MEDICINES
matter
March 2009
IPHA President calls time on the suggestion that any further savings can be gleaned from industry Speaking at the Annual Meeting of the Irish Pharmaceutical Healthcare Association (IPHA), IPHA President Dr Gerald Farrell acknowledged that it has been the willingness of successive Irish Governments to take the long-term view and to work creatively with the pharmaceutical industry, which has delivered so much for Irish patients and the Irish economy over the past forty years. However, he added, the focus must remain on the achievement of long-term objectives and the State must not let immediate concerns, no matter how pressing, lead to the adoption of initiatives which seem attractive, but which could undermine our chances of achieving success in the long-term. He emphasised that the international research-based pharmaceutical industry can only source the large sums needed to
invest in research and development, if it can be reasonably certain, that where it achieves success, it will ultimately be rewarded for its endeavours. “It must be recognised that the medicines of today have to pay for the medicines of tomorrow and that if the State wants to capture the benefits of innovation they have to care for it and nurture it. Notwithstanding, we recognise that new therapies put pressure on State budgets, particularly in these strained financial times and we do understand the need for optimum efficiency and cost effectiveness in the State’s expenditure on medicines. That’s why, just over two years ago, the IPHA committed to an Agreement with the Health Service Executive which is well on the way to delivering savings in the order of €300 million” stated Dr Farrell.
A key feature of the IPHA/HSE Agreement has been a series of price cuts by IPHA member companies over a 24 month period, including a further round of cuts on the 1st January 2009. These concessions were onerous for the industry but they were offered on the basis that the Agreement would provide a stable framework for the following four years. At the time of committing to the Agreement it was made clear by the Government that it was “the first in a series of negotiations....to examine all aspects of the drug delivery system, from the manufacturer to the patient, in order to achieve greater value for money from the operation of the drugs schemes, consistent with patient safety and continuity of supply.’’ (Continued)
Mr Ross Hattaway (HSE), Dr Gerald Farrell (IPHA President), Mr Bryan Dobson (Moderator), Ms Anne Nolan (IPHA Chief Executive), Mr Pat O'Mahony (IMB) and Mr Seamus Feely (Irish Pharmacy Union) at the IPHA Annual Meeting.
IN THIS ISSUE
Global Health Progress Generic Substitution Revised Codes of Practice
Reduced Price of Medicines and more...
New treatments will open up greater possibilities for patients to recover from ill health (cover story continued) therefore a matter of disappointment and frustration to my members that State negotiations with the other elements of the supply chain have utterly failed to produce a single euro of additional savings. So any suggestion or expectation that there are further savings to be gleaned from my members or indeed any ambiguity on this point is unacceptable and will send a very negative signal to those in our corporate boardrooms who make decisions about continuing investments in Ireland” added Dr Farrell. Pharmaceutical innovation is on the verge of a new era of personalised and tailored medicine that holds great promise for patients and the healthcare system. That promise, however, is not a given and depends on sustained, substantial investment in R&D, a supportive public policy environment and an appropriate regulatory framework. New treatments will open up great possibilities for patients to recover from ill health, faster and more fully, turning for example, previously fatal illnesses into manageable chronic conditions. They also offer cost savings and improve efficiency, delivering financial benefits to the whole healthcare system, through optimal management and reduction of treatment times and hospitalisation. “Yes, we face challenges, but the encouragement of innovation in medicines, in how we deliver medicines and in how we deliver healthcare is central to the improvement of our healthcare system, of patient health and of our country’s economic development.” concluded Dr Farrell.
President, Dr Gerald Farrell speaking at the IPHA Annual Meeting.
Warning about purchasing medicines via the internet Speaking at the IPHA Annual Meeting recently, IMB Chief Executive, Mr Pat O’Mahony stated that it is important for healthcare professionals to highlight the dangers of purchasing medicines via the internet. According to figures presented by Mr O’Mahony there are approximately 2,500 illegally imported medicines seized and confiscated per annum. 90% of these are by individuals for personal use. While 50 to 60% of the imported medicines seized are counterfeit. He added that while the parallel trading of medicines is legal and legitimate it is one route through which counterfeit medicines could potentially come into the Republic of Ireland. The industry continuously encourages patients to purchase prescription medicines through authorised distribution channels only. The research based pharmaceutical industry spends billions of euro in developing reliable, safe life-saving and lifeenhancing medicines. The system that enables these medicines to reach patients, through the collaboration of regulators, pharmacists, healthcare professionals and the manufacturers of medicines, has protected Irish consumers very successfully.
Mr Pat O'Mahony, Chief Executive of the Irish Medicines Board.
Price of 700 medicines reduced again, by 15%, on 1st January Through the continued implementation of an agreement between the IPHA and the Health Service Executive (HSE) the price of many leading medicines has been reduced, in two phases, by 35% over the last 22 months. On the 1st March 2007 patients saw a reduction of up to 20% in the price of nearly 600 different packs of medicines on the Irish market. Amongst the packs
affected were many leading, long established, post patent medicines. The second phase of price reductions has resulted in the price of these medicines falling by a further 15%1. A further 45 medicines also began the process by reducing their prices by 20%2. It is planned that the price of these medicines will fall by a further 15% on the 1st November 2010.
The reductions form part of the innovative arrangements for the supply of medicines to the health services and benefit both patients and the State by providing savings on many leading, long established, post patent medicines to ensure that all patients, regardless of income, can continue to have access to the full range of innovative medicines in a timely manner. It has been estimated that savings of the order of €300 million across the GMS and community drugs schemes, and in the cost of medicines to hospitals will be achieved over the four years of the agreement which runs until 20103. Speaking at the time IPHA President Dr Gerald Farrell said: “These latest price reductions demonstrate the pharmaceutical industry’s commitment to Irish patients. We continue to hope that the substantial savings achieved through our action will allow for greater investment by the HSE into the most advanced, innovative, cost effective medicines, ultimately helping Irish people live longer, healthier, more active lives.” 1 2 3
HSE Corporate Pharmaceutical Unit HSE Corporate Pharmaceutical Unit Estimate from Department of Health and Children Press Release 6th July 2006
Comprehensive handbook on Ireland’s pharmaceutical industry available now IPHA has compiled the first edition of a Stakeholder Handbook with a view to providing assistance to interested parties with enquiries relating to the international research-based pharmaceutical industry in Ireland. The Handbook includes listings of key contacts within IPHA, IPHA member companies, Government, health and enterprise agencies, regulatory bodies, professional healthcare and enterprise organisations, voluntary healthcare organisations, patient organisations, international pharmaceutical associations and other global healthcare groups. In addition to key contacts within each of the listed organisations the Handbook also provides key facts and figures relating to the Irish pharmaceutical and healthcare sectors. If you would like to order a copy of the Stakeholder Handbook please contact communications@ipha.ie or (+353 1) 660 3350.
Generic substitution is not cost effective and may lead to a two-tier healthcare system into effect on the 1st September 2006 has significant implications for generic prescribing. The agreement will result in a two stepped 35% reduction in the wholesale price of off patent medicines resulting in savings which may exceed those anticipated with strategies such as generic substitution.” A recent article in the Irish Medical Journal on Drug Expenditure in Ireland 1997 – 20071 made the point that the 35% price reductions in the IPHA/HSE Agreement “obviates the need for strategies such as pharmacist lead generic substitution, which could have been difficult to implement in practice.” Industry fully appreciates the role which generic medicines play in the provision of comprehensive healthcare to today’s patients and accepts that making the full range of new medicines available to patients, poses significant challenges for the State’s finances. Therefore to create headroom in the budget for new medicines the IPHA agreed with the HSE to reduce the price of patent expired medicines in two stages by 35% in 2006. This price concession together with other aspects of the IPHA/HSE Agreement is expected to save the State nearly €300 million over its four year term. However, in recent months there have been calls for the implementation of generic substitution as a means to make significant savings on the State medicines bill. It is important to know the downsides of this proposal. A report published by the National Centre for Pharmacoeconomics in 2007 stated that: “The new agreement between the Irish Pharmaceutical Healthcare Association (IPHA) and the Health Services Executive (HSE) which came
Not only is substitution not cost effective and impractical it would be a regressive step in Irish healthcare. Currently we have a single tier system of access to medicines, whereby all patients, regardless of income have access to the medicines which their doctor believes is best suited to their needs. The introduction of generic substitution could lead to a two-tier healthcare system where those who could afford it would get the medicine of the doctors’ choice whereas poorer patients might not. It would also end the separation between the role of prescribing and that of dispensing, which has served health professionals and patients so well for many years. The Pharmacy Review Group itself concluded in 2003, “that there should be no beneficial ownership or business interest of any kind between dispensing and prescribing.” Therefore, generic substitution or any interference in the doctor’s right to choose the medicine, or indeed any other conflicts and contradictions in the medicines supply chain, should be vigorously opposed. 1
M Barry, D Molloy, C Usher, L Tilson, Irish Medical Journal, November/December 2008 Volume 101 Number 10
Did you know? • The last decade has seen an unprecedented increase in health expenditure following a period of cutbacks and stagnation in the 1980’s and the early 1990’s. Public expenditure on health will have almost quadrupled in the period 1998 to 2009. • State expenditure on medicines has increased in tandem with the increase in public expenditure on healthcare. Medicines account for just 14.7 % of total healthcare expenditure – a small but vital component. • Irish consumption of medicines remains amongst the lowest in Western Europe. Growth in the Irish market has to be viewed against this background and against the ever-increasing sums being invested to improve public health. • Today, approximately 25% of the Irish population have a chronic disease accounting for 78% of the country’s healthcare spending.
Industry view on primary medical care in the community but which also pose a strong financial challenge to the State. More than ever before the Government needs to focus on innovation to enhance outcomes rather than just measuring activity outputs over cost inputs, and health providers need to be focused on partnering, to achieve sustained improvements in patients’ health. Primary medical care should be characterised by its ease of access and sensitivity. To achieve this objective, everyone involved in healthcare should work together to identify how best to deliver healthcare to meet the needs of patients.
The Vista Primary Care Campus, which includes this pharmacy, is a good example of the services needed in Ireland.
In a recent submission on Primary Medical Care in the Community to the Oireachtas Committee on Health and Children the IPHA stated that “a properly structured system of care with patients able to access care at the lowest appropriate level is now more important than ever if proper use of scarce resources is to be made.”
Healthcare in Ireland is going through a period of significant change – an increasing and ageing population, evolving health structures, greater private sector involvement in the health arena, ever increasing public expectations of the service and the development of new treatments which offer hope to patients
The central ideas of seeking appropriate care at the appropriate level, encouraging patients to look after their own health through self-care and appropriate selfmedication and of prioritising early intervention are the fundamentals required for the development of primary medical care in the community. To learn about the Association’s concrete proposals for the implementation of these central ideas read the full submission at www.ipha.ie.
Revised Codes of Practice come into force IPHA is active in ensuring the highest possible standards of advertising and promotion of both prescription and nonprescription or consumer healthcare medicines to both healthcare professionals and the general public alike. It does so by administering a number of Codes of Practice, in particular, the Code of Marketing Practice for the Pharmaceutical Industry and the Code of Advertising Standards for Consumer Healthcare Industry.
The industry recognises the importance of patient organisations in representing, meeting the information needs of and offering support to people living with illhealth and the fact that pharmaceutical companies and patient groups have important areas of common interest. As a result IPHA has also incorporated in the Code guidelines for pharmaceutical companies on working with patient organisations in order to ensure that these relationships are positive, constructive, mutually beneficial and ethical. Areas covered include the provision of funding, information and the disclosure of such funding by pharmaceutical companies.
These Codes have been recently updated following the revision of the Medicinal Products (Control of Advertising) Regulations 2007 and the revised Code of Practice introduced across Europe by the European Federation of Pharmaceutical Industries and Associations (EFPIA). The key changes in the new Codes are: 1. The introduction of detailed provisions where the industry wishes to engage a healthcare professionals to carry out some consultancy services (Clause 17) or where the industry wishes to conduct a non-interventional study (Clause 19);
2. A ban on the use of “venues renowned for their entertainment or leisure facilities or [venues that] are extravagant” (Clause 16.3). This is to reinforce the point that it should always be the programme for meetings that attracts the delegates and / or not the associated venue and hospitality;
These changes are designed to bring greater openness and clarity to the activities of pharmaceutical companies. By so doing, the changes can help to ensure that the vital relationship between industry and healthcare professionals is maintained and the contribution of the industry to the lifelong education of healthcare professionals and enhanced patient and consumer care is better understood.
IPHA joins Global Health Progress IPHA recently joined Global Health Progress, an initiative sponsored by the global pharmaceutical industry to bring research-based pharmaceutical companies, global health leaders and policymakers together to build on current partnerships to improve health in the developing world. Dr Gerald Farrell, IPHA President stated that “the healthcare crisis in the developing world is of a truly frightening magnitude and everyone, including the pharmaceutical industry, has a responsibility to seek to enhance its contribution to tackling the crisis. Serving as a meeting point for the industry and its partners, Global Health Progress has already facilitated interaction between the private sector, NGOs and Governments in other countries to share research and best practices; raise awareness of global health challenges; and build partnerships to
improve global health. It is now hoped that, through our membership of this initiative, it will serve those in the Irish aid and development community.” Recently published figures, by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), show that since the inception of the UN Millennium Development Goals in 2000, the research-based pharmaceutical industry has made available enough health assistance to help 1.75 billion people in low and middle income countries. Donations of medicines, vaccines, diagnostics, equipment, other material and labour in the same period have been valued at $9.2 billion, of which $2.4 billion was in 2007 alone. The industry’s contribution is substantial and sustained and clearly reflects not only product contributions but also education and other actions for the long term. For more information on Global Health Progress please visit www.globalhealthprogress.com while for more information on the 150-plus health partnership programmes the industry is involved in around the world visit www.ifpma.org/healthpartnerships. Established in 1999, the Bristol-Myers Squibb SECURE THE FUTURE® programme has supported more than 200 projects focused on community education and outreach and medical care and research. It has also expanded its reach from 5 to 12 countries and evolved from a broad-based grant making initiative to focus on community based treatment support, paediatric AIDS and building NGO management and leadership capacity. To learn more about this and other programmes visit www.globalhealthprogress.org.
Medicines Matter is published by the Irish Pharmaceutical Healthcare Association (IPHA) which represents the international research-based pharmaceutical industry in Ireland. Its member companies include both manufacturers of prescription medicines and non-prescription or consumer health care medicines. Irish Pharmaceutical Healthcare Association Franklin House 140 Pembroke Road Dublin 4 Ireland Tel: (353 1) 660 3350 www.ipha.ie Fax: (353 1) 668 6672 www.medicines.ie E-mail: info@ipha.ie www.feelbetter.ie
Content: Anne Nolan, Brian Murphy, Ronan Collins, Michelle Kurtz, Sabine Louët Publisher: © Irish Pharmaceutical Healthcare Association Ltd Design and production: Slick Fish Design, Dublin