medicines mattermedicines matterThe I r i sh Pharmaceut ica l Healthcare Assoc iat ion N O V E M B E R 2 0 0 5

A new initiative by the pharmaceuticalindustry now enables anyone to monitorthe trials of new medicines and see howthey are progressing. Patients andhealthcare professionals can now refer toclinical trial data on new medicines andvaccines being developed around theworld through a free service linkingstudies from all five continents. Accessto trial data is provided through thewebsite portal, www.ifpma.org/clinicaltrials (see link from www.ipha.iewebsite), which contains more than250,000 links, enabling users to access“non-promotional” information on thestage and progress of trials.

The initiative launched by InternationalFederation of PharmaceuticalManufacturand IBM, provides coverage of ongoing

ers and Associations (IFPMA)

trials worldwide, with extensiveinformation on the medicines beingtrialled, the specific purpose of the trials,the stage they are at, where trials arebeing conducted and more (see box).

“The portal provides doctors, patientsand their families with simple access tothe most complete information on clinical

CLINICAL TRIALSDATA OPENED UP

trials of drugs and vaccines, “ said DrDaniel Vasella, CEO of Novartis andpresident of the IFPMA. “The launch ofthis portal shows the pharmaceuticalindustry’s commitment to fulltransparency in the interests of patientsand healthcare professionals.”

“This is an effective, important and veryvaluable resource for professionals andpatients alike,” said IPHA PresidentConn Clissmann. “Enabling everyone tofind what potentially life-savingmedicines are currently beingdeveloped, and being completely openabout the stages and purpose of trialsthey are undergoing, helps betterinformed decisions to be made aboutthe medicines patients use. By workingto provide easy access to everyone onthe medicines currently beingdeveloped and how our research-basedindustry is showing its commitment totransparency. “This information aboutproducts in development complementsour well-established source of non-promotional information aboutmedicines already approved andavailable in Ireland atwww.medicines.ie.” said Mr Clissmann.

www.ifpma.org/clincialtrialsINFORMATION AVAILABLEIFPMA has designed the website with public in mind, it claims, and extensiveguidance and glossaries are provided to assist searches. The Portal allows two broadtypes of information to be searched for. One is listings (registries) of on-going clinicaltrials, providing access to basic information, including: brief title, description in layterms, trial phase, trial type (e.g. interventional), trial status, trial purpose (treatment /diagnosis / prevention), intervention type (e.g. drug / vaccine), condition or disease,key eligibility criteria (including gender & age), location of trial and contactinformation.

The other broad category of information to which the Portal provides links to, is theresults of completed clinical trials, which are made available in a standard, non-promotional, summary format by various on-line databases. The IFPMA is keen topoint out that this is just the first phase in an ongoing development in “putting usefulinformation into the hands of patients and carers as quickly as possible.”

CALLS FOR GREATERRESEARCH RESOURCESCalls for a greater emphasis and resources

for research were heard at IPHA’s recent

annual conference. “Research should not

be something limited to a doctor’s spare

time,” said Dr Brendan Buckley,

Department of Pharmacology and

Therapeutics at UCC and member of the

IMB’s Advisory Committee. The current

funding environment was inadequate, Dr

Buckley claimed – “… with researchers

living from grant to mouth.” Innovation in

the development and delivery of medicines,

meanwhile remained vital in order to end

“the enormous unrelieved burden of

disease”, creating a need for new

diagnostics that demanded the

collaboration of the industry, academia,

patients and government.

“The choice for Ireland is producing bulk

chemicals and competing with Bangladesh -

or ‘innovation’,” said Dr Buckley.

Mr Michael Griffith of Fighting Blindness,

claimed that it is patients who are likely to

suffer most in the resulting wait for new

cures: “Of 30,000 known human conditions

only a quarter of them are treatable.

Minister Micheàl Martin, TD with IPHA President ConnClissmann at IPHA’s conference The Search for InnovativeSolutions in Irish Healthcare.

(continued on page 4)

EUROPEAN PHARMA UNDER THE WEATHEREurope’s pharmaceutical industry is in need of medication itself, according to a new report fromThe European Commission published earlier last month. Declining R&D activity has already seenthe lion’s share of new medicines development move to the US, and a number of reasons arecited: mounting price pressures, inadequate intellectual property protection; shorter exclusivityperiods; poor co-ordination of private and public funding and a low information exchangebetween academic and business activities are all mentioned as contributory factors to a decline inthe industry’s competitiveness in Europe.

Only one compound in 13 now reaches the market, compared with one in 8 between 1995 to2000, according to the Report. The good news is that bolstering the industry is now a priority ofEnterprise Commissioner Gunter Verheugen. “The continued lack of international competitivenessand the economic and strategic significance of this industry to the European economy as a wholemake a more comprehensive approach worth considering,” says the Report. The pharmaceuticalindustry accounts for 2.8% of EU industrial production, while ‘value added’ per employee isaround a third higher than in other high tech sectors. Mr Verheugen has suggested theestablishment of a Pharmaceuticals Forum made up of figures from industry and government plusstakeholders such as patient groups and health professionals. Biotech is also seen as a growtharea, with the Commission estimating that bio accounts for 20% of marketed medicines and 50%of those in the pipeline.

EFPIA INTRODUCESNEW MARKETINGCODE OF PRACTICE

The European Federation of

Pharmaceutical Industry

Associations (EFPIA), has

introduced a revised code of

practice in the promotion of

new medicines. EFPIA, of

which IPHA is the Irish

member, represents all of the

continent’s national

pharmaceutical healthcare

associations as well as a number

of multinational pharmaceutical

companies, and Ireland will be

expected to comply with the

new stipulations in its own

version of the Code. The sixth

edition of IPHA’s Marketing Code

is currently under review and

will be implemented shortly.

The new European Code of

Practice, is intended to

harmonise standards of best

practice in pharmaceutical

marketing throughout Europe.

IPHA NEWS

A new report from the United Nationsmeanwhile shows that the availability ofresearchers is now a key driver in attractingforeign direct investment. The World InvestmentReport claims that the reasons for companiesinvesting have changed considerably, and thatcost and availability of research manpowerincreasingly influences their decision to invest.This same theme was echoed at the IPHAconference – see page 4 – with R&D investmentbeing singled out as a key component incontinuing the success of the industry here.

Meanwhile, in a recent RTE interview, theGovernor of the Central Bank, John Hurley, saidCINEMA FICTION

August saw the US release of

the film ‘The Constant

Gardener’, which is scheduled

for a November release here.

The film includes Ralph

Fiennes and Rachel Weisz and

has been tipped as a potential

award winner by the American

press. Medicines Matter

makes mention of it, as the

pharma industry too plays a

key role in the cast, with

suggestions of manipulated

trials, mass death, destruction

and much evil. As with the

actors appearing in the film,

‘The Constant Gardner’ is a

work of fiction, (Ralph

Fiennes, for example is not

really married to Rachel

Weisz).

Some media coverage can be

expected.

PHARMACEUTICAL INDUSTRY’SCONTRIBUTION TO THE DEVELOPING WORLD

The pharmaceutical industry has from time to time been criticised, and indeed sometimes vilified,for its role in the developing world. The new film “The Constant Gardener” sees some of the oldcharges rehashed.

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 totackling the crisis. As noted by the UN Secretary General Kofi Annan poverty and a lack of basichealthcare infrastructure to distribute medicines are the greatest barriers to access to medicines inthe developing world.

95% of the medicines on the World Health Organisation (WHO) essential medicines list are off-patent. TB, malaria, polio and measles are killing thousands of people, yet the medicines to curethem are mostly out of patent and cheap.

The industry has contributed over $4.1 billion in donatedmedicines and financial assistance to the developing worldin the period 1998-2003. In 2003 alone the total exceeded$1.47 billion. The industry is also involved with hundreds ofpartners such as development organisations, healthcarecharities and Governments in 120 countries on 5 continents.For example the industry is involved in the Global Alliancefor TB Drug Development, a public-private partnershipinvolving the WHO and others to halt the rise and reversethe spread of the world’s oldest infectious disease bydeveloping new and faster-acting tuberculosis medicines.

that an increased R&D capability is vital tomaintaining our standard of living. IntertradeIreland the cross- border body, has alsopublished a report on what’s required forIreland to be one of the top 5 globaleconomies in income terms: ‘Engineering aKnowledge Economy’ recommends closerintegration of industry and third leveleducation, with more investment in research.And The European Commission has justlaunched an ‘upgrade’ to its Lisbon Agendaplans to secure 3% of GDP investment in R&Dby 2010 which includes tax incentives and“greater knowledge transfer between publicresearch and industry”.

FDI LINKED TO RESEARCH CAPABILITY

OVER 6,000 IPHAMEDICINES COMPENDIUMDISTRIBUTED FREEThe IPHA Medicines Compendiumcomprising the SPCs (Summary ofProduct Characteristics) and PIL (PatientInformation Leaflet) for nearly 2,000medicines currently available in Irelandwas distributed to healthcareprofessionals in September. Over 6,000CDs have been distributed by the IPHAto GPs and pharmacists, nationwide withmany thousands of information leafletsfor patients being distributed later thismonth.

INDUSTRY REPORTPUBLISHEDBusiness and Finance magazineproduced IPHA’s Industry Report, whichprovides a cross section of the industryincorporating the views of the IDA, IPHAmembers and other industry bodies,including IBEC’s Pharmachemical Ireland.The thirty page report provides asnapshot of Ireland’s largest exportsector, including a history of its evolution,new statistics and a clear picture of thechallenges ahead. The publication isintended to provide a single reference onthe current state of the sector and itsfuture, and has been distributed to thirdlevel institutions, stakeholders andmembers of both organisations. Thedocument can be downloaded from theIPHA website at www.ipha.ie, and alimited number of additional copies areavailable on request from IPHA offices:amybrophy@ipha.ie

IPHA NEWS

INTERNAL COMMUNICATIONS CAMPAIGNLAUNCHED FOR PHARMA INDUSTRYA multi media presentation kit is being distributed to IPHA members and others for use inindustry sites across the country. ‘The DNA of a Healthier Ireland’ campaign is designed toprovide those working in the industry with a clear picture of how the sector is contributing tothe health and well being of the country. Using the positioning statement: “Medicines Make ADifference – Your Work Makes A Difference”, thecampaign follows requests from IPHA members, and isdesigned to show how different functions combine andcontribute to creating lifesaving medicines. Thepresentation kit, comprising PowerPoint presentationplus extensive notes, aids and display material for theworkplace will be arrive in industry sites throughNovember.

The following text is from a menu card intended fordisplay on canteen tables: “Working inpharmaceuticals is different from other industries.What you produce here helps people get on with

their lives- -– ithelps them fightand preventdisease; it helpsextend their livesand it helps themimprove thequality of thelives they lead.

“Research based pharmaceutical companies have created90% of all medicines; they have helped increase lifeexpectancy by a third and have virtually eliminated killerdiseases such as TB, polio and pneumonia.”

MEDICINES.IE LAUNCHEDThe consumer version of IPHA MedicinesCompendium, medicines.ie is now taking hits.Featuring all the information from theMedicines Compendium, the website isdesigned to provide patients with fast andeasy access to information on their medicines.The site also includes help sections andadvice on using medicines. “It is vitallyimportant to the health and wellbeing of thecountry that this independent information isreadily available, free to both the medicalprofession and to the general public,” saysConn Clissmann of the IPHA. Medicines.ie isavailable on the web without charge and

without advertising or any product promotion. “We in the pharmaceutical industry in Ireland,feel it is very important that such independent information on our products is readilyaccessible and in the public domain,” said Mr Clissmann.

“Some of the information is quite technical, of course, “says Dr Rebecca Cramp, who headsthe project, “but the Medicines Compendium provides the information approved by theregulatory authority, and includes information such as possible side effects; interactions withother medicines etc. When users combine this information with package information leaflets(PILs) that accompany all medicines, the Compendium and medicines.ie provides patientswith a very powerful and useful resource. “

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 O’Grady,Brian Murphy

Publisher:© Irish PharmaceuticalHealthcare Association

Design and production:Slick Fish Design, Dublin

CALLS FOR GREATERRESEARCH RESOURCES(CONTINUED)

CONFERENCE SUMMARY

INNOVATING IRELAND’SFUTURE HEALTHCAREIPHA’s members heard about the challenges andthe possible solutions facing the industrynationally and European-wide at IPHA’s annualconference on September 29th. Innovation inboth the provision of healthcare and the businessof making medicines was the theme of themorning long event, which featured speakersfrom Goodbody’s Stockbrokers, EFPIA, IMB, TCDand patient groups. The meeting was alsoaddressed by Minister Micheàl Martin, TD.

Encouraging Innovation in IrelandProfessor Dermot Kelleher is professor of ClinicalMedicine at TCD and has been heavily involvedin applying academic research and innovation inthe industry here. Ireland’s tradition of medicalinnovation is only now being restored, heclaimed. “We’re getting to a respectable level ofinnovation here,” he said. “The challenge now isdeveloping the right culture… Knowledge here isthe driver of economic growth.”

The timing for creating an innovative capability inIreland for the development of medicines,especially biotech, is now ideal, ProfessorKelleher maintained. Infrastructural investment isnow paying practical dividends; there is a clearinnovative capability in the county’s universities,and just a small number of ‘hits’ – successfulproducts - are required for success. He alsoargues that innovation outsourced to smallercompanies can out perform their more cautiouspatrons. “So the time is right foracademic/industry partnerships” said ProfessorKelleher. “Ideas are key. New technologies levelthe playing field giving smaller companies similarcapabilities to larger ones.”

‘Innovate or Die’ - The ResearchImperative The growing output and contribution of orphanmedicines, was an example of the role smallerinnovation-led pharma businesses couldcontribute to world health, through what DrBrendan Buckley, of UCC described as “dream-driven development process” of high level ofinnovation and low overheads. “Orphandevelopers are often very small with no directfunding and minimum legislation experience,” hesaid, yet they have managed to make a valuablecontribution to world health by bringing eightnew medicines in the last five years, for whichthere had been no previous satisfactorytreatment, with one million patients likely tobenefit. According to Dr Buckley, the need toconsolidate robust intellectualproperty legislation, together with“a change in the brownie pointssystem of academia”; and adequatefunding were vital components tocreating a future for Ireland’smedicines industry.

But perhaps the most fundamentalproblem remains Ireland’s taxationsystem, which encouraged propertyto the detriment of the capitalinvestment needed to makeindigenous businesses work. “This isvery anti-innovative. We really needto change the culture here,” he said.Instead Ireland’s tax regime needs tobe transformed to make capitalavailable for investment in newventures, by penalising theattraction of property investments

and incentivising business investments heclaimed. The current climate of availablefunding was inadequate, he claimed – “… withresearchers living from grant to mouth. Researchshould not be something limited to a doctor’sspare time.”

“Ireland is starting to come up on the radar ofthe industry as being somewhere you can dogood science, “ said Professor Kelleher duringthe summing up, claiming that anentrepreneurial culture was required here togenerate the innovation capability Irelandneeded. “We need lot of ‘little pharma’companies being encouraged to set up here…We’re getting towards respectable levels ofinnovation here the challenge now is developingthe right culture.”

Minister Martin on the Need for Change“This is an industry that has its footprint all overthe country and we are very conscious that notonly do we have to bed down and consolidate ,but we also have to change our activities andmove up the much quoted value chain” , saidMinister Martin at the event.

After visiting pharma companies worldwide, theMinister said the signs for further FDI investmentswere very positive: “The news is good in terms ofpipeline and in terms of the quality and skills inIreland, “he said, claiming Ireland’spharmaceutical capability is viewed veryfavourably overseas. The Minister also pointed tothe role the industry plays in the health and wellbeing of the country: “The contribution ofmedicines is often taken for granted... We needto make more of this connection and challengepeople. As a society we cannot have an ‘each-ways’ bet on this.”

Ireland’s Biggest ExporterIPHA’s President Conn Clissmann, continued themessage, claiming that developing newmedicines is where the future lies for the Irishindustry. “Ireland is now the world’s biggest netpharmaceutical exporter…. I fear we’re in dangerof taking this for granted just because we’vebecome so used to the extraordinary capabilitywe have managed to create here. We spendmore on innovation than any other sector andmore than half of the 24,000 employed in thepharmaceutical sector are third level graduates.Make no mistake that this is the sort of industrythat can lead Ireland’s economy well into the 21stcentury.”

A FULL WRITE UP OF THE CONFERENCE IS AVAILABLE FOR DOWNLOAD FROMTHE IPHA WEBSITE WWW.IPHA.IE

Innovation is definitely needed

and urgently”, says Mr

Griffith.” I think that especially

because of the political

difficulties this problem can

only be tackled by partnership.

Working groups must be

established comprising

regulators, industry, scientist

and patient groups.”

A full conference report

is available from the IPHA

website: www.ipha.ie

Conn Clissmann, IPHA President; Minister Martin; Anne Nolan CEO IPHA,Minister Martin, and Dr Dermot Kelleher of the HSE.