Select Committee on Health Written Evidence


APPENDIX 8

Memorandum by EMG European Medicines Group (PI 17)

1.  THE EUROPEAN MEDICINES GROUP

  1.1  The European Medicines Group (EMG) is the UK voice of research-driven pharmaceutical companies headquartered in Europe who develop and supply prescription medicines to the NHS. It has 21 member companies who employ around 12,500 people and invest approximately £250 million in medicines research and development in the UK each year. The purpose of EMG is to help patients, carers and policy makers understand the contribution of the European Pharmaceutical industry to the UK and to ensure that UK patients have the level of access to new, innovative medicines and to information about their medicines that is currently enjoyed by their European neighbours.

  1.2  The EMG is in agreement with the evidence submitted to this Inquiry by the Association of the British Pharmaceutical Industry (ABPI). It offers its own response based on:

    —  its ability to provide informed comment on how the UK compares with other European healthcare models that are based on a mixture of public and private provision and are more closely aligned with NHS values than many models from elsewhere in the world;

    —  the specific interest that EMG has in patient access to medicines and to medicines information that has arisen out of marked differences between the UK and neighbouring European countries with respect to those two important issues; and

    —  the intelligence it has accumulated, working with third party organisations and individuals over the past three to four years, on the attitudes and behaviours relating to these marked differences in practice between the UK and other European countries.

  1.3  The EMG is committed to working in partnership with the relevant stakeholders to promote an environment that improves access to effective modern medicines and that allows people seeking medicines information to source it from wherever they wish. In seeking to attain these improvements, EMG always works with total regard for the statutory and self-regulatory controls that provide an appropriate framework of checks and balances to ensure probity and good practice.

  1.4  This paper sets out how EMG approaches achieving its purpose and provides comment on the Terms of Reference of the Inquiry that are limited to patient aspects of drug information and education and to product evaluation.

2.  PROVISION OF DRUG INFORMATION AND PATIENT EDUCATION

  2.1  Like the Government, EMG believes that there is considerable potential to improve the health of UK citizens by giving them direct access to high quality health and medicines information. The focus of our activity is complementary to the various Government initiatives and strategies designed to improve health and medicines information and empower patients to take more responsibility for their own health.

  2.2  EMG does not advocate advertising prescription only medicines to the general public but does support people's right to request and receive medicines information from whichever source they choose, which includes amongst others, information from manufacturers. The ready availability of good quality information, appropriate to the patient's needs at the time, is the foundation for involvement in treatment decisions and supports ongoing self-management of chronic conditions.

  2.3  Although the volume of health and medicines information from a wide range of sources is increasing, much of this is not subjected to any regulation or standard and the quality is often questionable. This is likely to detract from, rather than improve health outcomes. The quality of information relies on interested parties agreeing and enforcing a set of standards and it is this aspect of information provision, as opposed to controlling the sources of information, that will best serve the demands of the public.

  2.4  The provision of information about medicines by the pharmaceutical industry is governed by local implementation and interpretation of European regulations for medicines labelling and advertising and by the industry's own Code of Practice. EMG has noted and welcomes the approach taken by the UK Medicines and Healthcare products Regulatory Agency (MHRA) which is more supportive of public access to information about medicines than the approach observed with some other European Regulatory bodies. It has developed helpful guidelines for providers of disease awareness programmes to the public and has supported the Medicines Partnership in the development of Medicine Guides accessible via the Internet. Although there is potential for considerable improvements in facilitating public access to medicines information, the UK is in fact amongst Europe's leaders on this issue. We would recommend that this Inquiry recognise this leadership role and encourages it to be sustained and further developed.

  2.5  EMG has been, and remains, concerned that changes to European legislation have the potential to infringe the public's right of access to information and may represent retrograde steps for the UK. In particular, the prohibition on advertising prescription medicines to the public must not be extended to, or interpreted as preventing, the provision of information to those people seeking it. The EMG has briefed a number of interested parties on this position including Health Ministers, UK and European Parliamentarians, civil servants at the Department of Health and representatives of health professional bodies and patient organisations. Support for this position has been strongly received from the parties consulted, and EMG would encourage further support from this Inquiry.

  2.6  Over the last four years, EMG has also held discussions with a number of stakeholders from all the above groups and, in particular those groups who represent the interests of patients either generally or for people with specific conditions. The purpose of this ongoing interaction has been to better understand the information needs of patients and the public, how these are currently served and what changes are needed to better meet the increasing demand for good quality information about health and medicines.

  2.7  A consistent view expressed in our interactions with patient organisations and other interested parties, is that the industry should be able to provide information to people seeking it provided that the appropriate quality standards are in place. It has also been repeatedly put to EMG that the industry is currently over-interpreting the regulatory framework and unnecessarily restricting its activities rather than responding to the public demand for information. A broader engagement between the manufacturers of medicines and the patients that rely on them is being actively sought by patient organisations, who point out that it is unrealistic to expect people to take medicines on a daily basis, often for the rest of their lives, whilst they are provided with much less information and support from the manufacturer than is currently available for most consumer goods.

  2.8  Over 30 patient groups attending a Patients Association meeting jointly sponsored by EMG and ABPI expressed the view that the currently available patient information on medicines was inadequate to meet the needs of patients and any limitations imposed on the sources of information would serve to exacerbate this situation. This is contrary to the opinion expressed from some quarters advocating controlling information by limiting the information providers. Patient groups consider this view to be both practically impossible and an unacceptable form of censorship.

  2.9  EMG recommends this Inquiry encourage interpretations of the existing regulatory framework that realise the benefits of better access to medicines information for people that seek it. A modern interpretation developed by a broad church of stakeholders, including patients, representation from the industry, the MHRA and other interested parties needs to ensure the information needs of today's patients are properly taken into account throughout the course of the conditions that they have to live with.

  2.10  Members of EMG wish to make available clear, accurate and relevant information in user-friendly formats both in response to direct personal requests and through access to a library of health and medicines resources available via company websites and other gateways available to those seeking information. It believes a modern interpretation of the current regulations would enable this to be achieved without the need for legislative change.

  2.11  In response to desires expressed by patient organisations with whom we have worked over recent years, EMG is planning to facilitate a workshop, inviting all the relevant stakeholders, the purpose of which will be to agree how to progress and improve health and medicines information for UK citizens in the future to better serve their requirements and assure against any retrograde steps emanating from future changes to European legislation.

3.  PRODUCT EVALUATION, INCLUDING ASSESSMENTS OF VALUE FOR MONEY

  3.1  EMG welcomes the various Government initiatives to improve the utilisation of medicines in the UK. NICE, the Scottish Medicines Consortium and latterly the All Wales Medicines Strategy Group have been set up as a means of assessing the clinical and cost effectiveness of new medicines across the UK and enabling patients to gain faster access to innovative treatments.

  3.2  In practice however, Government intentions have not yet been realised and the UK still has one of the slowest uptakes in Europe of innovative new medicines with health outcomes in areas such as coronary heart disease and cancer being poorer than in other comparable European countries.

  3.3  To examine the variation in medicines uptake between the UK and other European countries in more detail, EMG has interrogated the relevant data to produce a series of nine case studies for specific medicines.[19] Some, but not all, of these medicines have undergone review by NICE that, in the majority of cases, resulted in the Institute setting out the circumstances in which their use represented reasonable value for money to the NHS and recommending such use. The points below summarise some of the findings (full copies of the case studies are available on request):

    —  Uptake of cancer medicines launched in the five years from 1997-2001 ranges from 8.7-12.9% of the average of seven major markets in Europe; uptake of new medicines to tackle serious neurological conditions ranges from 17-23.5%.

    —  On average, other major European countries treat more than twice as many patients with Herceptin® per head of population compared with the UK, while Switzerland treats more than three times as many patients.

    —  Over four times as many patients in France and Belgium receive newer chemotherapy agents for colorectal cancer as in the UK, three times as many in Switzerland and Italy, 2.5 times as many in Germany and Finland, and twice as many in Norway.

    —  Patients with cancer-related anaemia in the UK are the least likely to be treated with recombinant human erythropoetin compared with other major countries in Europe, where usage is at least seven times higher than in the UK.

    —  Young people with cystic fibrosis have one of the lowest levels of treatment with Pulmozyme®, the only licensed treatment proven to improve the clinical parameters of the disease.

    —  Uptake of angiotensin-II receptor blockers, the latest generation of medicines to control high blood pressure, is at least half that of France, Spain, Germany, and Italy.

    —  France treats almost nine times more patients with standard therapy for Hepatitis C than the UK; on average, other EU countries treat more than six times more patients.

    —  The UK spends less than any other EU country on Photodynamic Therapy with Visudyne®, the only proven treatment for age-related macular degeneration, the most common cause of blindness in the over 50s. UK spend is one third of the average use per head of population in other EU countries.

  3.4  EMG has discussed these case studies with a wide variety of interested parties including Health Ministers, Parliamentarians, civil servants at the Department of Health and representatives of health professional bodies and patient organisations. In order to better understand why the uptake of new medicines in the UK is slower relative to comparable European countries, EMG has also facilitated discussions with local NHS organisations at a range of levels and is in the process of sharing its findings with the relevant stakeholders.

  3.5  The reasons for slow uptake identified in these discussions are varied and highlight that there is no solution that can be applied to all local NHS organisations. Three key areas that could impact on better utilisation of new medicines and local implementation of national policy and guidance emerged as:

    —  The impact of NICE evaluation of the value of medicines to the NHS and in particular, the need for a clear definition of what implementation of its guidance means in practice as well as clear accountability and responsibility for managing NICE guidance in local organisations.

    —  A need for dedicated and accessible funding specifically to support innovative interventions, with the proviso that such funding does not lead to budget distortions in other areas of healthcare.

    —  A need for processes for sharing good practice within an agreed set of criteria amongst local NHS organisations in order to overcome the variations in patient access to treatment that currently exist.

  3.6  EMG believes the pharmaceutical industry has a legitimate and valuable role to play, alongside NICE, the Department of Health and other organisations to promote consistency in access to innovative medicines between different parts of the country and comparable access to other European countries. Our interactions with other organisations suggest greater involvement from the industry in ensuring implementation of guidance and thereby improving access to medicines for patients would be welcomed and should be encouraged.

  3.7  EMG welcomes the recent appointment to the NICE Board of an Implementation Systems Director and is planning to facilitate a discussion group of interested stakeholders, including NICE and the DoH, with the purpose of considering how NICE implementation can be taken forward and better delivered at the local level, specifically, whether the role of a local NICE liaison officer might be a practical solution and if so, what that role might look like. We would encourage this Inquiry to support the need for clearly defined local accountability to improve implementation of national policy and guidance at the local level.







19   The case studies were developed between 2001-04 and do not include comparison with the countries joining the EU in 2004. Back


 
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