Press Releases

16.9.11

EMIG Members vote by massive majority to appoint Dr Mark Edwards as R&D Director

EMIG Chairman, Leslie Galloway, expressed his delight at the level of support for the Steering Group proposal to appoint Dr Mark Edwards as R&D Director. Mark has extensive R&D experience and is well respected by the NHS and academia.

Mark will now start work profiling EMIG Members' R&D needs while setting up collaborative arrangements between Member companies and the appropriate institutions. The overall aim is to reverse the downward trend of dis-investment and to stimulate innovation in the UK.    

15.3.11

EMIG calls for a collaborative approach on Value-Based Pricing (VBP) for medicines

The Ethical Medicines Industry Group (EMIG) has today called on the Government to work with the whole Pharmaceutical Industry and patient groups to devise a transparent engagement strategy in the development of its model for Value-Based Pricing. EMIG is the biopharmaceutical trade association that represents the interests of over 135 small to medium-sized companies (SMEs).

In its submission to the Government's consultation A new value-based approach to the pricing of branded medicines EMIG stated its support for the broad objectives of the consultation. However, EMIG urged the Government to work with the whole industry to create a system which rewards and incentivises the development of medicines that produce real benefits to patients and ensures that the UK remains a competitive science base by overcoming delays in the uptake of new medicines.

EMIG Chairman Leslie Galloway said: "The development of a new pricing and reimbursement scheme, based on the core principle of tightening the link between the price the NHS pays and the value that a medicine delivers to patients, is complex.

"EMIG looks forward to working closely with the Department, our industry colleagues and patient groups to design and implement a pricing model that brings the best possible outcomes for patients, value to the NHS and continues to support the pharmaceutical industry in innovation and research"

EMIG is calling on the Government to:

EMIG has some concerns with elements of the consultation which are outlined in our full response, namely the sole use of the QALY assessment which has been suggested will become the basis for the development of the cost effectiveness threshold element of Value-Based Pricing. EMIG believes that other options need to be considered when assessing value of medicines for rare diseases, for example.

EMIG believes that those responsible for attributing, designing and developing the processes of assessment for the new value system should include health professionals experienced in treating the particular illness, patients and relevant patient groups. EMIG would welcome the opportunity to work with Department and industry colleagues to help define the possible measures for assessment.

 

4.2.11 EMIG reaches 130 members. 

 

18.1.11 Cancer Drugs Fund Should Not be a Precursor to Value Based Pricing

The Ethical Medicines Industry Group (EMIG) welcomes the creation of a Cancer Drugs Fund and supports any initiatives which improve access to life changing or life saving medicines and therapies.  In responding to the Government's consultation on the creation of a fund designed to improve access to cancer medicines, EMIG called on the Government to:

Leslie Galloway, Chairman of EMIG said today "We believe that the Cancer Drugs Fund is a positive step which will help to address deficiencies in the current system for cancer patients. However, these deficiencies can also be seen to exist in other disease areas, and it is important that monies allocated to this Fund should not be at the expense of, or lead to, a loss of focus on the need for access to life-changing therapies for other conditions."

 "The patient/clinician relationship is fundamental. EMIG supports the objective of the Fund to provide patients with access to the medicines their clinicians agree are needed to extend or improve life. If the clinician thinks that a treatment will be of benefit to a patient, then EMIG believes the Fund should cover it"

However, EMIG is concerned that the Fund is being considered as a forerunner or pilot for the development of a value-based pricing system for pharmaceutical products to replace the current pharmaceutical pricing mechanisms by the end of 2013. The Cancer Drugs Fund should be seen as an approach to addressing access to medicines issues rather than a mechanism for determining price.

 

Response from EMIG to the NHS White Paper, Equity and Excellence: Liberating the NHS 5th October 2010

The Ethical Medicines Industry Group (EMIG) is the pharmaceutical trade association in the UK that represents the interests over 110 small to medium-sized companies. EMIG member companies range from start-ups, whose prime focus is research and development (R&D), to highly developed businesses delivering essential products to patients, while continuing to invest heavily in the fight against disease. 

 

Executive Summary

EMIG welcomes the opportunity to respond to the NHS White Paper, Equity and Excellence: Liberating the NHS, and the principles set out in the strategy to put patients first, improve health outcomes, increase accountability and autonomy and cut bureaucracy within the heath service.  As such, we have chosen to shape our response to the White Paper based on these broad areas of reform. As the trade body representing small and medium sized pharmaceutical companies we believe that our industry can play an enhanced role in helping to support and deliver the proposed reforms in healthcare. Any commissioning of the private sector should reflect transparency and open competition.

The EMIG response focuses only on the areas where our expertise is such that we have a unique contribution to make and where we are qualified to work in partnership with Government to develop the policy thinking on these aspects of healthcare reform.  We are making one overall response submission and this will address some of the questions raised in the four supporting consultations published by the Government.

The rich blend of businesses represented by EMIG enables us to uniquely understand and address the myriad of challenges facing pharmaceutical innovation and commercialisation in the UK. EMIG aims to support the work of the Government through its involvement in the Department of Health's Quality, Innovation, Prevention and Productivity (QIPP) agenda and the Department for Business Innovation and Skills' Office for Life Sciences (OLS). Through all our work with Government, we seek to ensure that medicines are seen as part of the solution, and not part of the problem, in the NHS. We firmly believe that better access to treatments will ensure better outcomes for patients and contribute to efficiency and effectiveness in the NHS.

The changes outlined in the White Paper are the most far reaching reforms to the NHS for many years and change itself is likely to be one of the greatest challenges to implementation. The scale of the proposed changes is enormous and these changes must be undertaken whilst the NHS continues to provide healthcare to millions of people.  EMIG believes it has an important contribution to make in working with the NHS and Department of Health to ensure that during this period of transition the standards of care, decision making and information are not compromised.

 

1 - Liberating the NHS

EMIG Position

EMIG supports the reduction of unnecessary management and bureaucracy within the NHS as a high priority.  Improving efficiency and effectiveness is critical to delivering an improved health service. EMIG is already working towards this goal through our work with Jim Easton and Mark Wilkinson to identify potential partnerships between industry and the NHS in line with the principles of QIPP.  One such example is a proposal to improve the quality of life for patients with Parkinson's disease through more efficient use of APO-go Therapy. This highly specialised, extensive and expensive Package of Care, builds on current recommendations set out by the National Institute for Clinical and Health Excellence's (NICE) clinical guidelines for diagnosis and management in primary and secondary care for patients with this condition. 

We also look forward to understanding more about the development of the Public Health Service and in particular the role of the new Public Health Directors which are proposed for Local Authorities. EMIG welcomes the reduction of barriers between health and social care. We are cautious, however, as to how this will work in practice.  We have a number of questions regarding social care budgets and how an already overburdened NHS would be able to absorb any shortfall in care. Of course we do not want to presuppose the conclusions of the Government's Commission on the Funding of Care and Support but would welcome the opportunity to discuss some of the challenges associated with proposals in the White Paper.

EMIG Proposal

 

2 - Putting Patients First

EMIG Position

Giving patients more choice and information about the possible treatments and services available to them for different conditions is at the heart of EMIG's beliefs and we support the principles of improved choice and information for patients and their carers.  We would urge the Government to ensure that this is a true choice for patients and not one that benefits particular treatments or care because of cost implications.  Some groups of patients are going to be able to make better informed decisions because of the particular care pathway involved in their conditions where as others will be at a disadvantage.

With regards to the information which will be made available to patients, and the role for industry in providing that, EMIG looks forward to the publication of the Government's Information Strategy consultation and will respond to this. Our members are very supportive of as much information being made available to both healthcare professionals and patients to aid in the shared-decision making process and look forward to seeing more details on this in due course.

EMIG Proposal

EMIG wishes to work with Government and healthcare providers to improve the information provided to patients and help improve treatment pathways.

 

3 - Improving Health Outcomes

EMIG Position

The White Paper sets out a number of proposals for the introduction of new frameworks specifically designed to measure outcomes, including the development of Quality Standards by NICE and the new Outcomes Framework.  A key issue of concern for EMIG members is the role the existing regulatory framework might play in determining such outcome measures and the ability of NICE to manage the production of over 150 quality standards over the next three years.  The time lag between marker authorisation and patient access to medicines in the NHS, as a result of the current speed of NICE guidance and guideline development and implementation, must be overcome to ensure that future commissioning of treatments is more timely to ensure that England does not continue to fall behind other countries in Europe (and around the world) in terms of patient access to treatments.

EMIG supports the efforts on the part of the Department of Health, through the Office for Life Sciences, to widen access to innovative drugs and provide these medicines with an opportunity to develop mature data in preparation for a NICE Health Technology Appraisal. Innovative medicines offer potentially life-changing developments for patients, either through targeting a new or niche disease area, or transforming the way that patients receive their treatments. Innovation also holds the potential to deliver significant savings to the NHS and, of course, we support this laudable aim.

EMIG Proposal

It is essential that the move to consortia commissioning does not translate as 152 PCTs becoming 450-500 ‘PCTs'. The implications for the local access by patients to innovative drugs would be very damaging.

Value-based pricing

An important part of this debate is will be the development of principles for the introduction of value-based pricing in 2014.  There are a number of issues which need to be considered when addressing the question of ‘value' - most importantly which benchmarks will be used to determine ‘value' under the proposals for value-based pricing.  EMIG is in the process of developing detailed principles for submission to the Department's forthcoming consultation on this area.  We welcome this move as the first step in a much needed open discussion about the criteria for assessing ‘value' before any new scheme can be built.

EMIG believes that ‘value' should not be determined through blunt regulatory mechanisms. Value can be demonstrated in various ways outside of cost, such as through health and societal gains, as well as improvements that link to enhancing patient convenience and quality of life. When assessing value, societal, economic and productivity gains must be taken into account. Much of the development carried out by EMIG members is focused on the incremental innovation of existing products.  However, at present, innovation and the value derived from it is perceived to be the development and launch of new chemical entities (NCEs). The kinds of product improvements delivered by EMIG members, such as enhanced delivery mechanisms and medicines with fewer side effects, are of great benefit to the patient and the NHS, and yet they are not recognised under the current definition of innovative R&D in the PPRS.

Many products marketed by members of EMIG are based on existing molecules (off-patent brands) that offer product innovations which significantly alter the patient experience.  It is currently extremely difficult to get recognition for incremental product innovations as they are not NCEs, despite the amount of investment and R&D that might have been involved. To make value-based pricing more viable for smaller companies that are providing the NHS with low cost, high value products, it is essential that ‘value' includes incremental innovation.

EMIG Proposal

The Price of a Medicine

Innovation

Social Benefits of Medicines

The Cancer Drugs Fund (CDF)

EMIG Position

In addition to welcoming proposals to introduce value-based pricing, EMIG welcomes the aim of better access for patients to the best treatments and services for their conditions, specifically in the treatment of cancer. We know how difficult it can be for patients to get the right treatments in a timely manner particularly in cancer to ensure the best outcomes. We would like to know more about how the Fund will work and how experience from its implementation will be used to inform the development of value-based pricing.  We understand the CDF will assess each fund application on a case by case basis (in a similar manner to the Exceptional Funding Reviews) so we are concerned that this will not be an appropriate base model for value-based pricing.  

EMIG Proposal

 

4 - Accountability, autonomy and democratic legitimacy

EMIG Position

Transferring accountability for commissioning is appropriate. EMIG believes the three principal issues to be addressed by Government are:

EMIG Proposal

GP commissioning and the consortia

EMIG welcomes the decisions about health care commissioning to sit with the professionals who deliver the care in the primary care setting. Not only might this eventually reduce unnecessary referral to secondary care, but GPs, as the principal gatekeepers to the NHS, have an enhanced understanding of local requirements. It is essential, as stated previously, that 152 PCTs do not translate to 450-500 ‘PCT' consortia.

EMIG Proposal

We also have concerns around the size of the proposed consortia, the relationship GP consortia will have with secondary care providers and eventually all Foundation Trusts.  It is imperative that effective commissioning is driven by a thorough understanding of local clinical needs and that consortia have access to expert clinicians in with the support of experts in specialised areas of care, for example oncology, to ensure that commissioning effectively responds to patient needs.

The formation of an independent NHS Commissioning Board is a welcome development in this policy area and we look forward to understanding more about the functions of the Board and how it will be used to encourage the use of quality standards to ensure stronger commissioning and support local decision making. 

EMIG is also interested in the new role of Monitor as economic regulator for the health and social care sectors and would welcome clarity on the exact remit and the extent of its regulatory role, particularly in relation to price regulation.  Similarly we support the role of the Care Quality Commission as quality inspectorate, alongside HealthWatch in England and at a local level, and look forward to further detail in the forthcoming Health Bill. 

 

5 - Cutting bureaucracy, improving efficiency

EMIG Position

Through our work to support the implementation of the QIPP agenda we are supportive of the Government's objective to bridge the gap in healthcare funding.  However, we urge the Government not to lose sight of innovation as a principle in times of fiscal constraint.  We have considerable expertise in this area and would welcome the opportunity to support the NHS in developing the QIPP agenda. We believe a mind shift is necessary to move away from short term fixes to long term thinking favoured by industry.

We welcome the Government's review of Arm's-Length Bodies to cut cost and remove duplication and burdens on the NHS.  As noted above we would like to understand further proposals to expand the scope and remit of NICE in terms of its footing (be it statutory or advisory), how it will deliver quality standards as well as its new role to encompass social care standards.

We also welcome the Government's commitment to cutting the bureaucracy associated with medical research and await with interest the conclusions of the Academy for of Medical Sciences' (AMS) review before commenting further on these issues.

 

Conclusion

Whilst EMIG is supportive to the principles laid out in the White Paper and many of the reforms contained within it, we believe more detail is required on the proposed implementation of these proposals.  Of key concern to many, is the potential for disruption that much of this reform could cause the NHS in the immediate future and we therefore believe robust transition plans must be put in place to ensure that patient care does not suffer as a consequence of system reform. 

Clarity is also needed to ensure that the industry has sufficient time to respond effectively to the changing needs of the NHS and can ensure it is positioned as a partner to Government and healthcare providers in achieving the best and most efficient standards of care for patients and the best value to the NHS.  EMIG would like to work with the NHS and Department of Health to ensure that during this period of transition the standards of care, decision making and information are not compromised.

 

14.10.10 EMIG delighted by DH decision to ditch generic substitution plans

The Ethical Medicines Industry Group (EMIG) is delighted by the Department of Health's (DH) decision not to pursue proposals to introduce automatic generic substitution in primary care. EMIG members have fought against the introduction of automatic generic substitution believing it would have a detrimental impact on patients, prescribers, pharmacists and the pharmaceutical industry in the UK.

Leslie Galloway, Chairman of EMIG, said:

"The introduction of generic substitution has faced opposition from patients, professionals and industry. We are delighted the Department has listened to our concerns and abandoned its proposals to implement this costly and unwanted system. EMIG members opposed the introduction of generic substitution as they believed it could have hindered patient safety.

Moreover, EMIG believed that generic substitution would not result in significant savings to the NHS as approximately 83% of drugs are already written generically. Indeed, it may actually have increased the NHS medicines bill by eliminating any incentive for the continued development of medicines that offer greater patient choice as well as value for money to the NHS.  

EMIG welcomes today's decision and will continue to work with Ministers and officials to support the use of generic medicines in a way that is acceptable to patients, whilst also ensuring the UK remains one of the countries with the lowest drug prices in Europe."

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