medicines mattermedicines matterThe Ir ish Pharmaceutical Healthcare Association M A R C H 2 0 0 7

NEW IPHA PRESIDENTMr John McLaughlin was recently electedas President of the Irish PharmaceuticalHealthcare Association (IPHA).

John has over 20 years’ experience in theEuropean pharmaceutical industry havingheld positions in the UK and Sweden.John is also Managing Director of sanofi-aventis in Ireland – he became MDfollowing the merger of Sanofi-Synthelaboand Aventis Pharma in December 2004.He has been an active member of theIPHA Strategy Board since theAssociation’s inception in 1996.

Upon taking office John said that animportant goal of his Presidency will be toestablish even deeper relationships withIrish healthcare partners and StateAgencies.

In a recent address at the IPHA AnnualDinner he noted that as an industry we aremoving from the old model of “developand sell” to a model based on “innovationand engagement”. Increasinglypharmaceutical companies are becomingmore collaborative, more transparent andmore sensitive to customer needs,delivering more complete healthcaresolutions. As an example, IPHA members,with the support of IDA Ireland and

HIGH QUALITY INFORMATION WILLBENEFIT IRISH PATIENTS

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Valu

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Partnership

Within the High Level PharmaceuticalForum it was decided to developinformation on diabetes as an example ofthe type of information which maybeprovided to patients. In Ireland alone, it isestimated that there are 200,000 peoplewith diabetes and a further 200,000 whohave diabetes but are unaware that theyhave the condition. According to DiabetesIreland “It is generally accepted that thereis a distinct lack of awareness in thecommunity about diabetes and itssymptoms.” Information is the key tohelping these people live longer, healthierand more productive lives.

Patients have a legitimate need for, andright to, information about diseases,therapeutic strategies and medicinalproducts. There is widespread agreementamong EU institutions and the public thatcommunications with patients and thepublic about prescription medicinesshould be improved with the objective ofhaving better informed patients, so theycan make sensible choices about theirtreatment.

Patients are being provided withincreasing amounts of information fromdifferent parties with various objectivesand sent through multiple channels,particularly on the internet. Thisinformation is of varying quality andaccuracy. Ironically the manufacturers ofmedicines are largely restricted fromproviding information to patients whilstanyone else it seems is free to do so.Would it not be better for patients to getgood quality information, in a well-regulated way, from the actual source oftheir treatments? As noted recently byEuropean Commission Vice PresidentGunter Verheugen the current restrictiveposition in many Member States and EUcitizens’ uneven access to information, are”unsatisfactory and (…) evenunacceptable.”

Industry has a key role to playThe pharmaceutical industry firmlybelieves that better informed patients willlead to safer and more successful health

outcomes, a more efficient use ofhealthcare resources and ultimately, tohealthier societies.

It is clear that no single source can provideall the available information butpharmaceutical companies have a wealthof knowledge and information to shareabout health and medicines havingresearched and developed their productsover a long period (average 10-12 yearsper approved product). Thepharmaceutical industry is not advocatingUS style Direct-to-Consumer-Advertisingas an appropriate model for Europe; ratherit believes that it should be enabled, alongwith a range of other sources, to supplynon-promotional, high quality disease andhealth related information to EU citizens.

Taking the initiative in IrelandThere are examples of excellenteducational activities produced orsupported by pharmaceutical companiesin Ireland. The obvious example is diseaseawareness activities (see related article),which broadly encourage patients to seekmedical help for conditions, which theythought were untreatable, are subject tostigma or taboo (such as sexuallytransmissible diseases) or simply too“embarrassing” (e.g. incontinence). Pharmaceutical companies also producematerials solely for distribution after theirmedicine has been prescribed. These helppatients to use their medicines correctly ina variety of ways; for example, by

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IPHA President Mr John McLaughlin

In recent years, a number of pharmaceutical companies havebeen associated with public advertising campaigns designedto raise awareness of specific diseases and encouragesufferers or at risk people, to seek advice on treatment.These campaigns can be of great benefit to the public,informing them of facts about their condition andhighlighting appropriate sources of advice.

Many of the campaigns have been run under the umbrella ofpatient associations and have been funded wholly or in partby the industry. The campaigns are particularly useful forconditions or symptoms that might otherwise go untreated,

including asymptomatic diseases like diabetes andhypertension, and embarrassing conditions like impotenceand incontinence. When it comes to serious, life-threateningand quality-of-life-threatening diseases, such as diabetes,lack of patient knowledge can lead to problems.

Appropriately planned and structured disease awarenesscampaigns run in conjunction with credible patientassociations can grow a patient population, not by drawing inpeople who don't need treatment, but by educating thosewho do, to recognise the fact.

Naturally, this can lead to increased demand on the healthservices but surely that's better than letting these patientswait until their condition becomes much more serious,perhaps requiring expensive hospital treatment? And that'sjust the economic viewpoint. What about the harm done tothe quality of life of those who live in ignorance of thetreatments available for their condition - or even of thecondition itself?

The pharmaceutical industry in this country is committed tobehaving in a responsible, ethical and professional manner.All of the activities of the industry including disease

awareness campaigns are subject to stringent pharmaceuticalregulations and rigorous Codes of Practice (see www.ipha.ie).Industry is committed to improving information andcooperating with all involved parties, such as doctors,regulators and pharmacists, to ensure the appropriate use ofmedicines. Disease awareness campaigns motivate people toseek help and advice from healthcare professionals forsymptoms they have simply been tolerating, for seriousconditions they didn't know they had, or for conditions theythought untreatable.

For further information contact Mr Ronan Collins(ronancollins@ipha.ie).

DISEASE AWARENESS CAMPAIGNSResponsibility

explaining simply what the condition is,what the medicine does and theimportance of using it properly, byproviding advice and aids on self-administration techniques where, e.g.eye drops or inhalers, are involved, byproviding memory aids for dose timingand by providing self-help advice andsupport.

The IPHA Medicines Compendium CDprovides independent, regulatoryauthority approved information on over2,000 medicines currently on the market.The latest CD was provided free ofcharge to all GPs, Consultants,community and hospital pharmacists inthe country. It allows the user to learnmore about the correct use of medicines– such as what the possible side effectsof any medication might be and how aparticular medicine might interact withanother. It is an accompaniment to theIPHA hosted website www.medicines.iewhich provides up to the minuteinformation on prescription and ‘over-the-counter’ (non prescription)

medicines. These materials supporthealth professionals’ work and help toensure the safe and effective use ofmedicines.

Informed patients arehealthier patientsThe High Level Pharmaceutical Forum,which brings together Ministers from EUMember States, representatives of theEuropean Parliament, patients, thepharmaceutical industry, health careprofessionals, and insurance funds, wasestablished in June 2005 to examine thecompetitiveness of the European-basedpharmaceutical industry and relatedpublic health issues. One of the issues itis examining is that of information topatients. It is charged with advising onways to improve the quality ofinformation on authorised medicinesavailable to European patients. In a recent progress report, the Forumwelcomed the proposal for developingguidance on the production of highquality, easily understandable and

accessible information on diseases andmedicines (including prevention whereappropriate) for people in Europe.

It further stated that informationcreation and exchange based onpartnerships should be definedaccording to different situations (e.g.differences between national healthsystems) – possible partners it identifiedincluded Member States,patient/consumer organisations,physicians, pharmacists, other healthcare professionals, industry, socialinsurers and the wider stakeholdercommunity including learned societiesand academia. This was echoed byCommissioner Verheugen. He statedthat “a potential source of informationis the industry which has theknowledge, skills and resources toprovide, at least, basic information.National and European regulatoryauthorities already depend on theindustry to provide information forleaflets, labels and national databases.There is no reason why we should notbuild on this.”

HIGH QUALITY INFORMATION WILL BENEFIT IRISH PATIENTS (CONTINUED)

QUALITY HEALTH INFORMATION, A WIN-WIN FOR ALL

Dr Leonora Bishop, Head of Life Sciences withinthe Research, Skills & Manufacturing Division ofIDA Ireland spoke about the IDA’s work in

creating andimplementing strategicinitiatives thatencouragemultinationalcompanies to carry-outR&D activities inIreland. Havingattracted leadingpharmaceuticalcompanies to thisisland Ireland is alreadyidentified as a key

location for the global pharmaceutical industry.

“In order for Ireland to be successful goingforward we must assist more companies gain acorporate R&D mandate as well as, develop IrishR&D value propositions that attract corporateR&D decision makers.” stated Dr Bishop. According to Dr Bishop these include:

• Having the people with the right researchexpertise;

• Having the right science and technologyplatforms;

• Sharing a substantial proportion of the risk;• Providing simple and reasonable access to

intellectual property;• Having the right fiscal environment to

incentivise spend and subsequentexploitation.

Dr Bishop explained the approach taken by IDAIreland. She stated that “marketing and brandingIreland internationally as a knowledge, innovationand technology business location; creating amajor operational focus on developing R&Dcapability in-company as well as developing‘connectedness’ between Industry and Academiathrough collaborative R&D are all key elements ofthe IDA strategy to encourage multinationalcompanies to carry-out R&D activities in Ireland.”

For further information contact Ronan Collins(ronancollins@ipha.ie).

“Innovation is the central issue in economicprosperity” according to Michael Porter. His wordsare quite appropriate for Pharma Ireland today.

At the recent IPHA Annual Meeting industryprofessionals heard that the pharmaceuticalindustry in Ireland will have to move up the valuechain if Ireland is to remain a key location for thepharmaceutical industry into the future. The valuechain, a systematic approach to examining thedevelopment of competitive advantage was aterm created by Porter in his book, CompetitiveAdvantage (1985) where by activities such as R&Dcreated and build value.

These theories were echoed by the Minister forEnterprise Trade and Employment Michael Martinwhen he said that the country needed to attract anew type of high end manufacturingconcentrating on research and development,process development and drug discovery. He saidthat the Government was working to refine thecurrent R&D tax credit so that it could better helpto assist in making Ireland a centre renowned forits research excellence.

IPHA President John McLaughlin said that overthe last 20 years Ireland had become a location ofchoice for the international research basedpharmaceutical industry. Fourteen of the topfifteen pharmaceutical companies worldwide nowhad manufacturing operations in Ireland and thecountry is the largest net exporter ofpharmaceuticals in the world. He said that thatthere were many competing centres around theglobe for pharmaceutical investment and thechallenge was to move up the value chain in theyears ahead. A vibrant, research-ledpharmaceutical industry was needed to helpcreate the knowledge-based economy Irelandneeds to be successful in the 21st Century.

Professor Des Fitzgerald, Chairman of the HealthResearch Board, identified clinical research as ‘areal opportunity for Ireland’. He pointed out thatthe quality of clinical care and research, the scaleof the population, the level of investment inacademic research and the commitment ofgovernment to invest in the knowledge economyhad all created this opportunity. To turn thisopportunity into reality further investment wasrequired to ensure more clinicians could engagein clinical research.

IPHA President John McLaughlin identified threethings that needed to be done if Ireland was tobecome a world centre for clinical research:

“We need to standardise the ethics committeeapproval system and enhance its predictability.We need to have full compliance with the existinglegislation and we need sufficient funding toenable the employment of dedicated healthresearchers throughout the health services.”

He said that unless the current problems wereironed out, Irish patients and researchers wouldcontinue to miss out on the benefits of earlyaccess to important new treatments.

For further information contact Mr Ronan Collins(ronancollins@ipha.ie).

IMPACT OF NURSEPRESCRIBING

Value

BUILDING R&D IN LIFE SCIENCES

CLINICAL RESEARCH: REALVALUE FOR IRELAND

Innovation

The impact of nurse prescribing onthe NHS in the UK was summedup in just a few words at the recentIPHA Annual Meeting. Ms TrudyGranby, Assistant Director of theNHS National Prescribing Centresaid that “the extension ofprescribing responsibilities tonurses was fundamental tomodernising the NHS”. MsGranby has been involved in theimplementation of nurseprescribing, at both local andnational level, since the early pilotsites were established in the UK in1996.

She identified research carried outby the National Prescribing Centreon the key areas where nurseprescribing has had an impactwithin the health services in theUK. It showed that:

• Patients’ access to medicineshad increased;

• Patient waiting time had beenreduced;

• Existing services had beenimproved;

• New services had beendeveloped;

• Doctor time had been freedup;

• Nurse time had been saved;• There was increased job

satisfaction within theprofession.

IPHA recently submittedcomments to the Department ofHealth and Children on this topicwelcoming proposals that widenaccess to modern and effectivemedicines in accordance withgood clinical care to the benefit ofpatients.

For further information contact DrRebecca Cramp(rebeccacramp@ipha.ie).

IPHA ANNUAL MEETING

Innovation

Ms Anne Nolan, IPHAChief Executive with

Minister for Enterprise,Trade and Employment,

Mr Micheal Martin TDand Mr John McLaughlin,

IPHA President at theopening of the IPHA

Annual Meetings.

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, Brian Murphy,Ronan Collins, Rebecca Cramp

Publisher:© Irish PharmaceuticalHealthcare Association Ltd

Design and production:Slick Fish Design, Dublin

SOMEONE HAS TO PAYFOR INNOVATIONThe cost of healthcare is rising in nearly allcountries of the European Union (EU). Sincethere are hardly any options to increase revenue– except by raising taxes or introducing highercharges, those responsible are searchingdesperately for ways to save costs. Items suchas medical doctors’ salaries or hospital budgetsare considered taboo, and so the expenditurefor medications is usually the main focus – to anextent that far exceeds this segment’sproportion of total costs.

The paradox is that EU experts are fully awareof the importance of a competitive andinnovative pharmaceutical industry. But, incomparison with the U.S., for instance, thepharmaceutical sector in the EU has recentlylost ground. There are many reasons for this,such as less networking between academic andindustrial research, the highly fragmentedEuropean market, a lack of risk capital and theunpredictable development of health policy.However, focusing on drug costs frequently failsto achieve the desired effect – especially inpricing policy.

Medicines are often considered isolated fromthe total picture. Instead of silo budgeting, thecommonly used form today,a look at the overalleconomic situation wouldbe far more informative. Forexample, medicines cansometimes help shortenstays in hospital. But onething should be perfectlyclear to everyone: lowerearnings will also reduce the financialpossibilities of pharmaceutical manufacturers todevelop new innovations. Above all they musthave the prospect that investment in innovativeproducts will some day pay off in the market.Without this certainty an important incentive islacking. Some people even propagate theerroneous idea that true innovation in thehealthcare sector only comes from smallbiotech companies and not the majorpharmaceutical manufacturers. Indeed, thetruth is that both depend on each other. Most

Science Foundation Ireland, aredeveloping partnerships with Irishthird level institutions. Thesepartnerships offer great hope ofimproved treatments not only forIrish patients but for patientsaround the globe and they willconsolidate our image andreputation as an increasingplayer, of world class standard, inthe area of pharmaceuticalresearch and innovation.

He will also focus on developingIPHA’s role as an important playerin Irish healthcare. IPHA willremain keenly focused ondeveloping partnerships thatbuild healthier societies duringthe course of his Presidency.

John will hold the position ofIPHA President for a term of twoyears.

biotech companies simply do not have thecapacity to turn their ideas into marketableproducts. Because of this mutualinterdependence it damages the entire branchif one partner, i.e. the large companies, isweakened by certain regulations. And thisoccurs through pricing policy.

Generics cause further problems. In some EUcountries the amount of the reimbursement fordrugs is reduced to the price level of genericsafter patent protection ends. And this pricerestriction often extends to include “similar”medications that are still under patentprotection. This policy is not only an attack onthe rights to intellectual property, it alsofrustrates the incentive to develop moreinnovative drugs.

Many European governments act as if druginnovation is a matter of course and completelyindependent from their own policies. Sinceinnovative medications are available todaybeyond borders, more and more people forgetthat innovation can only continue if somewheresomeone pays for it. Governments that reducetheir national drug prices lower theircontribution to accrued costs and hope that

others will take care ofit. If everybody actedthis way, theconsequences wouldbe clear. The strategyof the individualcountry ends upcontradictory to thecommon goal. One is

reminded of the prisoner’s dilemma in gametheory. It assumes that the player who actsselfishly, but trusts in the cooperation of hispartner supposedly gets the rewards. But in factthe game shows that at some point, nobodycooperates anymore and consequently,everyone loses out.

The prisoner’s dilemma also demonstratessomething else: in the long term everyonestands to gain when the players cooperate witheach other.

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Minister for Health and Children MsMary Harney TD with IPHA PresidentMr John McLaughlin at the IPHAAnnual Dinner 2006

NEW IPHA PRESIDENT

The prisoner’s dilemmademonstrates that in thelong term everyone standsto gain when the playerscooperate with each other.

THE ABOVE ARTICLE WAS WRITTEN BY

PROF. CLAUDE LE PEN Prof. Claude Le Pen is Professor of economics at the Paris-DauphineUniversity, where he has specialised in healthcare economics since1985. He is founder and Scientific Director of AREMIS Consultants.Le Pen has acted as an advisor to several commissions of the Frenchgovernment and also worked as an expert for the European Union inpublic health issues. He is President of the “Collège desEconomistes de la Santé” and a member of the editorial boards ofseveral scientific journals.