supporting over 30+ orphan and specialty drugs with their global value communication needs.

    Akshay has a PhD in materials science and masters degrees in business management and engineering.

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