It has become more and more apparentthat the period ahead will be a challengingone for the State as it seeks to finance anever growing health budget, and for thepharmaceutical industry, as it seeks todevelop and make available newtreatments to patients.

The IPHA report, Healthcare Facts andFigures 2008, highlights how publicexpenditure on health quadrupled in theperiod 1998-2008 to reach an all time highof over €16 billion this year, accounting foralmost a quarter of all current Governmentexpenditure. Nonetheless publicexpenditure on health in Ireland, remainslow relative to our Western Europeanneighbors. Given our demographic andepidemiological trends, it will increase stillfurther in the years ahead.

The question is whether we can achievevalue for money from the ever increasingamounts invested in health. A growingand ageing population will havesignificant implications for public spendingand, in particular, health expenditure, asthe elderly typically require two to fivetimes as many resources as those under 65.

With one in five persons in Ireland obeseand every second person overweight, theincidence of chronic disease is set toincrease. This too will have a significantimpact on health expenditure. Irelandneeds to continue with its pro-innovationoutlook and commit to ensuringthat innovative solutions interms of treatments andservice delivery can facilitatethe development of theefficient and effectivehealth service we alldesire.

The ‘Personal HealthCheck Programme’,promised in theProgramme forGovernment, needsto be rolled out as amatter of priority.Comprehensive healthscreening would enable

health spending to be targeted in a waythat maximises the health benefits. This iscrucial to the sustainability of healthspending.

IPHA/HSE AGREEMENTThe appropriate use of medicines isparticularly vital in this respect. The Stateand the pharmaceutical industry through along-term partnership have ensured thatall patients, regardless of their means, haveaccess to the full range of moderntherapies. This relationship has supportedand encouraged innovation and has beenkey to the improvement of our healthcaresystem, patient health and our country’seconomic development. Ireland currentlyhas an efficient system which allowsauthorised products to be put on thereimbursement list in a timely manner,enabling prompt access for all patients tonew treatments.

Medicines prevent, treat and cure disease,improve quality-of-life, control pain andsuffering, reduce the need for costly,painful surgery, ease the burden on care-

IN THIS ISSUE

givers, delay or avoid costly long-termnursing care and save lives. And, in thecontext of limited healthcare resources,access to medicines can empower patientsto manage more of their own care withtimely, effective and convenient treatment.This allows the State to save millions inhealthcare costs which may be investedback into the health services.

The industry recognises and supports theState’s need to ensure that it gets value formoney for the large sums it is investing inthe health services, including on medicines.A mechanism to assess value for money iswelcome however industry believes that itshould be consistent with the State's pro-innovation outlook and not result inbureaucratic delays or, even worse,patients being denied access to newinnovative medicines. New treatments, infact, can help patients to recover morequickly, reducing hospitalisation costs,reducing time spent off work andlengthening life expectancy. It is vital thatany reforms that are undertaken in thehealth services should both fosterinnovation and speed its application in allareas where there will be benefits tohealth outcomes.

matterMEDICINES

May 2008

“MyPortal” New medicines development

Medicines in the community Getting serious about innovationand more...

Achieving sustainable health spending

Prof Kamal Sabra, Head of the HSE Corporate Pharmaceutical Unit, Mr John McLaughlin, IPHA President and MsAnne Nolan, IPHA Chief Executive at the IPHA Annual Meeting ‘Ensuring Innovation Delivers for Irish Patients’.

CLINICAL RESEARCH

There is a need to make innovation andthe innovation process work for patients.Ireland has a unique opportunity whichneeds to be grasped now, not tomorrow.

Healthcare providers in Irish hospitals andacademic institutions have shown that theyhave the ability to participate and driveworld-class research but they are limited bycurrent structures and practices. Theopportunity to take part in clinical trialsallows clinicians to develop a familiaritywith innovative therapies which can speedpatient access to such therapies once theyare licensed.

One of the biggest obstacles to theeffective, speedy commencement ofclinical trials in Ireland had been the issueof a standard indemnity. Last year, IPHAagreed a single standard indemnity formfor all pharmaceutical company led trialsconducted in the 56 HSE hospitals inIreland. Many private hospitals have nowalso introduced this standard indemnity,due to its benefits. However, thismomentum needs to be sustained. Theethics committee approval system needs tobe standardised and its predictabilityenhanced. We need to have fullcompliance with the existing legislationand we need protected time for researchclinicians and the development of a careerstructure for all clinicians, nurses and otherhealth professionals if we are serious aboutattracting a worthwhile programme ofclinical trials and world-class researchers toIreland.

Developing adequate capabilities forclinical research will help bring the fruit ofIrish-based research faster to patientsthrough translational research, in line withthe Government’s Science, Technology andInnovation Strategy. This is consistent withthe Government’s commitment to supportnew translational research centres such asthe newly created Trinity AcademicMedical Centre and the Dublin AcademicHealth Care Centre.

There is also a unique opportunity forIreland to position itself as a hub fortranslational research that would open thedoor of the country’s excellent researchcapabilities to research and developmentcollaborations with research-basedpharmaceutical companies. Indeed,

bringing early stage clinical trials to Irelandfrom discoveries made in R&D laboratorieswill help ensure prompt access for Irishpatients to innovative medicines once themedicine has been approved, thanks to thefamiliarisation of consultants at very earlystage of the testing of medicines.

Ultimately, innovative solutions, such asfocusing on the complications of illnessbefore they occur and treating themappropriately, are key to sustaining healthspending.

Achieving sustainable health spending (continued)

The development of new treatments and initiatives by theState to improve public health, coupled with an increasinglyageing population, means that expenditure on thecommunity medicines schemes has increased steadily inrecent years.

Specifically, the General Medical Services (GMS) Scheme whichprovides free medical services to persons who would not otherwisebe able, without undue hardship, to afford such services, rose overthree fold (308%) in the ten years 1998 to 2007. Changes in rulesrelating to medical card eligibility lead to substantial increases inthe earlier part of the period (2000/2003) with the average annualincrease being over 22%. In more recent times (2004/2007) theaverage annual increase has been nearly halved to just 11.5%.

The key factor behind the increase was the granting of medicalcards to everyone over 70 years old. Whilst less people overall havemedical cards than in 1994, the number of persons over 65 withsuch cards has increased by over one third in the same period. Theelderly typically utilise 2-5 times as many health resources as thoseunder 65, so not surprisingly as more of this age cohort receivedmedical cards the cost of the scheme increased dramatically.

Medicines in the community

Did you know?In 1995 AIDS was transformedfrom a death sentence into amanageable chronic disease andthanks to more than 20 anti-retroviral medicines discoveredand developed entirely by thepharmaceutical industry, deathrates from AIDS have plunged by80% in the US and Europe.

IPHA President, Mr John McLaughlin giving the welcome speech at the IPHA Annual Meeting“Ensuring Innovation Delivers for Irish Patients”.

There needs to be a greater realisationthat the advances of pharmaceuticalinnovation are continuous. Not allinnovative medicines are a result of“breakthroughs”. In fact, most medicineson the market today were created afterongoing, incremental steps were made toimprove products and treatments.Ongoing improvements provide patientswith medicines that are more effective,have fewer side effects, are easier to take,and are more tailored to a patient’sindividual needs. Ongoing pharmaceuticalinnovation not only produces newtherapeutic benefits for patients, but alsoleads us closer to “breakthrough”discoveries.

Pharmaceutical innovation is one valuablecomponent of health care. The diversityof medicines generated by innovationpermits greater choice and therapeuticprecision and plays an increasingly value-added role in health care delivery. Patientswho suffer from depression, for example,benefit significantly from the variety ofmedicine choices available to them. Forinstance, one new anti-depressant mayhave fewer side-effects for a particularpatient than a different but similar one.

Medicines are an integral and increasinglyimportant part of the Irish healthcaresystem. The benefits of ongoingpharmaceutical innovation are far-reaching. New medicines help control andprevent disease, but they can also cutdown on expensive surgeries and shortenhospital stays. The forward strides ofpharmaceutical innovation provide netbenefits to the health care system and theeconomy, and ultimately provide patientswith the best treatment options available.Overall, that means an improved qualityof life for people.

Not having access to innovative medicineshas obvious implications for the quality of care that patients receive.

Getting serious about innovationIf Ireland is serious about meeting its objective of increasing our level of innovation, focusneeds to be continued on creating an environment where investment is welcome, R&D isfostered, and innovative ideas are valued and protected.

Medicines are an integral and increasinglyimportant part of the Irish healthcare system. They prevent, treat and cure disease, improvequality-of-life, control pain and suffering and savelives. And, in the context of limited healthcareresources, access to medicines can empowerpatients to manage more of their own care withtimely, effective and convenient treatment.

The Strategy for Science, Technology and Innovation was welcome news for the Irish pharmaceutical sector.Money invested in pharmaceutical R&D directly benefits patients – who receive the latest treatments – and itsupports the Irish scientific community who are critical in moving Ireland further up the international value chain.In order for the State to ensure maximum return on its investment it is important that the Irish tradingenvironment remains favourable to industry – not just with regard to R&D. For the pharmaceutical industry toremain strong all key environmental factors – from promoting a strongly collaborative relationship with the HSEto promoting new innovative technical capabilities – must be actively pursued so that pharmaceutical companiesin Ireland meet their potential.

New medicines developmentoffers hope that there will befuture breakthroughs

0 100 200 300 400 500Number of Medicines

600 700 800 900

Source: PhRMA, Innovation.orgNote: 2007 data for Children, HIV/Aids, Infectious Diseases, Rare Diseases, Women, 2006 data for Biotech, Mental Health, Neurological Disorders, Ageing, Cancer

92

197

219

241

277

303

338

418

646

700

Ageing

Women

Cancer

Biotech

InfectiousDiseases

Rare Diseases

Heart Diseaseand Stroke

NeurologicalConditions

Children

Mental Health

HIV/AIDS

900

According to the IPHA report, Healthcare Facts and Figures 2008, theresearch-based pharmaceutical industry is one of the principalcontributors to the growth of the Irish economy. It employs 24,500people directly with as many people employed in providing services tothe industry. In 2006, pharmaceutical exports exceeded €14.8billion maintaining Ireland’s position as the largest net exporter ofpharmaceuticals in the world. While using the broader pharmachemmeasure, exports exceeded €36 billion, or nearly 50% of all exportsfrom the State.

However, with a downturn in the pharmaceutical industry globally dueto growing generic competition, stricter regulatory requirements and anunwillingness by some Governments to fund and support innovation,Ireland needs to continue with its commitment to supporting andfostering innovation which is central to the further developmentof the Irish economy.

Good news for Pharma Ireland, but continued support required

Many changes are taking place in the way wediscover new treatments and cures for disease.Cancer, diabetes, heart disease, and otherdeadly conditions affect millions. Newmedicines have led to improved treatments ofcertain forms of breast cancer, hypertension,and AIDS, while other medicines have slowedthe decline of degenerative conditions such asAlzheimer’s disease or arthritis.

As impressive as advances in pharmaceuticalshave been, the work is far from over. Millionsof people with serious diseases and conditions,and a health care system struggling with risingcosts and gaps in quality, can benefit from newmedicine discoveries.

There are currently over 600 medicines indevelopment to combat cancer. These include96 for lung cancer; 79 for breast cancer; 66 forcolorectal cancer and 79 for prostate cancer.Additional medicines target brain, kidney,ovarian, pancreatic, skin and other cancers.

Researchers right across the pharmaceuticalindustry are working on 277 medicines for twoof the leading causes of death in Ireland –heart disease and stroke – keeping up themomentum of drug discovery that has helpedcut deaths from these diseases by more than40% in the past 15 years.

Twenty-five years ago, the treatment for heartattacks was simply bed rest. Today, doctorshave medicines that can stop a heart attack inmid-stream as well as other high-techtreatments.

Many of these potential new medicines willfail in clinical trials. But some may representtomorrow's breakthroughs to cure or preventdisease, reduce disability and improve qualityof life for patients.

Did you know?In 1975, surgery was used to treatpeptic ulcers. With the discoveryof a new class of medicine – H2antagonist blockers – and thelaunch of a further new class ofmedicines – proton pumpinhibitors – in the late 1980’s, themanagement of peptic ulcerdiseases has been revolutionised.As such the need for surgicaloperations have steadily declinedand have almost beeneliminated.

Researchphase

10,000 molecules screened

From concept to product:steps in the genesis of a medicine

100 molecules tested

10 candidate molecules1 medicine

Testphase

5 years0 15 years 20 years

Patent filing Patent expiry

10 years R&D 2 to 3 years

Developmentphase

AdministrativeProcedures Commercialisation phase

10 years

The complexity of diseases researchedtoday, together with the ever-increasingsafety concerns make it difficult to succeedin R&D. In fact, the probability of success isless than one percent. Despite the largestever (and growing) number of compoundsin R&D pipelines, the number of newinnovative medicines reaching patients hasnot increased significantly.

The discovery, development, testing andgaining of regulatory approval for newmedicines has become an even morehighly complex, lengthy, risky andexpensive process with each success builton many, many prior failures. As anexample, termination of late stage humantesting (Phase III) of pipeline compoundswent from 30 to 50% in the 1990’s.

To turn out just one to two productsrequires about a hundred discoveryprojects or approaches, involving upwardsof 7 million compound tests in earlyscreening assays. This level of screeningproduces about a thousand compoundswith some of the criteria researchers arelooking for. Follow-up molecular designand sophisticated biological testingnarrows the number of developmentcandidates. Once safety is confirmed inanimal studies, compounds are advancedinto human clinical trials where efficacy,safety and toleration are confirmed. Assuch the cost of developing a medicine hasgone from €149 million in 1975 to€1,059 million in 2007.

It takes an average 10 to 12 years todevelop a new medicine from the time it isdiscovered to when it passes the regulatorystandards of safety, quality and efficacyand is available to patients. Once on themarket the average medicine has only 8 to10 years of effective patent protection leftbefore facing generic competition.Moreover around 70% of medicines thateventually reach the market do not provide

sufficient return to recoup their R&Dexpenditure before they lose patentprotection. As a consequence, the returnon investment is highly dependent on alimited number of successful products.

The fact is that committing resources intoresearching new medicines is really an actof faith, which requires massiveexpenditure with no guarantee of return.

IPHA welcomes two new Board membersMs Elizabeth Reynolds B.Comm. (Hons) M.B.S. and Mr David Gallagher B.Agr.Sc.M.B.S. recently joined the IPHA Board of Directors and the IPHA Prescription MedicinesDivision Strategy Board respectively.

Ms Elizabeth Reynolds attended University College Dublin where she graduated with anHonours Degree in Commerce and a Masters Degree in Business Studies (Marketing).She is currently Vice President and General Manager of GSK Consumer HealthcareIreland.

Elizabeth has significant experience within the Consumer Healthcare Industry havingworked in various positions both in the UK and Ireland. She is a Council Member of theBeverage Council of Ireland as well as an Executive Board member of the Nutrition andHealth Foundation.

A graduate of University College Dublin with a Bachelor of Science Degree and theMichael Smurfit Business School Ireland/KU Leuven, Belgium with a Masters Degree inBusiness Studies, Mr David Gallagher is currently Managing Director of PfizerHealthcare Ireland, a position he was appointed to in May 2007.

David has significant international experience in the pharmaceutical and biotechnologysectors having worked in various positions within the industry globally.

The increasing complexity ofmedicines development

“MyPortal” gives patients and doctors ameans to keep informed about clinical trialsThe International Federation ofPharmaceutical Manufacturers &Associations (IFPMA) Clinical Trials Portal(CTP) which provides an easy-to-use,single point of access to a comprehensivearray of online information aboutongoing clinical trials sponsored by theinternational research-basedpharmaceutical industry, and summaryresults of completed trials has beenfurther improved with the introduction of“MyPortal”.

“MyPortal” allows users to record searchcriteria, to simply repeat searches and torequest e-mail alerts when new trials areposted that match criteria they havespecified. To make information found bythe Portal more readily understandable,explanations in everyday language aremade available for technical expressions,via convenient mouse-over-activated textballoons. The entire portal interface hasalso been redesigned for greater clarityand the display of search results has beenrefined, to help users find trials of interestmore quickly.

Industry is acutely aware that patients,especially those with serious long-termconditions, have an interest in keepingthemselves informed about trials of newcandidate medicines, as do the doctorstreating them. “MyPortal” will make iteasier for them to do so. Theimprovements also confirm industry’sdetermination to translate clinical trialstransparency into a more accessible,practical self-help health tool for patientsand doctors.

You may visit the Clinical Trial Portal atwww.ifpma.org/clinicaltrials.

Irish Pharmaceutical Healthcare Association

Content:Anne Nolan, Brian Murphy, Ronan Collins, Michelle Kurtz, Rebecca CrampPublisher: © Irish Pharmaceutical Healthcare Association LtdDesign and production: Slick Fish Design, Dublin

Franklin House140 Pembroke RoadDublin 4Ireland Tel: (353 1) 660 3350 Fax: (353 1) 668 6672 E-mail: info@ipha.ie

www.ipha.iewww.medicines.iewww.feelbetter.ie

Did you know?New innovative medicines haveresulted in 8 out of every 10children with leukaemiasurviving.

Death rates for all childhoodcancers have dropped by over50%.

The five-year survival rate forwomen with breast cancer hasincreased by 80%.

Medicines Matter is published by the Irish Pharmaceutical Healthcare Association (IPHA) which representsthe international research-based pharmaceutical industry in Ireland. Its member companies include bothmanufacturers of prescription medicines and non-prescription or consumer health care medicines.