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
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.
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.
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 Voluntary Pricing and Access Scheme (VPAS)
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 VPAS (formerly the PPRS), which caps the growth in the medicines bill, tendering administered by the NHSE Commercial Medicines Unit, to secure significant discounts, and Patient Access Schemes (PAS) which involve significant discounts on new medicines (60 percent of NICE Guidance includes a PAS).
EMIG supports the stated aims of the VPAS which are to:
improve patient access to medicines by getting the best value and most effective medicines into use more quickly
keep the branded medicine bill affordable for the NHS through a cap in growth of branded sales
support innovation and a successful life sciences industry in the UK
Better Research for Better Outcomes
EMIG believes that improved access to medicines for patients in the UK can be achieved through inputs into UK HTA health technology assessments which reduce uncertainty and improve product value propositions
EMIG has established a collaborative initiative, ‘Better Research for Better Outcomes’ that seeks to create the conditions that facilitate the generation of a package of evidence capable of satisfying both regulatory and HTA bodies.
This will establish a win-win:
Driving inward investment
Addressing some Brexit issues/risks
Optimising NIHR funding and funding from medical research charities
Making the UK the standout country for market access
Helping the NHS buy outcomes and not costs
Supporting patients to live longer and with a better quality of life.
EMIG believes that all stakeholders have an interest and therefore a shared responsibility to work towards better research to achieve better outcomes.
EMIG proposes the following action plan for a sustainable and long-term solution for better patient access to medicines in the UK
Develop a UK value framework for better research
Make NICE Scientific Advice a mandatory part of a NICE appraisal
NIHR funding and the badging of academic (NCRI) clinical studies to incentivise generation of data to support regulatory and HTA submissions, as well as academic end points
Establish key performance indicators and incentives by creating a specific commissioning pathway for the results of academic studies that shows the contribution to regulatory or HTA approvals
Support the concept of ‘hybrid’ trials where academic and commercial agendas converge
Incentivise innovative academic clinical trial designs for the UK to become the world-leader in trial design
Create agile and flexible treatment algorithms that optimise treatments, drive clinical innovation and create choice for patients within a resource constrained model
Enable and design flexible approaches to pricing and to patient access schemes
Shorten the time between regulatory approval, HTA and adoption by the NHS
The Pharmaceutical Industry & the NHS
EMIG is committed to having a constructive and productive two-way relationship with the NHS. We believe that some of the ‘efficiency proposals’ set out in the Five Year Forward View seek to unnecessarily restrict industry’s engagement with the NHS. We propose the establishment of a New Medicines Fund in order to mitigate concerns and improve patient access to innovative medicines.
The NHS and industry are interdependent. 90% of all interactions between a Health Care Provider (HCP) and a patient result in the prescription of a medicine.
There are many examples of strong relationships between individuals on both sides, founded on trust that have been developed over many years. Yet NHS England appears intent on controlling engagement between the NHS and industry in order to limit spending on medicines. The Next Steps on the Five Year Forward View has determined that:
Formulary decisions will now typically be made by Regional Medicines Optimisation Committees (RMOC) rather than by each CCG. A complex committee arrangement is envisaged that is informed only by horizon scanning. Not all medicines will be identified by horizon scanning processes which focus on new molecules. Many ‘new’ medicines can be combinations of existing medicines, adaptations such as modified release presentations, or medicines that are new to the UK market, having been available in other countries.
There is no engagement or appeals process for industry.
In addition NHS Improvement will be supporting hospitals to save £250 million from medicines spend in 2017/18 by publishing and tracking the uptake of a list of the top ten medicines savings opportunities.
While EMIG rrecognises the unprecedented financial challenges the NHS is facing and the many demands placed on it., we believe that the Five Year Forward View has overlooked the fact that relationships between industry and the NHS are also built upon translational medical research and the development Real World Data
We propose the setting up of a New Medicines Fund, delivered through the negotiation of the 2019 PPRS. The Fund would
be supported by continued industry rebates (estimated to be £3billion in the lifetime of the current Scheme)
pay for all new medicines launched during the period of the Scheme
properly finance medicines approved under the Early Access to Medicines Scheme (EAMS)
support those recommended by the four new Regional Medicines Optimisation Committees (RMOCs)
be a hypothecated fund, separate from other NHS budgets, and
all decision making and funding would be transparent, supported by an effective appeals process.