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Pharm Science,technology and public health

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Such realities inevitably influence the balance of democratic' debate ... Health technology assessment, and the politics of weighing tangible short term ... – PowerPoint PPT presentation

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Title: Pharm Science,technology and public health


1

The Politics of Biopharma Neo-corporatism or
networks? International Workshop on Political
Science and Health Policy Analysis Madrid 17th
November 2008
David Taylor Professor of Pharmaceutical and
Public Health Policy, The School of Pharmacy,
University of London
2
This presentation
This contribution discusses issues relating to
public policy on pharmaceutical pricing and
spending, access, safety and innovation The
question neo-corporatism or networks? is taken
here to relate to the extent to which European
decision making in these fields is either
dominated by sectional industrial and linked
governmental interests, or is the result of more
balanced interactions between a full range of
stakeholders within governmentally facilitated
fora
3
It is argued that policy formation processes
relating to the pharmaceutical sector have not
in overall terms been distorted by
neo-corporatist interventions in the ways that
critics (such as, for example, Marcia Angell and
John Abraham) have on occasions implied. Failures
to involve the full range of stakeholders in
pharmaceutical sector policy in adequately
informed debate relate in part to the inherent
complexity of, and levels of uncertainty relating
to, the issues involved.
4
Pharmaceutical sector stakeholders
  • Pharmacy as a European profession dates back
    around 1000 years. It originated from the need to
    risk manage and quality assure medicines
    manufacturing, prescribing and use
  • The research based pharmaceutical industry is
    less than 100 years old. It grew out pharmacy and
    pharmaceutical product trading, and is centrally
    concerned with managing both financial and
    clinical risk taking in the pursuit of
    therapeutic innovation
  • Other stakeholders in the modern pharmaceutical
    sector include local and national communities and
    the various patient groups within them, together
    with
  • politicians and associated institutions and
    groups
  • professions such as medicine and nursing
  • health service funders
  • health service provider managers
  • academic institutions and research communities
  • the media

5
Context 1. Structural trends
  • Since the start of the 1950s health spending in
    Europe has increased to around 10 per cent of
    GDP. Of this total, medicine costs typically
    account for a highly visible 10-20 per cent
  • Pharmaceutical research costs continue to rise,
    but the number and potential volume use of
    marketed innovations appears to be falling
  • Pharmaceutical research costs are broadly
    balanced by promotional spending in Europe
  • There are significant variations in research
    capacity between European Member States, and in
    their medicine price control schemes. This has
    led to extensive pharmaceutical parallel trading
    in the European single market
  • Overall spending on medicines is critically
    influenced by the mix of patented and
    non-patented medicines employed, and the degree
    to which the use of non-branded generic medicines
    supplied at (near) commodity prices is
    incentivised.

6
Context 2. Policy issues
  • Promotional and information provision regulation
  • Pricing and reimbursement policies
  • Parallel trading
  • Patient payments
  • Intellectual property protection and research
    incentivisation
  • Medicinal product licensing
  • Therapeutic risk management
  • Access to new and older treatments in both rich
    and poor world countries

Agenda setting is driven by industrial,
professional and political/pressure group activity
7
Context 3. Stages of health development
  • Demographic transition (Warren Thompson, 1929)
  • Epidemiological transition (Abdel Omran, 1972)
  • Care transition, and the changing role of the
    state

King James 1 granting the British Apothecaries
their first Royal Charter in 1617
8
Context 4. Dimensions of later stage care
transition
  • Increasingly assertive consumerism in health care
    greater demands for both personal autonomy and
    medicines safety and effectiveness, even in
    extreme circumstances
  • Decreased tolerance of gross health inequalities,
    and higher expectations of universal care access
  • Decreased social distance between health
    professionals and service users, and increased
    role blurring
  • (Re)recognition of the role of self care in
    public health improvement
  • A shift of aspects of care quality protection
    from professional to regulatory agency and
    managerial control

For sources see, for instance, the work of
Inglehart, Giddens, Sennet, Flynn and Salter
9
Per capita spending on pharmaceuticals, 2005, USD
PPP (1)
Source for Figures 1-6 Pharmaceutical pricing in
a global market, OECD, 2008
10
Pharmaceutical spending in total health spending
(2)
11
Increases in pharma and health spending,
1997-2005 (3)
12
Retail price levels for medicines, 2005 (4)
13
Pharmaceutical retail price components (5)
14
Trade balances, 2003 (6)
15
EU countries with a successful pharmaceutical
(industry) research sector tend to favour low
generic medicine supply costs, and relatively
high patented product prices. Those with a less
successful research record tend to allow higher
off patent medicine prices and lower patented
product returns However, parallel trading to a
degree complicates the picture in relation to
actual national spending on innovative products
16
The medicines pricing, spending and profitability
debate
  • Professional attitudes have played a critically
    important part in determining the varying usage
    of low cost generic medicines in differing EU
    Member States
  • Contrasting social attitudes in Europe and the US
    have played a key part in determining the balance
    between ability to pay focused approaches to
    health care provision on the one hand, and public
    health oriented solutions on the other. Such
    factors have in turn influenced pharmaceutical
    pricing strategies
  • Political interests influence critically the
    policy balance between immediate employment
    protection, care provision and tax/cost reduction
    objectives on the one hand, and long term human
    welfare and knowledge gains on the other
  • Private (and public) investors needs to
    counterbalance high levels of risk taking with
    supra-normal levels of potential profitability
    are not easily understood. Such realities
    inevitably influence the balance of democratic
    debate

17
Parallel trading, patents and human welfare
  • Recent US debate on the desirability or not of
    drug re-importation from Europe (that is,
    allowing one way parallel importing of
    medicines at low regulated European Member State
    prices into America) highlights the complexity of
    the political debate surrounding pharmaceutical
    intellectual property rights and the funding of
    private sector research.
  • Within Europe, disputes relating to medicines
    parallel trading have vividly illustrated
    tensions between short and long term public (and
    national) interests. So too does the
    international policy debate on issues such as
    patent protection

Byron Dorgan and Olympia Snowe
18
  • Within Europe, disputes relating to medicines
    parallel trading vividly illustrate tensions
    between short and long term public (and national)
    interests.
  • So too does the international policy debate on
    the social benefits of patent protection. The
    case of Glivec in India revealed some of the
    political and social dilemmas that exist in this
    context

Armatya Sen
19
Medicines licensing and safety (1)
  • In the United Kingdom the House of Commons Select
    Committee on Health published in 2005 a report
    entitled The Influence of the Pharmaceutical
    Industry. In part on the basis of previously
    published academic research it argued that the
    consequence of lax oversight is that the
    industrys influence has expanded and a number of
    practices have developed which act against the
    public interest.
  • The Select Committee advocated moves away from
    collaborative models of regulation towards a
    greater separation between the pharmaceutical
    industry and the public agencies charged with its
    oversight.

20
Medicines licensing and safety (2)
In 2002 Abraham and Davis hypothesised that the
passage into American law of the Prescription
Drug User Fee Act of 1992 (the PDUFA, which was
intended by its originators to accelerate the
process of US drug licensing and reduce the time
lag between beneficial new medicines being made
available to the American as opposed to the UK/EU
population) would increase the rate of medicine
safety withdrawals in the United States. The
implied outcome of such a trend would be
avoidable harm to the US publics health. This
might partly be a result of regulatory capture,
associated with the FDA becoming reliant on fees
paid by pharmaceutical companies for the
licensing of medicines.
21
Medicines licensing and safety (3)
  • At the School of Pharmacy we attempted to test
    the hypothesis that the introduction of the US
    Prescription Drug User Fee Act would increase the
    number of medicine withdrawals on safety grounds
    in the US as compared with the UK in the period
    1995-2005
  • This self funded research was not published. But
    on the basis of the evidence available to the end
    of 2005 (and notwithstanding the withdrawal of
    Vioxx in 2004) we concluded that it could not be
    shown that lax medicines regulation was
    responsible for significant levels of harm to the
    publics health in either the US or the UK during
    the previous decade.
  • We argued that the stakeholders in relevant
    health policy fields may have paid too little
    attention to public interests in managing
    therapeutic risks more effectively, in order to
    allow people with inadequately treated conditions
    access to a wider range of possibly effective
    but also potentially hazardous treatments.
  • For the purposes of this contribution this work
    suggests that in the biopharma policy context
    desirable developments are not being inhibited by
    restrictive neo-corporatist influences. Rather,
    there appear to be inherent barriers to involving
    members of the wider stakeholder network in an
    adequately informed debate

22
Other issues for European health and wealth
creation an agenda for research?
  • Globalisation, and the growing competitive
    advantages of China and India
  • Promotional and information regulation, and the
    balance between patient protection and service
    user empowerment
  • Health technology assessment, and the politics of
    weighing tangible short term individual patient
    benefit against projected long term community
    progress

23
Conclusions
  • The main messages of this contribution are that
  • The politics of biopharma is often complicated
    and conflicted because of the complex nature of
    the competing opportunities being addressed. This
    can make supporting informed and inclusive policy
    formation processes highly problematic
  • It is not clear if and to what extent relevant
    resource allocation and regulatory decision
    making processes can in practice be further
    improved in Europe or elsewhere. But is
    reasonable to hope that the application of
    political science based insights could help to
    widen the circle of stakeholders able to take
    part in informed debate about pharmaceutical
    science and business related policy
  • Failures to take the most constructive possible
    approaches to fostering the application of
    biopharmaceutical science and its applications
    will impose heavy costs on not only the European
    population, but humanity globally

24
david.taylor_at_pharmacy.ac.uk
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