It would be a matter of concern for theresearch based pharmaceutical industry,which has invested over €12 billion in theIrish economy and which providesemployment to over 20,000 people, shoulda system be introduced which would favourold products over new products and make itdifficult to develop a market for potentiallybetter products with enhanced efficacy,safety and/or quality profiles.

The Brennan Commission proposal torestrict the number of medicines reimbursedunder the GMS Scheme, would not be inthe best interests of patients. Theimplementation of this proposal wouldmean the abolition of the current single tiersystem of access to whatever medicine adoctor believes is appropriate for his/herpatient, regardless of the patient’s wealth.Such a system would deny poorer patientsaccess to the full range of modern medicines.

The decision on which medicines, if any, toprescribe should be one for a patient’sdoctor alone, and should not involve thirdparties.

At a time when the concern is to achievevalue for money questions must be askedabout the benefit of employing a wholebureaucracy to develop, maintain and keepupdated the lists necessary to operate areference pricing system. The referencepricing system in Norway had to beabandoned shortly after its introduction,because it ended up costing money ratherthan saving it.

The proposal that the Irish Medicines Board(IMB) assess the cost effectiveness of newmedicines, may have the affect of delayingthe admission of new authorised medicinesto the community drug schemes. Such asituation would see some patients havingtheir access to new treatments delayed andagain would introduce an inequity into theIrish system whereby patients with moneywould get access to all medicines whilstother patients would have to go without.

It is surprising that the Brennan Reportshould suggest that the (IMB) be given arole in the decision on whether a medicineshould be reimbursed. As far as IPHA isaware, there is no other country in Europewhere decisions on the authorisation andreimbursement of medicines are made bythe same agency – rightly, they take theview that these two processes should bekept separate as authorisation decisions arebased on a scientific assessment of quality,safety and efficacy whereas reimbursementdecisions involve broader public health andpolicy considerations such as whether aState can afford the product or whether it isfair to deny patients access to a medicine.

The consultative phase now commencingoffers an opportunity for constructivedebate. The ultimate objective of theintroduction of reforms should be to helprather than hinder the creation of a worldclass health service, where modernmedicines play a valuable role.

medicines mattermedicines matterThe I r i sh Pharmaceut ica l Healthcare Assoc iat ion S U M M E R 2 0 0 3

THE ROLE OF MEDICINES IN THE DELIVERY OF AWORLD-CLASS HEALTH SERVICEThe recently announced Health Reformpackage emphasises the need foraccountability, greater efficiency andimproved financial management. It is only right that the State should seek toensure value for the money it is investing inthe health services. However any analysis ofthe sums invested on new medicines mustbe balanced against the true value ofmedicines to our health services. Forexample less time spent in expensivehospital care, an improved quality of life withless time lost from work or education.

Alarm has been expressed at the growth inthe State’s expenditure on medicines but asimple analysis highlights the reasons forthat growth (see box).

• New treatments becoming availableand more patients availing of them,for example proton pump inhibitorsand new cardiovascular medication

• Ireland is starting from a low basewith poor life expectancy and one ofthe lowest utilisation of medicines inthe European Union. In the context ofa doubling of health expenditure andthe introduction of public healthinitiatives such the cancer strategyand the cardiovascular strategy it isonly to be expected that spending onmedicines will increase as thehealthcare system endeavours to

improve life expectancy and qualityof life.

• Increasing research anddevelopment costs, which now standat over €895m

• Epidemiological evolution – theincreased incidence of chronic andnon-communicable diseases such asasthma, diabetes and obesity whichare generally quite costly to treat.

• State decisions to enhanceeligibility and alter the administrationof certain community drug schemes.

WHY IS THE MEDICINE BILL GOING UP EVERY YEAR?An increasing population An aging population

An important milestone in the review of the EUpharmaceutical legislation occurred on 2ndJune, namely, the political agreement of theEU Health Ministers on the Commission’samended proposals for a new Regulation onthe European Medicines Evaluation Agency1

and amendments to the Codified Directive onhuman medicines2. The main points agreed at that meeting areas follows:• The scope of the Centralised Procedure is

to be widened. Thus, in addition tobiotechnology products, the CentralisedProcedure will also become mandatory forthe authorisation of medicines for thetreatment of cancer, AIDS,neurodegenerative diseases and diabetes.For medicines in other disease areas therewill be a choice between the Centralisedand Decentralised procedures. A reviewprocess will be introduced to add furtherdisease areas to the mandatory CentralisedProcedure diseases in due course.

• Regarding data protection, 10 years'regulatory data protection will apply to allmandatory Centralised Procedure products.For all other products (optional

VALUE OF MEDICINE BOX

REVIEW OF EU PHARMACEUTICALLEGISLATION

Centralised/Decentralised products), the periodof data protection will be 10 years, but with thepossibility for generic producers to apply for amarketing authorisation after 8 years. There willalso be an additional one year's data protectionfor significant new indications, but only formandatory Centralised Procedure products (seeabove). The Council’s decision not to providesimilar data protection for significant newindications in other disease areas is illogical, andprovides no support for further research in theseareas.

• The Commission’s proposal for a pilot project oninformation to patients in three disease areas(AIDS, asthma & diabetes) has been dropped.

Political agreement has not yet been reached on theVeterinary Directive aspect of the review packageand it is not yet fully clear when this will be achieved.Agreement on all three elements of the package(Regulation, Human Directive and VeterinaryDirective) will be necessary to reach a “CommonPosition” in the Council, and thus initiate the nextstep of the legislative procedure (second reading inthe European Parliament). All going well, thesecond reading in Parliament will

CLINICAL TRIALSDIRECTIVEThe Department of Health &Children is currently draftinglegislation to transpose (suggestthe word reverse here, easier tounderstand) the Clinical TrialsDirective 2001/20/EC in to Irishlaw. IPHA has recentlysubmitted a detailed paper tothe Department setting out theindustry’s views on how theDirective could best beimplemented.

One of IPHA’s stated objectivesis to enhance the environmentfor clinical research in Ireland sothat the State can continue toattract high quality internationalclinical trials. The issues to beaddressed in the implementationof the Directive from IPHA’sperspective, are: how best toformulate a single nationalopinion for multi-centre trials,how to enhance the functioningof ethics committees through thecountry and the need tostreamline the six-day ruleassociated with the giving ofconsent for clinical trials inIreland.

CHILDHOODVACCINATIONIPHA recently made asubmission to the Expert Groupestablished by the Minister forHealth and Children to examineand report on the process inplace to ensure the continuingquality of vaccine productslicensed for use in Ireland.

IPHA expressed concern at thedangerously low level ofvaccination uptake, particularlygiven the sharp increase in thenumber of cases of measlesbeing reported in the State. Thelatest figures from the NationalDisease Surveillance Centre(NDSC) show that there were303 measle cases reportedbetween November 2002 andFebruary 2003, a 500% increaseon the figure of just 50 cases forthe same period last year.

MIGRAINEThe Migraine Association of Ireland estimatethat approximately 70,000 work days are lost asa result of migraine and that the total cost tothe economy in terms of absenteeism and lostproductivity exceeds €33 million annually.This, for an illness which 96% of GP’s in a 1999IMS survey expressed the view that treatmentscan effect a significant improvement in patients’quality of life. Unfortunately, the same surveyfound 59% of migraine sufferers had neverconsulted their GP over the condition.

SCHIZOPHRENIA Schizophrenia costs the Irish economy morethan €150 million annually. 90% of this costrelates to hospital care costs and couldaccording to research, be reduced by an annual€70 million through the use of modernmedicines.

ASTHMA Appropriate medicines therapy as part of adisease management programme for asthmahas not only been shown to be cost effectivebut may also lead to significant improvementsin patients’ quality of life. An audit carried out

among 50 patients with severe asthmaattending a specialist asthma clinic in Leedsshowed that after six months, steroid costs hadrisen from €2,252 to €11,460. However, thecost of hospital admissions fell from €46,600 to€10,075, producing a net saving of €36,525.

The alternative to the use of modern medicineis not cost free; it may involve longer hospitalstays, longer less effective treatments, invalidity,sick pay and a poorer quality of life.

Diabetes is a good example of the benefits ofearly intervention. The care of diabetes coststhe Government approximately 10% of thetotal health budget. More than half of thismoney goes on the management of thecomplications of diabetes. There are estimatedto be 87,000 people diagnosed as havingdiabetes and a further 80,000 who havediabetes but do not know it. Targeting andearly diagnosis of this group would show thebiggest dividends in terms of benefit from earlyintervention and reducing later costs,associated with managing the complications ofdiabetes, to the State.

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1 Amended proposal for a Regulation of the European Parliament and of the Council laying down Community proceduresfor the authorisation and supervision of medicinal products for human and veterinary use and establishing a EuropeanAgency for the Evaluation of Medicinal Products2 Amended proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC on theCommunity code relating to medicinal products for human use

G10

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esIPHA HOLDSSEMINAR ONMEDICINESLEGISLATION IPHA recently held a specialseminar for member companieson Medicines Legislation inIreland. The seminar informedmembers of the pharmaceuticalindustry about the legislationregulating medicines in Irelandfrom various perspectivesincluding manufacturing,wholesaling, marketingauthorisations, labels andpackage leaflets, supply routesand controlled drugs legislation.

The Irish Medicines Board’sHead of Enforcement Mr HugoBonar outlined how the IMB’sEnforcement Unit operated andthe type of issues it wasconcerned about.

These included:• Samples - Ensuring that

company’s practices inrelation to the provision offree medical samples todoctors and dentists are inline with IPHA’s Code ofMarketing Practice and theAdvertising Regulations.

• Verifying the bona fides ofpersons who are suppliedwith medicines - Theimportance of havingprocedures in place to checkthe bona fides of allcustomers supplied withmedicinal products and inparticular, their entitlementto receive them.

On 28 April, senior executives of the research-based pharmaceutical industry took part in anew EU Round Table on Access to Medicinesconvened by Commissioners Lamy and Busquinto assess progress of the EU Plan for Actionand recommend practical action ahead of theG8 Summit in Evian (1-3 June).

Industry delegates reiterated their commitmentto work with all parties on measures which havea real capability to make a sustainable impacton access to better health in the developingworld. They emphasised the need to promotepublic-private partnerships as the best possiblemodel to improve access to vital qualityhealthcare.

Virtually all participants stressed the importanceof finding ways to increase the global funding

ACCESS TO MEDICINES IN POOR COUNTRIES

The G10 Report which was presented to theCommission in May this year was the result ofdiscussions on the issues surroundingpharmaceutical industry competition, innovationand the provision of medicines in Europe. Theprocess involved representatives of the industry,the Member States, the European Commissionand other interested parties, including patientgroups.

All over the world, Governments struggle tobalance the rights of patients to have the bestavailable treatments with the limited resourcesavailable to the EU’s health services. The G10Group reviewed the current arrangements inEurope and recommended changes with a viewto creating a situation where patients could havespeedy access to the best treatments, the Statecould achieve value for the money invested inhealthcare and the pharmaceutical industrycould have a climate in Europe in whichinnovation was encouraged and rewarded.

The G10 Recommendations cover a wide rangeof issues including; the benchmarking ofperformance, access to innovative medicines,the timing of reimbursement and pricingnegotiations, the generic market, the non-prescription market, incentives for research,enhanced information, patient informationleaflets, the funding of patient groups, relativeeffectiveness, pharmacoviligance.

A proposal which has attracted particularattention is Recommendation VI which statesthat:

“That the Commission and Member Statesshould secure the principle that a Member Stateauthority to regulate prices in the EU shouldextend only to those medicines purchased by, orreimbursed by, the State. Full competitionshould be allowed for medicines not reimbursed

by State systems or medicines sold into privatemarkets."

It embodies the concept that a MemberState’s authority to regulate pharmaceuticalprices should extend only to those medicinespurchased or reimbursed by the State. Theimplementation of this principle would offeropportunities for all “stakeholders”:

• It would enable European patients toaccess new medicines at the same time inall European countries without having toresort to cross-border purchasing.

• It would not impact on Member States’ability to negotiate or control the price ofreimbursed medicines and would have nobudgetary impact on their public finances.

• For Community authorities: it would favourthe Treaty goals of improved competitionand the establishment of the Single Market,which, for medicines, remain unfulfilleddespite progress in other aspects ofhealthcare policy.

• For Industry: it would allow for somemarket-based pricing flexibility and openup the prospect of enabling a viable privatemarket for some medicines which mightmeet industrial and social policy objectives.

In advance of the Irish Presidency of theEuropean Union in the first half of 2004 theTanaiste Mary Harney T.D. has been asked tobecome a member of the G10 implementationgroup. During the Italian Presidency of the EU inthe second half of 2003 the process will bemoved forward through the holding of aconference involving all the partners involved inthe G10 process. Progress to date will bereviewed and future actions agreed.

available to affected countries and tostrengthen local healthcare infrastructure, buildhospitals, provide clean water, train doctors,educate people, diagnose and prevent thespread of killer diseases, etc.

In late May the European Union agreed aregulation aimed at encouraging theprovision of essential medicines todeveloping countries at sharply reduced(“tiered”) prices. The research-based industrysupports the objectives behind the newRegulation - i.e. to tackle the diversion ofmedicines away from patients in poorcountries and, hence, to encourage morewidespread discounted pricing. However theindustry believes that the Regulation is toorigid in some aspects and may not fullyachieve its objectives.

NEWS FROM THE G10 PROCESS

from L-R: Mr Stewart Hutton, RocheConsumer Healthcare, Mr Hugo Bonar,Head of Enforcement, Irish MedicinesBoard, Ms Leonie Clarke, RegulatoryAffairs Manager, IPHA and Mr TonyMurphy, Roche Consumer Healthcare.

Irish PharmaceuticalHealthcare Association

Franklin House140 Pembroke RoadDublin 4IrelandT: +353 1 660 3350F: +353 1 668 6672E-mail: info@ipha.ieWebsite: www.ipha.ie

Content:Anne Nolan, Cathy Curran,Leonie Clarke and Brian Murphy

Publisher:© Irish PharmaceuticalHealthcare Association

Design and production:Slick Fish Design, Dublin

The Irish Pharmaceutical Healthcare Association (IPHA) raised over€51,000 for Ireland’s Special Olympics fund for 2003. Twenty one ofIPHA’s member companies donated generously to what was one ofIreland’s biggest and most prestigious sporting events to date.

The Special Olympics World Games took place from 20th-29th Junein various sporting facilities within the greater Dublin area. Eightymedical centres were established at various venues during theGames at an estimated cost of €500,000 for medical equipment,bandages, oxygen etc. The pharmaceutical industry was delightedto be able to help in funding these medical centres through themoney raised.

IPHA President Michael Dempsey said “It gives me greatpleasure to see that the Irish pharmaceutical industry supportedthis event in such a generous way. The Special Olympics WorldGames had the unique opportunity of combining the excitement ofsport with the opportunity for personal distinction and pride”

COMPANIES WHO CONTRIBUTED TO THE IPHA SPECIAL OLYMPICS FUND ARE:

Abbott Laboratories Limited Lundbeck Ireland LimitedA Menarini Pharmaceuticals Ireland Merck Sharp & Dohme LimitedAstraZeneca Pharmaceuticals Ireland Ltd Novartis Ireland LimitedBoehringer Ingelheim Ireland Limited Pharmacia Ireland LimitedBoots Healthcare Limited Roche Products (Ireland) LimitedBristol Myers Squibb Pharmaceuticals Sanofi-Synthelabo Ireland LimitedEli Lilly & Company (Ireland) Ltd Serono Pharmaceuticals LimitedFujisawa Pharma Servier Laboratories (I) LimitedJanssen-Cilag Health Limited Shire Pharmaceuticals Ireland LimitedJanssen Pharmacy Healthcare Solvay Healthcare Limited

PHARMACEUTICAL INDUSTRY RAISESFUNDS FOR THE SPECIAL OLYMPICS

IPHA sponsored the 3rd annual meeting of theIrish Platform of Patient Organisations, Science& Industry (IPPOSI) which took place in Dublinon Thursday 27th March.

IPPOSI is an off-shoot of the Medical ResearchCharities Group, which is an informal group ofthirteen charities involved in researchpromotion - Fighting Blindness, Alpha One,Irish Cancer Society, Children’s Medical andResearch Foundation, Irish Heart Foundation,Mater Foundation, Richmond Brain ResearchFoundation, Cystic Fibrosis Society, AsthmaSociety of Ireland, Arthritis Foundation,Meningitis Research Foundation, Debra Irelandand Diabetes Federation Ireland. Thesecharities have been working for the past twoyears with industry (Irish BioIndustryAssociation) and several individual scientists.The Platform is modelled on the EuropeanPlatform for Patients’ Organisations, Scienceand Industry (EPPOSI www.EPPOSI.org) which isa coalition between patients, science andindustry aimed at improving the legislative andregulatory procedures necessary to encouragethe early development of therapies throughoutEurope.

The theme of the 2003 IPPOSI Meeting was“Turning Research into Cures”, and it focusedon initiatives to create a world-class legislative,regulatory and practical environment toexpedite the development of therapies inIreland.

Over 50 people attended the meeting from theresearch charities, IPHA member companies,IMB, HRB, Enterprise Ireland, ScienceFoundation Ireland, Higher EducationAuthority, the universities and the IrishBioIndustry Association.

IPPOSI SEMINAR ON “TURNINGRESEARCH INTO CURES”

IPHA RAISES MONEYFOR HOMELESSCHARITY The Fifth Annual IPHA CharityGolf Classic was held at Glen ofthe Downs Golf Club on Friday27th June. The proceeds of thisyear’s event went to Threshold,an Irish charity which has beenworking for the last twenty fiveyears for justice on housing andhomelessness in Ireland.

The golfers took the opportunityto demonstrate their skills whileexperienced walkers took to theWicklow Way.

33 teams enjoyed very pleasantgolf in sunshine for most of theday. The outing concluded witha barbecue and prize giving atthe Glen of the Downs GolfClub which was thoroughlyenjoyed by participants as theyadmired the stunning views fromthe deck terrace.

IPHA NEWS

From L-R: Mr Philip Chambers, Mr ChrisFitzgerald, Department of Health &Children, Ms Aideen Hayden,Chairperson, Threshold, Ms AnneNolan, Chief Executive, IPHA, Mr TomMooney, Dept. of Health & Children andMr Patrick Burke, Director, Threshold.

Mr Michael Dempsey, President, IPHA, MsAnne Nolan, Chief Executive, IPHA and MsMary Davis, CEO, 2003 Special OlympicsWorld Games.

From left to right: Mr Michael Griffith, Fighting BlindnessIreland and IPPOSI, Dr Conor O'Carroll, Conference ofHeads of Irish Universities, Dr Ruth Barrington, ChiefExecutive, Health Research Board, and Ms LeonieClarke, Regulatory Affairs Manager, IPHA.