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Our Work 2017-11-11T18:20:44+00:00

Leadership in life sciences – our priorities

There are several key environmental factors that influence the life sciences’ market attractiveness. Among these the UK has global leadership in real world evidence and data science, and world-class capabilities across the spectrum of life sciences research. We fall short, however, when it comes to adoption and efficient diffusion of ‘value-shown’ innovative medicines and health technologies by the NHS.  EMIG believes that Brexit negotiations must work to enhance the UK’s leadership in research, while identifying new opportunities to accelerate access for patients. To do this Government should:-
  • Establish a whole system perspective among all Government departments
  • Ensure that stability and predictability are key principles upon which discussions are based
  • Agree clear negotiation goals with the all the representative bodies of the industry

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  • Set ambitious objectives for the future of MHRA as a world-leading regulator:
    • Creating a framework through which mutual recognition of EMA decisions and actions is possible
    • Enabling new partnerships with other national regulatory bodies such as the FDA
    • Encouraging the development of new policy and regulatory processes suitable for the latest developments in science and innovation.
    • Revising the scope of EAMS to include drug and device combinations, cell therapies and genetic treatments;  simplifying its operation and set adoption requirements for NHSE.
    • Adopting a mindset to minimise the bureaucratic burden on industry.
  • Reinvest a proportion of the savings from future EU rebates into the Biomedical Catalyst
  • Continue EU collaborations in academia and research bodies
  • Taking a positive approach to immigration than enables mobility of talent in and out of the UK
  • Ensuring access to the single market for medicines
  • Investing in an ambitious and holistic programme of marketing the UK life sciences sector overseas

EMIG is a member of The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), founded in 2008 to represent companies and associations active in research, development, production and distribution of pharmaceutical products; EUCOPE seeks to enhance their scientific, technical, economic and legal objectives across Europe.

Visit the EUCOPE website

Leadership in Life Sciences – enhancing regulation post Brexit

EMIG believes there are opportunities for enhancing regulation of medicines post Brexit
  • All regulation of pharmaceuticals, except pricing and access, is administered at EU level; namely licensing, PV and clinical trials.
  • EMIG believes the UK should seek a Mutual Recognition Agreement (MRA) with the EU, similar to that held with Switzerland, Canada and Australia, while also having the ability to introduce national processes where improvements are needed.
  • This could include:
    • Decreasing the bureaucracy associated with the Clinical Trials Directive leading to faster start up times and making the UK more competitive for the placement of trials.
    • Aligning regulation of medicinal products and medical devices to enhance clarity for products at the borderline between the two.
    • Aligning regulation of companion diagnostics.
    • Simplifying regulation of Advanced Therapy Medicinal Products.
    • Establishing a national regulatory policy to allow RWE (real world evidence) to be used to support registration.
    • Enabling MHRA  to continue its role as a leading global regulatory body.
    • Redesigning the EAMS process by removing the constraints of EU regulation so that MHRA can design bespoke arrangements that are more enabling and attractive to global pharmaceutical companies, as well as leading to faster access for patients.
    • Exploring new licensing approaches fit for the new generation of therapies being developed – particularly cell and gene editing, as in the US and Japan.

The 2019 PPRS

There are popular misconceptions about the pharmaceutical industry, particularly with regard to pricing – or ‘list prices’- that are often perceived to be high. In the UK there are three main routes the Government uses to control pricing: the PPRS, which caps the growth in the medicines bill, tendering administered by the NHS Commercial Medicines Unit, to access significant discounts, and Patient Access Schemes which involve significant discounts on new medicines (60 percent of NICE Guidance includes a PAS).
EMIG supports the stated aims of the PPRS which are to:
  • Provide stability and predictability to the Government and the industry.
  • Support the NHS by ensuring that the branded medicines bill stays within affordable limits.
  • Improve access to innovative medicines commensurate with the outcomes they offer patients by ensuring that medicines approved by NICE are available widely in the NHS.
  • Reduce bureaucracy and duplication.
  • Support the Government’s growth and innovation agenda for life sciences.

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In order to fully meet these goals and enable the NHS to afford new, innovative medicines, EMIG believes the next Scheme, due to start in 2019, should
  • Included accountabilities for increasing pharmaceutical investment in R&D, and rewards for the creation of high value employment.
  • Introduce a New Medicines Fund, sponsored by continued industry rebates, that would pay for, inter alia, all new medicines launched during the period of the Scheme.
  • Restore the PPRS ‘Taper’ with a higher exemption threshold of £10m, and applied to companies with up to £40m in annual turnover.

Better Research for Better Outcomes

EMIG believes there are opportunities for enhancing regulation of medicines post Brexit
  • All regulation of pharmaceuticals, except pricing and access, is administered at EU level; namely licensing, PV and clinical trials.
  • EMIG believes the UK should seek a Mutual Recognition Agreement (MRA) with the EU, similar to that held with Switzerland, Canada and Australia, while also having the ability to introduce national processes where improvements are needed.

Save

Save

Save

Save

Save

  • This could include:
    • Decreasing the bureaucracy associated with the Clinical Trials Directive leading to faster start up times and making the UK more competitive for the placement of trials.
    • Aligning regulation of medicinal products and medical devices to enhance clarity for products at the borderline between the two.
    • Aligning regulation of companion diagnostics.
    • Simplifying regulation of Advanced Therapy Medicinal Products.
    • Establishing a national regulatory policy to allow RWE (real world evidence) to be used to support registration.
    • Enabling MHRA  to continue its role as a leading global regulatory body.
    • Redesigning the EAMS process by removing the constraints of EU regulation so that MHRA can design bespoke arrangements that are more enabling and attractive to global pharmaceutical companies, as well as leading to faster access for patients.
    • Exploring new licensing approaches fit for the new generation of therapies being developed – particularly cell and gene editing, as in the US and Japan.

The Pharmaceutical Industry & the NHS

There are popular misconceptions about the pharmaceutical industry, particularly with regard to pricing – or ‘list prices’- that are often perceived to be high. In the UK there are three main routes the Government uses to control pricing: the PPRS, which caps the growth in the medicines bill, tendering administered by the NHS Commercial Medicines Unit, to access significant discounts, and Patient Access Schemes which involve significant discounts on new medicines (60 percent of NICE Guidance includes a PAS).
EMIG supports the stated aims of the PPRS which are to:
  • Provide stability and predictability to the Government and the industry.
  • Support the NHS by ensuring that the branded medicines bill stays within affordable limits.
  • Improve access to innovative medicines commensurate with the outcomes they offer patients by ensuring that medicines approved by NICE are available widely in the NHS.
  • Reduce bureaucracy and duplication.
  • Support the Government’s growth and innovation agenda for life sciences.

Save

Save

Save

Save

Save

Save

Save

Save

Save

Save

Save

In order to fully meet these goals and enable the NHS to afford new, innovative medicines, EMIG believes the next Scheme, due to start in 2019, should
  • Included accountabilities for increasing pharmaceutical investment in R&D, and rewards for the creation of high value employment.
  • Introduce a New Medicines Fund, sponsored by continued industry rebates, that would pay for, inter alia, all new medicines launched during the period of the Scheme.
  • Restore the PPRS ‘Taper’ with a higher exemption threshold of £10m, and applied to companies with up to £40m in annual turnover.