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The Role of Europe in Drug Development

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Title: The Role of Europe in Drug Development


1
The Role of Europe in Drug Development
  • London, Friday 19th October 2007
  • Charles Benson, M.D., Ph.D.
  • Eli Lilly Company
  • Medical Advisor

2
The Role of Europe in Drug Development
  • History (brief)
  • Current -- Diminishing Role of Europe in Drug
    Development?
  • Future
  • What is being done to maintain/ revitalize Europe
    for Drug Development.
  • What else could still be done?

3
Europe has long played a critical role in Drug
Development
  • 1805 -- Friedrich Serturner of Germany isolated
    the pure active ingredient of opium
  • He named the chemical morphine, after Morpheus,
    the Greek god of dreams.
  • This was the first isolation of an active
    ingredient.
  • 17th century -- Jan Baptista van Hellemont,
    physician in Brussels proposed a method to settle
    a dispute over wound treatments.
  • Vitriol (metallic sulfates) versus blood letting
    treatments were to be assigned by lottery to
    several hundred patients.
  • Results were to be judged by number of funerals.

4
Europe has long played a critical role in Drug
Development
  • The first double blind curative trial with
    concurrent controls in the general population in
    modern times.
  • A few years after the discovery of penicillin, a
    London biochemist reported that a product he had
    extracted from another penicillium, Penicillium
    patulinum, was beneficial in the common cold
  • Headlines were More valuable than penicillin?
  • 1943-4 U.K. Medical Research Council undertook a
    randomized, placebo controlled study using over
    1000 patients
  • Results were negative
  • The second trial, carried out in 1947-8 by the
    U.K. Medical Research Council to evaluate
    streptomycin in tuberculosis, is widely accepted
    as the first randomised curative trial.

5
The Role of Europe in Drug Development is still
important
  • European-based pharmaceutical industry makes a
    major contribution to the EU, not just in
    economic terms but also in terms of high quality
    employment, investment in the science base and in
    terms of public health1.
  • In 2004, with a value of output of about 160
    billion (including a trade surplus of 32 000
    million), a contribution to RD amounting to 21
    100 million and more than 612 000 jobs in Europe
    (including 102 200 in RD units), the
    pharmaceutical industry is a key asset for the
    European economy.
  • The pharmaceutical industry is fundamental for
    the goals set in the Lisbon strategy, which aims
    to turn Europe into the most competitive and
    dynamic knowledge-based economy in the world by
    2010.  

1Erkki Liikanen, Member of the European
Commission, responsible for Enterprise and the
Information Society. "Progress on the G10
recommendations for the pharmaceutical sector.
Opening of the Public Forum on the European
Pharmaceutical Sector Brussels, 3 June 2004
6
Current -- Diminishing Role of Europe in Drug
Development?
  • Two decades ago, Americans worried about the
    transfer of RD efforts from the United States to
    Europe2.
  • Currently, the opposite is the concern.
  • During 1996-99, RD spending by the
    pharmaceutical industry in the United States rose
    by 14.1 percent per year in Europe the rate was
    just 8.3 percent.

2N Mattison, AG Trimble and L Lasagna, New Drug
Development in the United States, 1963 through
1984, Clinical Pharmacology and Therapeutics,
March 1988, 43290-301
7
Current -- Diminishing Role of Europe in Drug
Development?
  • High value-added jobs - the US created 42 more
    high value-added pharmaceutical jobs than Europe
    from 1990 to 2001.
  • Corporate research centers - both US and European
    RD expenditures were approximately 10 billion
    in 1992. From 1992 to 2002, US pharmaceutical RD
    expenditures grew by 11 (compounded annually)
    while European expenditures grew by just 8,
    resulting in a substantial shift to the US.

2N Mattison, AG Trimble and L Lasagna, New Drug
Development in the United States, 1963 through
1984, Clinical Pharmacology and Therapeutics,
March 1988, 43290-301
8
Current -- Diminishing Role of Europe in Drug
Development?
  • In 1987-89, 20 percent of the drugs on the market
    in the United States were marketed there first
    most came to market first in Europe.
  • By 1996-98, the percentage marketed first in the
    United States more than doubled, reaching 46
    percent.

9
The Role of Europe in Drug Development
The figure shows the time from approval in the
first market to approval in the second market for
the 71 drugs that received marketing clearance in
both the European Union and the United States
between 2000 and 2005. Adapted from the Tufts
Center for the Study of Drug Development Impact
Report 9, 3 (2007). On average, the FDA approval
came 1 year ahead of clearance by the European
Medicines Agency (EMEA).
10
Current -- Diminishing Role of Europe in Drug
Development?
  • This 'drug gap' is not due to faster FDA
    processing both agencies have an identical mean
    approval time of 15.7 months.
  • Drugs hit the US market first because the
    sponsors choose to submit them there first.

11
Current -- Diminishing Role of Europe in Drug
Development?
  • The advantage of the US is almost wholly due to
    its lack of price controls
  • Investors tend to invest in places where there is
    less control over prices
  • It is always better to do your clinical trials in
    the countries where you plan to market.
  • In 1992, 6 of the top 10 biggest selling
    medicines in the world originated in Europe with
    4 from the USA. In 2002 the situation had
    reversed with 8 of the top selling medicines
    coming from the USA and only 2 from Europe.
  • In 1999, the United States accounted for 57
    percent of the sales from drugs new to the market
    since 1995 Europe accounted for less than half
    that at 25 percent.

12
Diminishing Role of Europe in Drug Development?
2005 Europe population 728 Million 2005 US
Population 298 Million
13
Diminishing Role of Europe in Drug Development?
  • Europe spends 60 less per capita on
    pharmaceuticals than does the US - a gap that has
    roughly doubled since 1992, when European
    governments spent about 30 less per capita than
    the US.
  • US market, which represents the largest and
    fastest-growing share of the global profit pool,
    now 62.

The World Economic Forum For Healthcare Annual
Meeting 2004 Addressing The Innovation Divide,
J Gilbert, P Rosenberg, Bain Company, Inc.
14
Cost Savings? Bain Model
  • In 1992, Germany and the US spent virtually the
    same amount per capita on pharmaceuticals 275
    versus 288.
  • 10 years later a large gap had developed, driven
    by the German government's set reference prices.
  • 2002, Germany spent just 421 per capital -
    nearly 40 less than the US, which spent 685.
  • Bain's model calculated the difference between
    Germany's actual 2002 performance and how it
    would have performed in a system where the
    government exerts less control over drug prices.
  • In effect, it showed whether Germany enjoys a net
    gain or suffers a net loss under the "free rider"
    model.
  • In 2002, Germany saved 19 billion because it
    spent significantly less per capita on
    pharmaceuticals than did the US.

The World Economic Forum For Healthcare Annual
Meeting 2004 Addressing The Innovation Divide,
J Gilbert, P Rosenberg, Bain Company, Inc.
15
Cost Savings? Bain Model
  • Germany lost 3 billion in 2002 as RD investment
    in that country increased by a mere 52 from 1992
    to 2002, while investment in the US increased by
    184.
  • Lost patent values and "network effect" benefits
    equated to an additional 1 billion in total RD
    losses.
  • High value-added jobs - cost Germany 3 billion
    in lost wages (taxes and other multiplier
    effects) in 2002
  • From 1990 to 2001, high value-added employees in
    Germany's pharmaceutical industry fell by 26
    while the US increased by 52.
  • Additional losses related to the loss of high
    value-added jobs, namely economic multiplier
    effect losses, totaled an additional 5 billion.
  • Corporate centers - lost profits totaling 3
    billion in 2002 would have accrued if Germany's
    pharmaceutical industry had kept pace with its US
    counterparts.
  • In 1980, two German firms - Bayer and Hoechst -
    ranked among the world's top 10 drug makers.
    They've now disappeared from the top-ten list.
  • Other related losses, e.g., taxes, corporate
    formation benefits, would bring the aggregate
    loss from the shift in corporate centers to
    approximately 5 billion.
  • Health outcomes - Bain's analysis suggests that
    in 2002, Germany lost nearly 5 billion from
    poorer health outcomes driven by less patient and
    physician access to the most innovative drugs,
    contributing to higher comparable hospitalization
    rates and absence rates from work.

The World Economic Forum For Healthcare Annual
Meeting 2004 Addressing The Innovation Divide,
J Gilbert, P Rosenberg, Bain Company, Inc.
16
Cost Savings? Bain Model
17
Current -- Diminishing Role of Europe in Drug
Development?
  • Other factors
  • TGN1412 trial disaster -- delayed approval for
    biologics trials and induced companies to look
    elsewhere to conduct them.
  • Clinical Trials Directive -- Member countries
    added extra provisions when interpreting the
    Directive into law
  • Increase in bureaucracy and uncertainty
  • Potential extra costs and delays for clinical
    approvals have driven multinational studies
    outside Europe

18
Current -- Diminishing Role of Europe in Drug
Development?
  • Not new news
  • 2001 Europe is losing ground in its ability to
    generate, organise, and sustain innovative
    processes.3
  • Primary causes are lack of competitive national
    markets, fragmented research systems and low
    investment in RD and in the new technologies.
  • 2006 Competitiveness report by the European
    Commission's high-level Pharmaceutical Forum
  • US has established itself firmly as the key
    innovator in pharmaceuticals since 2000.
  • "That dominant position continues to expand... a
    disproportionate share of pharmaceutical RD is
    performed in the US

3Global competitiveness in pharmaceuticals - A
European Perspective. Gambardella, Orsenigo and
Pammolli. Published as Enterprise Paper No 1
2001.
19
Role of Europe in Drug Development What is
being done?
  • G10 process instituted 2001 to review how current
    Community and national pharmaceutical, health and
    enterprise policies can achieve
  • Innovation and competitiveness
  • While ensuring satisfactory delivery of public
    health and social imperatives.
  • The Pharmaceutical Forum was formed as a
    ministerial-level discussion of how to keep
    innovation alive
  • This group was asked to examine some of the most
    crucial and outstanding issues of the G10 process
  • Information to Patients
  • Pricing/Reimbursement
  • Relative Effectiveness

20
Role of Europe in Drug Development What is
being done?
  • The Pharmaceutical Forum
  • Control of expenditure Pricing/Reimbursement
  • Several factors have generated significant
    changes in the pricing and reimbursement
    mechanisms of most Member States during the last
    years
  • Rising expenditure on medicines
  • Inequity of access to medicines
  • Lack of early access to innovative medicines.
  • The progress report seeks to identify, explore
    and exchange information and data on alternative
    mechanisms.
  • The objective of finding a balance
  • Controlling expenditure
  • Improving access to medicines
  • Rewarding innovation

21
Role of Europe in Drug Development What is
being done?
  • The G10 High Level Group on Innovation and
    Provision of Medicines
  • Recommended to examine ways to shorten periods of
    decisions allowing rapid access for patients as
    well as control over the healthcare budget for
    Member States.
  • "The Commission and Member States should, as a
    priority, examine the scope for improving time
    taken between granting of a marketing
    authorisation and pricing and reimbursement
    decisions in order to reduce this time to the
    absolute minimum. The Commission will, in
    parallel, launch a reflection on finding
    alternative ways of controlling national health
    care expenditures including the option of letting
    manufacturers set the prices of new products,
    while negotiating appropriate safeguard
    mechanisms for Member States to contain
    expenditure in compliance with EU competition
    rules". European Commission

22
Role of Europe in Drug Development Pricing and
Relative effectiveness
  • Historically, European payers (governments,
    insurance funds, social security systems) simply
    dismissed industry demands for higher prices
  • Industry response was to introduce patient
    benefit into the public debate
  • Prices were not simply about profits but to
    ensured that ever-better medicines would be
    developed.
  • The payers had a bit of a dilemma
  • They could not respond that they did not want
    better medicines.
  • They could not tell the people that they are
    going to get only the oldest and cheapest drugs.
  • Payers new approach
  • We want better medicines, but if we are going to
    pay for them, we have to be sure they really are
    better.
  • Industry has traditionally wanted to limit the
    criteria for product authorization to safety and
    efficacy and has so far succeeded
  • However, Industry is grave danger of losing this
    limitation in respect of pricing and
    reimbursement
  • The debate is now underway, in a serious fashion,
    of how to measure not just the efficacy but the
    relative efficacy of a new medicine.

23
Role of Europe in Drug Development Relative
effectiveness
  • The Pharmaceutical Forum
  • Relative effectiveness assessing the
    effectiveness of medicines in comparison with
    other treatment options
  • The progress report makes a series of
    recommendations on how to support Member States
    applying relative effectiveness systems in order
    to allow containment of pharmaceutical costs as
    well as a fair reward for innovation.
  • Relative effectiveness assessment systems are
    relatively new for many Member States and rather
    complex.
  • Nevertheless, the outcome of relative
    effectiveness assessments is promising as they
    will help identify the most valuable medicines,
    both in terms of clinical efficiency and
    cost-effectiveness, and will help set a fair
    price for these medicines.

24
Relative effectiveness of Osteoporosis Medications
  • Currently, fracture prevention trials are
    required for registration of medications for the
    treatment of osteoporosis.
  • For head-to-head fracture trials, the sample size
    is influenced by the expected incidence of
    fractures and other factors, including the
    analysis objective (an equivalence or
    non-inferiority trial versus a superiority
    trial).
  • Because both active treatments may reduce both
    the overall incidence of fracture and the
    difference between treatment groups, sample sizes
    will be considerably larger than in a
    placebo-controlled trial.
  • For a superiority trial Power of 80 and a
    typical fracture rate
  • To show a difference of 10 in efficacy --
    235,000 participants would be required
  • To show a difference of 30 in efficacy 18,080
    would be required
  • Even if the fracture rate in one group were 15,
    14,700 participants would be needed to
    demonstrate a difference.
  • In an equivalence trial (non-inferiority), sample
    sizes in the 30,000 to 40,000 range are required.
  • Head-to-head trials could examine endpoints that
    are well-validated surrogates for fracture
    events, such as BMD and bone turnover. These
    trials can be considerably smaller and more
    quickly completed than fracture trials, and a
    large number of studies have documented the
    strong, graded association between fracture
    incidence and these surrogates.

25
Role of Europe in Drug Development -- Proposals
  • European Federation of Pharmaceutical Industry
    Associations (EFPIA)
  • Position Paper Barriers To Innovation In The
    Development Of New Medicines In Europe And
    Possible Solutions To Address These Barriers
  • Improved dialogue with regulators during
    development and with payers prior to regulatory
    approval
  • Increased acceptance by regulatory authorities of
    biomarkers and surrogate clinical end points.
  • Increased involvement of other stakeholders such
    as patients in the regulatory review process
  • Consideration should be given to developing
    methods to collect data on risks and benefits of
    medicines once they are available in a real-world
    setting

26
Role of Europe in Drug Development -- Proposals
  • European Federation of Pharmaceutical Industry
    Associations (EFPIA)
  • Position Paper Barriers To Innovation In The
    Development Of New Medicines In Europe And
    Possible Solutions To Address These Barriers
  • Pricing and reimbursement models that reward
    innovation should be encouraged.
  • Member States should allow free pricing for
    medicines that are not reimbursed by the public
    purse.
  • Consumers should be made aware of new medicines
    and have the choice of paying for them if they
    are not reimbursed by governments.
  • Price competition in the generic sector should be
    fierce to allow savings made from the use of
    generics to be reinvested through the use of
    patented, innovative medicines.
  • Governments should explore alternative funding
    options including increasing private sources of
    funding which are compatible with principles of
    social security systems.
  • Governments should ensure that public money is
    spent on healthcare interventions that work, but
    evaluation mechanisms aimed at ensuring this must
    be independent, transparent and scientifically
    robust. This is not currently the case in many
    countries.
  • The European Commission should encourage Member
    States to view health technology assessment as a
    means to achieve better health outcomes rather
    than a means to delay or even exclude innovative
    medicines from reaching patients.
  • Dialogue between payers and companies should be
    initiated earlier allowing healthcare payers to
    establish, for example, if there are any specific
    data requirements that the payers would be
    looking for in order to reimburse a medicine.

27
Role of Europe in Drug Development -- IMI
  • The Innovative Medicines Initiative proposes
    clear practical paths to accelerate the
    development of safe and more effective medicines
    by joint public and private collaborations.
  • Aim To remove major bottlenecks in drug
    development, acting where research is the key
  • Long term objectives -- To increase
    competitiveness of European pharmaceutical sector
    and foster Europe as the most attractive place
    for pharmaceutical RD, thereby enhancing access
    to innovative medicines for patients

28
Role of Europe in Drug Development What is
being done?
  • The Seventh Framework Programme for research and
    technological development (FP7)
  • is the European Unions main instrument for
    funding research in Europe.
  • Is the result of years of consultation with the
    scientific community, research and policy making
    institutions, and other interested parties.
  • Since their launch in 1984, the Framework
    Programmes have played a lead role in
    multidisciplinary research and cooperative
    activities in Europe and beyond.

29
Conclusions
  • European-based pharmaceutical drug development
    has strong history and continues to make a major
    contribution to the European Union economics and
    public health.
  • Unfortunately, the role of Europe in Drug
    Development is rapidly weakening secondary to
    flawed financial decisions by member states.
  • Proposals and activity are taking place to begin
    to address the complex issues around the balance
    of innovation and competitiveness while ensuring
    satisfactory delivery of public health .
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