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					                                  a nual Meetings
prague            29 th june 2006       n° 3 of 4 issues
ta k e -h o m e me s s ag e f ro m t h e P resident

efPia priorities 2006 - 2008
W     hile thanking EFPIA
      membership for the
confidence in electing
                                                                                                Industry and governments should be
                                                                                                talking about health needs for the next
                                                                                                10-20 years, not just cost containment
                                                                                                                                              • Improve patient access to new innova-
                                                                                                                                                 tive medicines: the time needed for set-
                                                                                                                                                 ting reimbursement prices at national
him for another year as                                                                         over the next 6 months.                          level must be shortened, in line with
President, Dr. Franz Humer                                                                    • Industry and governments should agree            the time limits set by the Transparency
stressed the fact of conti-                                                                     on a strategic agenda for health and for         Directive. In addition, co-payment mod-
nuity in a changing politi-                                                                     the development of new medicines, so             els and lower generic prices should cre-
cal and regulatory environ-                                                                     that unmet needs are addressed, disease          ate headroom for financing innovative
ment. He pointed to the                                                                         priorities are clear, and patients get           drugs.
2005 Report of the High                                                                         access to medicines that improve their           As a fourth priority, EFPIA will estab-
Level Group on Innovation                                                                       lives.                                        lish the recently revised EBE organisation
and the Provision of Medi-                                                                                                                    within EFPIA as the true representative for
cines, commonly known                                                                           With these four principles in mind, Dr.       the European Biopharmaceutical Enter-
as G10, which produced 14                                                                     Humer laid down EFPIA priorities for the        prises. Its new structure and re-defined
recommendations for rein-        Dr. Franz B. Humer                                           coming two years:                               mission should make us reach this objec-
forcing the competitive-                                                                      • Implement the Innovative Medicines            tive rapidly.
ness of the Europe-based pharmaceutical             ernments’ desire for objective criteria     Initiative – to become a Joint Technol-          Finally, EFPIA will continue to unroll
industry. There was a shared vision and a           to assess the value of innovative medi-     ogy Initiative: EFPIA wants to get the        the communication and partnership pro-
shared commitment to act.                           cines.                                      IMI approved as a Joint Technology Ini-       gramme. In that context, full implemen-
                                                                                                tiative, a separate legal entity run by the   tation of the revised code of marketing
  However, in many Member States, the          Deliver sustainable funding                      Commission and the association. This          practices is essential. In thanking EFPIA
focus is still on cost containment. There      mechanisms                                       will need full commitment and joint           membership for their full support and
are few signs for faster patient access to     • Society needs to explore new funding           advocacy with the European Parliament,        commitment, Dr. Humer encouraged eve-
new medicines. Health Technology Assess-         approaches and move away from gov-             the Council – including national compe-       rybody to continue to work together on
ment is not used to reward innovation            ernments being the sole purchasers of          tent authorities - and the Commission.        improving the competitive environment
but to put up new hurdles. The tension           medicines in most of Europe. People will     • Improve stakeholders’ understanding           for the industry in Europe and to match
between the single market and nation-            need to accept a higher share of the cost      of the value of innovation: the High Lev-     the ambitious strategic objectives with
al reimbursement system remains, and             of their healthcare.                           el Pharmaceutical Forum will address          concrete actions. w
regulatory hurdles are often hindering         • Health care systems need greater effi-         these issues, in the Working Groups on
patients’ access to quality information on       ciency in the distribution and supply          Pricing and on Relative Effectiveness.
new therapies.                                   chain. Distribution systems for pharma-        EFPIA will put forward recommenda-             Franz B. Humer has accepted a new mandat as
                                                 ceuticals are complex and involve multi-       tions for an optimal balance between           President of eFPIA for the period 2006-2008.
                                                                                                                                               Arthur Higgins and jean-Fraçois Dehecq will
  Dr. Humer recalled a few examples, such        ple steps. The quality of the distribution     enhanced competitiveness and improved
                                                                                                                                               serve as Vice-Presidents.
as the reference price system of Jumbo           system must be ensured, but the present        public health.
Groups in Germany penalizes innovation           level of complexity adds cost, introduces
and rewards imitation.                           inefficiency and increases the risk of
                                                 diversion and counterfeiting.                Code for the Promotion of medi Cines
  In his further talk, he outlined four        • Major cost savings can be achieved with
key principles for strengthening the com-
petitiveness of our industry, which should
                                                 lower generics prices than today. In the
                                                 coming years, medicines with a total
                                                                                              First experiences
remain our focus in the next two years:

Focus on value not cost
                                                 market value of up to € 70 billion will go
                                                 off patent, a huge potential for reward-
                                                 ing innovation if generics are priced at
                                                                                              T   he new EFPIA Code for the Promotion
                                                                                                  of Medicines was formally adopted by
                                                                                              the Board in November 2004. The Code
                                                                                                                                              conduct with respect to events, hospital-
                                                                                                                                              ity, entertainment and gifts. There is also
                                                                                                                                              much progress with raising awareness of
• Deliver fair and appropriate reward for        their real value.                            was effectively upgraded in so far as rules     the new rules, both within companies and
  innovation and therapeutic progress.                                                        are more detailed, stricter both in sub-        vis-à-vis healthcare professionals.
  In today’s cost driven climate, prices       Support a stronger science base                stance and enforcement. It also provides
  for reimbursement are too often based        • Industry must increase its efforts for a     for the involvement of the EFPIA Board on         On the other hand, some companies are
  on cost containing considerations only.        stronger environment for biopharma-          an annual basis. EFPIA associations have        moving to new areas (“soft spots”), such as
  Such policies cannot reward innovation         ceutical R&D in Europe. It will make the     revised their national Code so as to comply     border-line disease awareness campaigns,
  appropriately.                                 companies more competitive and bring         with the changes brought to the EFPIA           inadequate promotional material and
• Secure early patient access to new thera-      benefits to patients and society through     Code by the set deadline of 31 December         “grey” zones between clinical trials and
  peutic options through faster regula-          more effective drug discovery and devel-     2005 and even earlier. In most of the new       post-marketing studies. Unsubstantiated
  tory approval of innovative medicines          opment.                                      Member States, the Code has been co-signed      claims about medicinal products were the
  and improved national price controls         • The IMI project, co-developed with DG        by the generic companies. It is positive that   most important issues reported for 2005.
  systems. In December 2004, 48% of medi-        Research, on bottlenecks in biomedical       many associations have engaged in talks
  cines licensed between June 2000 and           research such as predictive pharmacol-       with the national Medical Association for          According to the EFPIA Code Commit-
  June 2004 were unavailable in most EU          ogy, predictive toxicology, identification   adoption of common ethical standards,           tee there is a certain need to move these
  countries.                                     and validation of biomarkers, will be        along the lines of the Joint Declaration        issues forward with the following Code
• Allow full competition for medicines           crucial.                                     between EFPIA and the Standing Commit-          revision. Also, general management still
  that are neither purchased nor reim-         • EFPIA and its members must seek full         tee of European Doctors.                        needs to intensify communication with
  bursed by the State. This principle is key     support from EU-Governments in the                                                           the field forces and in turn down to the
  if one wants to balance Member States’         final EU budget discussions. The indus-         At the annual EFPIA Code Committee           medical representatives. It is also impor-
  need to control their health care budg-        try should not miss a great opportunity      Meeting of 23 May 2006, the national asso-      tant to work on obtaining a level playing
  ets with companies’ vital interest in          to upgrade Europe’s science base in bio-     ciations’ annual reports allowed members        field as implementation of the Code is
  business flexibility.                          medical research.                            to share and compare their experience.          not yet applied consistently throughout
• A focus on value includes timely, trans-                                                    Apparently, there is increased commit-          the national associations. The first Annual
  parent and scientifically robust evalua-     Keep talking                                   ment from the companies to meeting the          EFPIA Code report will be submitted to the
  tion, with the goal of better healthcare,    • Future health priorities need much           standards of the Code of Practice. There        Board in September 2006. w
  not rationing or delay. We share gov-          earlier and higher quality discussions.      is notable progress in terms of companies’
2      a nual Meetings
                                        2006                                                                                   prague                29 th june 2006        n° 3 o f 4 i s s u e s

he a lt h & th e l i s b o n ag e n da

high returns on health investment
I  n 2000 in Lisbon, the assembled heads of
   state of all EU countries signed a decla-
ration committing themselves to making                    Human capital, in the form
                                                                                                        is well established that the level of gross
                                                                                                        domestic product devoted to healthcare
                                                                                                        increases with overall income levels. As
                                                                                                                                                           later disability affect individuals in earlier

the EU the most competitive and dynamic                                                                 income levels rise, citizens wish to spend           Much more would be invested now in
economy in the world by 2010. At the mid                  of a healthy, well educated                   more on healthcare and this results in             healthcare, were there more confidence in
point in time between that statement and                    working population is                       both increased private expenditure and             payback. The level of individual education
its proposed target date the full extent of                                                             expectations of improved public provision.         also plays a role. People who understand
the challenge ahead is now clearer in two                  an essential prerequisite                    A policy approach that is merely based on          the integrated approaches to prevention,
regards.                                                     for economic growth.                       managing healthcare costs neglects this            screening and treatment and who are
                                                                                                        input to future economic growth.                   aware of the right points of reference for
  Firstly, the competitive challenge from                                                                                                                  their condition, are able to identify what
large middle-income countries, such as                 duce economic returns comparable with               Increased investment is also an intel-          should be done and what results can be
China and India, with high single digit                other uses of resources. In economic terms,      ligent response to demographic change. A           expected. Although in principle the crucial
economic growth rates is now visible to                weaknesses in both the funding and provi-        combination of several decades of declin-          role of public education programmes is
all. The competitive advantages in terms               sion of healthcare constitute a significant      ing birth rates and improved longevity has         well understood by specialists, their value
of labour costs that new Member States                 constraint upon competitiveness.                 resulted in confronting societies with two         relative to other spheres of national activ-
enjoyed for a time are not a basis for                                                                  components of cost escalation: firstly, the        ity does not appear to be well understood
long-term growth. Secondly, as the global                 Human capital, in the form of a healthy,      growing burden of direct healthcare costs          by political leaders.
competition increases Europe will need to              well educated working population is              and secondly, a social service cost to cover
become ever more productive to maintain                an essential prerequisite for economic           residential care for the elderly frail popula-       The shifting of funds and resources away
existing standards of living. It is a given,           growth. Many eminent economists have             tion. The social adaptations required are          from the expensive in-patient sector in
that well educated, healthy work forces                explored the relationship between eco-           widely discussed. Increased life expect-           favour of higher quality, professional pri-
create favourable national environments                nomic status and health status of nations.       ancy is a given for EU citizens but one            mary care services is proving a slow and
to attract inward investment.                          It is also self-evident that greater wealth      cannot foresee the condition in which the          painful process. However, it is becoming
                                                       enables increased commitment to health           additional life-years will be lived and par-       increasingly obvious that it will be impos-
  Thus, the simplest answer to why govern-             care expenditure. The two effects work           ticularly the proportion of life that will be      sible to respond to growing public expecta-
ments should invest in health care is that             together whereby both advance through            spent in bad health. But one can prepare to        tions within the existing healthcare mod-
adequate investment in health may pro-                 a mutual dependence upon each other. It          it as it is clear that many determinants of        els. w

m e d iC i n e s f o r m a n k i n d

Publication of volume 4
T   urning a scientific theory into a new
    medicine takes around a decade. Dur-
ing this time, computer models of new
                                                       risks, the potential new medicine will be
                                                       studied in people.
                                                                                                        patient within a few days
                                                                                                        as the infection is eradi-
                                                                                                        cated. However, in chron-
                                                                                                                                                                                     Despite these com-
                                                                                                                                                                                   plexities, the number
                                                                                                                                                                                  of new medicines
molecules will be studied, thousands of                  Out of 10 to 15 compounds entering             ic diseases the trial may                                                 reaching the public has
variations will be investigated in the test            Phase 1 studies, only one is likely to sur-      last a year or more and                                                  remained steady for the
tube and a small number will eventually go             vive through to authorisation. Also, the         involve long-term follow-                                                last ten years at around
on to be studied in animals.                           time scales for the above studies are very       up to verify that clini-                                                 35 per year.
                                                       variable. Thus, if a new compound is an          cal benefits persist over
   Then, if doctors and scientists are con-            antibiotic for urinary tract infections, a       time.                                                                  Medicines research has
fident that they can do so without undue               positive result will be apparent in each                                                                              developed powerful new
                                                                                                                                                                             tools over the last dec-
                                                                                                                                                                            ades. The EFPIA brochures
 M e d i c i n e s F o r M a n k i n d — d i seases Covered by the bro Chures                                                                                               “Medicines for Mankind”
                                                                                                                                                                            attempt to give a snapshot
    Volume 1                                Volume 2                             Volume 3                           Volume 4                               of where we stand now and what may lie in
    May 2003                                May 2004                             May 2005                           May 2006                               store over the next years.

    Aids                                    Allergy                              Acne                               Addison’s Disease                        The publication gives answers to: What
    Alzheimer’s Disease                     Atherosclerosis                      Age-related Macular Degeneration   Alpha-1 Antitrypsin Deficiency         is the disease? Who gets affected? What
    Asthma                                  Attention Deficit Syndrome           Alcohol Dependence                 Anaesthesia                            treatment is available? What is in the
    Bacterial Infections                    Benign Prostatic Hyperplasia         Anaemia                            Ankylosing Spondylitis                 pipeline? And what can be expected from
    Cancer                                  Contraception                        Anxiety                            Chagas Disease                         the future? Volumes #1, #2 and #3 of
    Cardiac Arrhythmia                      Glaucoma                             Diarrhoea                          Cushing’s Disease                      “Medicines for Mankind” were published
    Chronic Obstructive Pulmonary Disease   Gout                                 eclampsia                          Hypertrophic Cardiomyopathy            in 2003, 2004 and 2005, respectively.
    Congestive Heart Failure                Growth Problems                      endometriosis                      Insomnia
    Cystic Fibrosis                         Haemophilia                          erectile Dysfunction               Legionnaires’ Disease                    Since June 15, 2006, volume #4 with
    Depression                              Infections by Herpes Group Viruses   Filariasis                         Lyme Disease                           another 25 chapters is available. The
    Diabetes                                Infertility                          Hypogonadism                       Melanoma                               close look into 25 clinical pictures from
    epilepsy                                Inflammatory Bowel Disease           Inherited Metabolic Disorders      Meningococcal Meningitis               Addison’s Disease to Wilson’s Disease also
    Fungal Infections                       Influenza                            Irritable Bowel Syndrome           Mumps                                  makes it clear that the genetic revolution,
    Hypertension                            Kidney Disease                       Leprosy                            Mycosis Fungoides                      the progress in information technology
    Ischaemic Heart Disease                 Malaria                              Lupus erythematosus                Pancreatic Insufficiency               and other factors are changing the picture
    Leukaemias and Lymphomas                Motor neurone Disease                Myasthenia Gravis                  Poliomyelitis                          of research and development at an ever
    Migraine                                Obesity                              nausea                             Restless Legs Syndrome                 faster pace.
    Multiple Sclerosis                      Osteoarthritis                       Paget’s Disease                    Sarcoidosis
    Osteoporosis                            Pain                                 Pulmonary Hypertension             SARS                                     With volume #4 the series is coming
    Parkinson’s Disease                     Peripheral Vascular Disease          Rabies                             Scleroderma                            to an end. Altogether, 100 diseases are
    Peptic ulcers                           Psoriasis                            Respiratory Distress Syndrome      Sexually Transmitted Diseases          described (for details see attached table).
    Rheumatoid Arthritis                    Thrombosis                           Sleeping Sickness                  Spinal Cord Injury                     The French and German versions of “Medi-
    Schizophrenia                           Tuberculosis                         Thyroid Diseases                   Tick-borne encephalitis                cines for Mankind” volume #4 will be
    Stroke                                  urinary Incontinence                 Tobacco Addiction                  Typhoid Fever                          available in October 2006. w
    Transplantation                         Viral Hepatitis                      Vitreous Haemorrhage               Wilson’s Disease
                                                                                                                                                           Also available on CD-rom.
                                                                                                                                                               a nual Meetings                                              3
            prague             29   th
                                         june 2006        n° 3 of 4 issues                                                                                                                      2006

an t i - Co u n t e r f e i t i ng o f me d i Ci nes

Cross federation action plan
W     ithin the context of industry’s actions
      to counteract the growing phenom-
enon of counterfeit pharmaceutical prod-
                                                     examples of coun-
                                                     terfeit products hav-
                                                     ing been found with             The problem of counterfeit
                                                                                                                              nologies. The EFPIA
                                                                                                                              Board, in November
                                                                                                                              2005, adopted the
                                                                                                                                                                       It remains necessary to train govern-
                                                                                                                                                                     ment officials in all parts of the world to
                                                                                                                                                                     help them detect counterfeit medicines
ucts, the subject has been raised at high lev-       the wholesalers, the                                                     recommendation to                      and to collaborate closely with other inter-
el within the industry associations EFPIA,           retail pharmacies
                                                                                   medicines is seen as a global              support a 2D (Data                     ested bodies such as trading standards
IFPMA, PhRMA and JPMA. An informal ad-               and over the inter-            problem that requires local,              Matrix) system as                      offices, customs, police and judges.
hoc Group was set up in autumn 2005                  net in nearly all EU                                                     a standardised and
with the mandate to assemble in a coordi-            Member States. So,             national and international                unique coding of                          The third area of action comprises the
nated manner the respective industry asso-           it will be useful to                       strategies.                   medicines system                       increasing public and policy maker aware-
ciations’ objectives and action plans in the         share experience                                                         across the EU. The                     ness of the issue. Industry’s commitment
fight against counterfeit medicines.                 from other geo-                                                          purpose is to avoid                    should be made better known while the
                                                     graphic areas and to coordinate strategies. different coding solutions being adopted                            main responsibility for information must
  The main purpose of industry is to help                                                             in the EU Member States which would                            lie with the public authorities. Informing
ensure the authenticity of pharmaceutical               The ad-hoc Group has identified three drive up productions costs and limit pro-                              patients should be done in a balanced way
products by reviewing and recommend-                 major common industry goals and objec- duction speed.                                                           without causing a loss of confidence in the
ing pro-active innovative approaches and             tives which require involvement at the                                                                          healthcare system, through education and
developing objectives and strategies to              various stages of the supply chain:                The second element refers to the                             encouragement to obtain supplies only
safeguard against counterfeiting.                                                                     strengthening of laws and enforcement                          from authorised sources and reporting any
                                                        The first is to ensure the integrity of prod- to deter counterfeiters. Industry has, since                   suspicious products to the local authori-
   The problem of counterfeit medicines              uct in the legitimate supply chain which the start, spoken in favour of tougher crim-                           ties. To conclude, it is believed that this
is seen as a global problem that requires            may be done through seeking supply chain inal penalties including fines and impris-                             co-ordination process will enable faster
local, national and international strategies.        protections individualized to each country onment that could act as a real deterrent                            progress, within effective alignment while
For example, the extent of the problem in            and the development of plans for the use of vis-à-vis counterfeiters.                                           avoiding duplication. w
Europe is hard to assess but there are a few         appropriate and viable supply chain tech-

fa k e P h a r m aC e u t iC a l s

increase in counterfeit anti-malarial medicines
I  n a paper published in the Public Library
   of science journal PLoS Medicines on
13 June 2006, a group of international
                                                                                                                malaria treatment in Africa. Authorities
                                                                                                                estimate that 130 million courses of ACT
                                                                                                                will be used in Africa in 2006.
                                                                                                                                                                     $500 million a year to ensure that ACTs
                                                                                                                                                                     provided through the private sector are
                                                                                                                                                                     relatively inexpensive and locally afford-
researchers reports a worsening epidemic                                                                                                                             able so there is no financial advantage in
of sophisticated anti-malarial drug counter-                                                                       “The high cost and shortage of ACT pro-           unwittingly purchasing a fake.
feiting in southeast Asia and Africa which                                                                      vide a favourable situation for the spread
is increasing the likelihood of drug-resist-                                                                    of fake artemisinins that could put the                In related research, several of the authors
ant parasites, yielding false-positive results                                                                  lives of thousands of African children at            are studying new, high-throughput screen-
on screening tests and risking the lives of                                                                     risk,” the authors write. They urge authori-         ing techniques to detect and quantify the
hundreds of thousands of malaria patients.                                                                      ties to implement tighter controls on drug           contents of counterfeit anti-malarial drugs
The researchers prompt to urge national                                                                         importation, as well as a subsidy of up to           and other fake pharmaceuticals. This
                                                     Malaria is a widespread international problem, primarily
and international authorities to combat              in poor and developing countries in the tropics.
the problem with stringent regulations,
law enforcement and the provision of inex-           artesunate in patients taking counterfeit                   treatment s for diseases of Pover t y
pensive medicines to undercut the coun-              products will greatly increase the risk
terfeiters.                                          for the selection and spread of malaria                     advance price or purchase commitments
                                                     parasites that are resistant to artemisi-
  Malaria is a widespread international              nin derivatives. That could lead to a loss                     new medicines and vaccines are needed            • The most difficult challenge is getting the
problem, primarily in poor and develop-              of effectiveness for these essential medi-                  for tackling diseases which predominantly             price right. Too high a price would result in
ing countries in the tropics. Each year,             cines and an avoidable failure of malaria                   afflict poor populations in low- and middle-          wasted public finances, too low may result
about 1.5 million people – mostly chil-              control, they write. In addition, the pres-                 income countries. However, the lack of effective      in no company response. The upper price
dren – die of malaria even though genuine            ence of small quantities of artesunate in                   demand or market for these products means             should be based on the societal benefit of the
anti-malarial drugs are quite effective.             tablets may mean that the Fast Red dye                      current investment in research and development        product, including estimates of the monetary
One of the most efficacious medicines                test, widely used for screening the quality                 is insufficient to meet the need for them.            value of the health gain.
is artesunate derived from the Artemisia             of artesunate tablets, yields false-positive
annua plant native to China.                         results, depending on how much artesu-                         Many have advocated cost-reducing (push)         • There should also be provisions for second
                                                     nate is present in the fakes.                               and market- or revenue-enhancing (pull) incen-        and third entrants. Competition in research
   The percentage of over-the-counter coun-                                                                      tives to tackle this problem. Advance price           and development needs to be encouraged to
terfeit artesunate tablets containing no               Also, many fake artesunate tablets con-                   or purchase commitments (APPCs) funded by             induce further development of the original
active ingredient apparently increased               tain other drugs, possibly because the                      international agencies and governments offer          product. This means covering the R&D costs
from 38 to 53 percent in Southeast Asia              counterfeiters are trying to further deceive                one way forward. Theoretically APPCs enhance          of subsequent entrants, at the risk of dimin-
between 1999 and 2004, according to the              patients and doctors by producing a pla-                    markets by guaranteeing companies either a            ishing incentives for first entrants.
authors. In some countries, the major-               cebo effect. For example, some of the coun-                 preset price for quantities purchased, or a mini-
ity of the available artesunate is fake.             terfeit tablets contained acetaminophen                     mum currency amount for an approved product         • Finally, the agent cannot be seen to pay the
Meanwhile, identifying counterfeit tablets           that would reduce a fever, or the antibiotic                that meets preset specifications.                     companies, only to find products left in ware-
has become increasingly difficult as coun-           erythromycin, or even early-generation                                                                            houses. Support by the agent, companies
terfeiters have implemented sophisticated            anti-malarials that are no longer effective.                Five key elements need to be taken into               and other stakeholders need to work with
manufacturing and packaging strategies               The authors also cite serious implications                  account:                                              the relevant countries in advance of regula-
-- such as including low, but ineffective,           of this public health problem for tourists                  • There must be a credible commitment to cov-         tory approval to ensure future take up of the
levels of the proper active substances and           in malaria-prone countries. Visitors often                    ering the total costs for research and devel-       product.
applying counterfeit holograms to packag-            buy unregulated artemisinin derivatives                       opment, including out-of-pocket, opportunity
ing -- to deceive investigators and consum-          in the tropics or on the Internet. It is inevi-               and failure costs. Companies must believe           APPCs have the potential to be a powerful
ers.                                                 table that counterfeit artesunate will seep                   that a promise made now will still hold when      tool and should be tried. The correct structure
                                                     into this trade, the authors predict.                         their product finally reaches the market.         and design may only be determined through the
  Serious implications exist for the rela-                                                                                                                           process of taking action to set one up.
tively new practice of incorporating inef-             The greater concern, they note, is for                    • The agents of APPC must clearly specify
fective levels of active ingredients in artesu-      sub-Saharan Africa. Since 2001, artemisi-                     what kind of product they will pay for and        Taken from the summary of a paper by Adrian Towse
nate tablets, the authors note. Exposure of          nin derivative-based combination therapy                      what milestones the company producing the         and Hannah Kettler, published in the Bulletin of the
                                                                                                                                                                     World Health Organization
malaria parasites to low concentrations of           (ACT) has increasingly become the first-line                  product must achieve to win the contract.
4     a nual Meetings
                                   2006                                                                                              prague                 29 th june 2006            n° 3 o f 4 i s s u e s

Co m m u n i t y Pat e n t

the future patent policy in europe
I n an attempt to revive the proposal
  for a Community Patent Commissioner
McCreevy has initiated a public consulta-
                                                  able and competitive in terms of cost,
                                                  high quality and should make use of and
                                                  coexist with the present European patent
                                                                                                          pean Patent Litigation Agreement (EPLA),
                                                                                                          to improve the existing European Patent
                                                                                                          system (under the Munich Convention).
                                                                                                                                                                        Furthermore, EFPIA proposes that the
                                                                                                                                                                     national courts have parallel jurisdiction
                                                                                                                                                                     as long as necessary to govern existing
tion on the future patent policy in Europe.       system. The Community Patent should                     EFPIA, which is supportive of the proposal,                patents, rather than for a transitional
The major two issues on the agenda are:           guarantee legal certainty and high qual-                seeks to get further assurance on and                      period of seven years seen as too short,
how to reach agreement on the long await-         ity decisions for both infringement and                 improvements of the possible working of                    as time will be needed to evaluate the
ed Community Patent and /or how to                validity issued by providing an appropri-               the system. EFPIA’s proposed policy is that                performance of the court. The EFPIA pro-
improve the existing European system?             ate court system.                                       EPLA should not apply to existing Europe-                  posed policy points have been reflected in
                                                                                                          an patents unless agreed by plaintiff and                  its response to the Commission Question-
  On the Community Patent, EFPIA has                Apart from the Community Patent, is                   defendant (e.g. covering existing commer-                  naire. The Commission will present the
reiterated the view that it needs to have a       the setting up of a centralised court sys-              cial products), owing to the risks posed by                findings of its consultation at a Public
truly unitary character for the whole EU          tem governing patent infringement across                a centralised unilateral revocation action                 Hearing on 12 July 2006. w
territory. In addition, it has to be afford-      the EU-25, as proposed under the Euro-                  from the outset.

ef P i a faC t s a n d f i g u r e s                                                                     The pharmaceutical industry in Europe Key data
new edition 2006                                                                                             indusTrY (efPia total) (*)                   1990              2000              2004                2005
                                                                                                             Production                                   60,220            121,471           160,769        170,000 (e)
e   urope has a great deal to gain in health
    and economic terms from a strong and
competitive indigenous research-based
                                                  the US market grew by 12.5% per annum,
                                                  well ahead of Europe which showed a non-
                                                  weighted average growth of 7%.
                                                                                                             exports                                       23,180            90,935           165,003        178,000 (e)
                                                                                                             Imports                                       16,113            68,841           132,853        144,000 (e)
pharmaceutical sector. The research-based
pharmaceutical industry is one of the               These market evolutions have particu-                    Trade balance                                  7,067            22,094            32,150           34,000 (e)
remaining leading high technology indus-          larly benefited US-based companies, which                  R&D expenditure                                7,766            17,849             21,106          21,700 (e)
tries in Europe, amounting to about 18%           have significantly increased their share
of all business research and development          in development and sales of new medi-                      employment (units)                          500,879           538,317            612,114        615,000 (e)
(R&D) investments and about 3.5% of the           cines. However, in 2005, the European                      R&D employment (units)                        75,760            88,524           102,222        103,000 (e)
total EU manufacturing value added.               market outpaced the US market in terms
                                                  of growth, for the first time in more than                 Pharmaceutical market value
                                                                                                                                                          43,005             86,812           120,007         127,500 (e)
   Since the early 1990s, the                     a decade.                                                  at ex-factory prices
research-based pharmaceuti-                                                                              Values in € million unless otherwise stated - (*) Data relate to EU-25, Norway and Switzerland since 2004
cal industry in Europe has                                                   The fragmentation           Source: EFPIA member associations (official figures) - (e): EFPIA estimate - Eurostat (EU-25 trade data 1995-2005)
been losing competitiveness                                               of the EU pharmaceuti-
with respect to its main com-                                            cal market results in a
petitors, in particular the US.                                          lucrative parallel trade        efP ia annual meetings 2007

                                                                                                         From 30 th May
Data for 2004 and prelimi-                                              which benefits nei-
nary figures for 2005 con-                                              ther social security nor
firm Europe’s lack of attrac-                                           patients but deprives
tiveness as a location for
pharmaceutical R&D invest-
                                                                       the industry from addi-
                                                                       tional resources to fund
                                                                       R&D. Parallel trade was
                                                                                                         to 1st June 2007
                                                                      estimated to amount to                “So far,“ says Brian Ager, Director Gen-                 tribute positively to the ongoing debate.
  Between 1990 and 2005,                                              € 4,200 million (value at          eral of EFPIA, “Annual Meetings 2006 in                     Czech liveliness and hospitality, perfect
R&D investment in United                                              ex-factory prices) in 2004.        Prague have provided a perfect opportu-                     meeting venues and even pleasant weather
States grew 4.6 times while                                                                              nity for health policy-makers and regula-                   have all been providing ideal conditions
in Europe it only grew 2.8                                            It would be too simplis-           tors, Community, national and regional                      for interesting dialogues. At this point I
times. Today there is rapid growth in the                          tic to attribute the relative         authorities, patient representatives, aca-                  would like to take the opportunity and
research environment in emerging econo-           lack of attractiveness of Europe for phar-             demics, journalists and senior executives                   thank MAFS, the Czech Research-Based
mies such as China and India. The United          maceutical R&D to one single factor. Con-              of the pharmaceutical industry to meet                      Pharmaceutical Association for the excel-
States still dominates the biopharmaceuti-        tributing to this problem are the economic             and exchange views on a wide range of                       lent preparatory work for the meeting as
cal field, accounting for the three quarters      and regulatory framework, the science                  issues.                                                     well as the warm welcome MAFS extended
of the world’s biotechnology revenues and         base, the investment conditions, and soci-                                                                         to our visitors.
R&D spending.                                     etal attitudes towards new technologies.                 The theme of the Annual Meetings
                                                                                                         “Medicines Research – Creating Health                         I would also like to express my sincere
  In 2005, North America accounted for              These figures and other facts have been              and Wealth in Europe” has closely fol-                      appreciation to all EFPIA staff for their
47% of world pharmaceutical sales against         put together in the 2006 edition of EFPIA´s            lowed the Commission’s designation of                       dedicated work and attentiveness which
30% for Europe. According to IMS Health           brochure “The Pharmaceutical Industry in               the High Level Pharmaceutical Group. The                    made the General Assembly, the break-out
data, 66% of sales of new medicines mar-          Figures” which is available at the registra-           meetings, workshops and the symposium                       groups, the scientific meetings and the
keted since 2001 are generated on the             tion desk. w                                           have been to underscore that industrial                     roundtable discussions a great success.
US market, compared with 24% on the                                                                      policy and health policy need to work
European market. Between 1994 and 2004,                                                                  in tandem, amid growing concern about                         It was a real pleasure to host our visi-
                                                                                                         society’s ability to provide universal access               tors in the Czech capital. Looking ahead
                                                                                                         to healthcare. Only a viable economy will                   I would like to announce date and venue
    programme Friday, 30th june 2006                                                                     generate the financial resources to sustain                 of EFPIA Annual Meetings in 2007. They
                                                                                                         the European model.                                         will take place at Brussels, the EU capital,
  For EFPIA members only                          08.30-11.00 - early start!                                                                                         from Wednesday, 30 May to Friday, 1 June,
  08.30-10.00                                     eFpia Board Meeting - for eFPIA Board                    “EFPIA membership”, concludes Mr.                         next year. w
  Bureau Meeting [cancelled]                        members only at Marriott Hotel                       Ager, “has seized the opportunity to con-
                                                    (Room Bohemia II)
  central & eastern europe Task Force             Open to the public
    open Meeting for eFPIA Membership             11.00-13.30                                              aCknowledgement s
    at Marriott Hotel (Room Bohemia III)          eFpia Workshop “new Approaches to Health-                EFPIA would like to express their sincere thanks to the following partners of the Annual
  09.00-12.30                                       care Funding and Delivery” at Marriott Hotel           Meetings 2006: Arte-Print • CDL • Geursen-Consulting • Czech-In • De Frivole Framboos •
  sTrpc open Meeting for eFPIA Membership           (Room Moravia)                                         Lander Loeckx • MAFS • Marriott Hotel • Megalunatriumviraat • Municipal House • Prague Castle
    at Marriott Hotel (Room Bohemia I)            12.30                                                    administration • Renaissance Hotel • Tine Van Wambeke • traiteurs: Vyšehrad 2000 and Zátiší •
                                                  Farewell Lunch for all participants                      VCP Graphics • Special thanks to Jitka Minxová, Patrik Choděva, John Hess, as well to Jurgen
                                                    at Renaissance Hotel (Room Dvořak)                     Darras and Yves Nulens’ team for their Hercules work.

                                                  chIef edITor Dr. Robert G. Geursen | depuTy chIef edITor Marie-Claire Pickaert (Deputy Director General eFPIA)
                                      desIgn and producTIon  Megaluna, arts+design: Rudi De Rechter (lay-out), Koen de Visscher (coordination) | phoTographer Lander Loeckx
                                           edITor eFPIA, Leopold Plaza Building, Rue du Trône 108, B-1050 Brussels, t: +32 2 626 2555, f: +32 2 626 2566,
                                                with thanks to the eFPIA staff that has contributed in collecting documentation for the production of this newsletter

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