International Committee of the Red Cross, Centre for Governance of Knowledge and Development, RegNet

1
International Committee of the Red Cross, Centre
for Governance of Knowledge and Development,
RegNet, National Institute of Health and Human
Sciences, Australian and New Zealand Institute of
Health Law and EthicsInternational Humanitarian
Law and Access to Essential Medicines

• Dr Thomas Faunce BA/LLB(Hons) B Med PhD
• Senior Lecturer Medical School and Law Faculty
• Project Director, Globalization and Health
  Project, Centre for Governance of Knowledge and
  Development, RegNet, Australian National
  University

2
Content

• Discusses the extent to which International
  Humanitarian Law and evolving conceptions of
  Crimes Against Humanity may provide a rational
  limit to the global expansion and adverse public
  health consequences of intellectual property
  protection over innovative pharmaceuticals at a
  time when a large proportion of the worlds
  population is involved in armed conflict

3
International Humanitarian Law

• Geneva Conventions 1949
• Protection of Wounded and Sick Armed Forces
  members in the Field (Convention I) at Sea
  (Convention II) and when Prisoners of War
  (Convention III)
• Protection of Civilians (Convention IV)
• Additional Protocol I Protecting Victims of
  International Armed Conflicts (1977)
  
• Additional Protocol II Protecting Victims of
  Non-International Armed Conflicts (1977)
  
• Geneva Conventions Act 1957 (Cth)

4
International Humanitarian Law Evolving

• The nature of the norms forming part of
  humanitarian law is not static. It continually
  evolves under the pressure of changes both in
  general international lawand in the conduct of
  warfareThe demise of the traditional conception
  that a states rights over its own nationals are
  absolute opened the door, albeit slightly, to the
  idea of valid claims by individuals against a
  hostile state during an armed conflict. Such
  claims are different in nature from the
  traditional humanitarian approach to the
  protection of individuals, which relied more on
  means related to diplomatic protection through
  the offices of protecting powers
• Rene Provost, International Human Rights and
  Humanitarian Law Cambridge Uni Press, Camb.
  (2002) 53-54.

5
IHL and Individual Responsibility

• Unlike International human rights law individual
  responsibility has long been a central tenet of
  international humanitarian law
  
• A State is responsible under IHL for acts of its
  armed forces and, more generally of its agents
  
• Geneva Convention IV 1949, article 29
• Protocol I 1977, article 91.

6
International Criminal Court

• Rome Treaty of 17 July 1998 establishing the
  International Criminal Court
  
• Art 21 The Court shall apply
• (a) in the first place, this Statute, Elements of
  Crimes and its Rules of Procedure and Evidence
  
• (b) In the second place, where appropriate,
  applicable treaties and rules of international
  law, including the established principles of the
  international law of armed conflict.

7
Essential Medicines and the Global Burden of
Illness

• Today over one-third of the world's population
  still lacks access to essential drugs in the
  poorest parts of Africa and Asia  Over 50 lack
  access to essential drugs. 50 to 90 of drugs in
  developing and transitional economies are paid
  for out-of-pocket. The burden falls heaviest on
  the poor, who are not adequately protected by
  current policies. Less than 1 in 3 developing
  countries have fully functioning drug regulatory
  authorities. 10 to 20 of sampled drugs fail
  quality control tests in many developing
  countries. Failure in good manufacturing
  practices too often results in toxic, sometimes
  lethal, products 

8
Essential Medicines and the Global Burden of
Illness

• In 2005, there will be over 40 million deaths in
  developing countries, one-third among children
  under age five.
  
• Ten million will be due to acute respiratory
  infections, diarrhoeal diseases, tuberculosis,
  and malaria -- all conditions for which safe,
  inexpensive, essential drugs can be life-saving.
• Simple iron-folate preparations can reduce
  maternal and child mortality from anaemia of
  pregnancy
  
• Treatment of sexually transmitted diseases
  reduces transmission of the AIDS virus and
  treatment of hypertension reduces heart attacks
  and strokes.
• Without treatment, the 28 million people living
  with HIV/AIDS (PLWAs) on the African continent
  today will die predictable and avoidable deaths
  over the next decade.
• More than 2 million died of HIV/AIDS in Africa in
  2004, most without access to any medication.
  

9
Millennium Indicators

• The Millennium Indicators Database shows the
  latest available data as of April 2005. Goals,
  targets and indicators
  
• A framework of 8 goals, 18 targets and 48
  indicators to measure progress towards the
  Millennium Development goals was adopted by a
  consensus of experts from the United Nations
  Secretariat and IMF, OECD and the World Bank.
• Target 17.In cooperation with pharmaceutical
  companies, provide access to affordable essential
  drugs in developing countries
  
• Indicators46. Proportion of population with
  access to affordable essential drugs on a
  sustainable basis (WHO)
  
• Result of search no data available

10
Geneva Convention IV

• Article 23 Each contracting party shall allow
  the free passage of all consignments of medical
  and hospital storesintended only for civilians
  of another High Contracting Party, even if the
  latter is its adversary. It shall likewise permit
  the free passage of all consignments of essential
  foodstuffs, clothing and tonics intended for
  children under 15, expectant mothers and
  maternity cases.

11
IHL and Children

• Article 77 in Protocol I and in Article 4 in
  Protocol II state that children shall be the
  object of special respect  and  children shall
  be provided with the care and aid they require.
• Fourth Convention, Articles 23, 50, 81, 89 and 91
  and Protocol I, Article 70- children have the
  right to receive care and aid by the dispatch of
  medicines, foodstuffs, and clothing

12
What Are Essential Medicines?

• The WHO List of Essential Drugs are those that
  satisfy the basic health care needs of the
  majority of the civilian population
  
• They should therefore be available at all times
  in adequate amounts and in the appropriate dosage
  forms, and at a price that individuals and the
  community can afford.
• This obligation flows from IHL in relation to
  countries involved in armed conflict and from the
  Right to Health in article 12 of the ICESCR under
  international human rights law

13
Criteria for Essential Medicine Listing

• 4) International Nonproprietary Name (INN,
  generic name) of the medicine 5) Whether listing
  is requested as an individual medicine or as an
  example of a therapeutic group 6) Information
  supporting the public health relevance
  (epidemiological information on disease burden,
  assessment of current use, target population) 7)
  Treatment details (dosage regimen, duration
  reference to existing WHO and other clinical
  guidelines need for special diagnostic or
  treatment facilities and skills)
• 8) Summary of comparative effectiveness in a
  variety of clinical settings
  
• Identification of clinical evidence (search
  strategy, systematic reviews identified, reasons
  for selection/exclusion of particular data),
  Summary of available data (appraisal of quality,
  outcome measures, summary of results), Summary of
  available estimates of comparative effectiveness.
  Information on cost and cost-effectiveness should
  preferably refer to average generic world market
  prices as listed in the International Drug Price
  Indicator Guide, an essential medicines pricing
  service provided by WHO and maintained by
  Management Sciences for Health. If this
  information is not available, other international
  sources, such as the WHO, UNICEF and Médecins
  sans Frontières price information service, can be
  used. All cost analyses should specify the source
  of the price information
• 9) Summary of comparative evidence on safety
  Estimate of total patient exposure to date,
  Description of adverse effects/reactions,
  Identification of variation in safety due to
  health systems and patient factors, Summary of
  comparative safety against comparators

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Criteria for Essential Medicine Listing

• 10) Summary of available data on comparative cost
  and cost-effectiveness within the pharmacological
  class or therapeutic group range of costs of the
  proposed medicine, comparative cost-effectiveness
  presented as range of cost per routine outcome
  (e.g. cost per case, cost per cure, cost per
  month of treatment, cost per case prevented, cost
  per clinical event prevented, or, if possible and
  relevant, cost per quality-adjusted life year
  gained)
• 11) Summary of regulatory status of the medicine
  (in country of origin, and preferably in other
  countries as well)
  
• 12) Availability of pharmacopoieal standards
  (British Pharmacopoeia, International
  Pharmacopoiea, United States Pharmacopoeia)
  
• 13) Proposed (new/adapted) text for the WHO Model
  Formulary
  

15
Cost-Effectiveness Evaluation Central to Who
Essential Medicines List

• First report of the Expert Committee on the
  Selection of Essential Drugs in 1977
  
• Model List revised and updated in ten further
  reports
  
• By 1998 140 countries had developed their own
  national lists of essential drugs, often applying
  the concept to teaching hospitals and facilities
  providing specialized care, health insurance
  schemes, and regulatory agencies involved with
  rationalization of drug supply and donation
• Scientific Cost-Effectiveness evaluation (similar
  to that performed by the Australian PBAC) is
  central to the international WHO and national,
  essential medicines project

16
Spread of Cost-Effectiveness Pricing

• Although originally intended for developing
  countries, an increasing number of developed
  countries also use key components of the WHO
  essential drugs concept, in particular
  cost-effectiveness pricing.
• This development has been triggered by new
  medicine costs increasing disproportionately with
  pharmaceutical industry profits or proven
  community benefit, aggressive direct-to-consumer
  marketing of expensive innovative drugs and by
  marked variations in the access to quality health
  care created by privatization initiatives.

17
Pharmaceutical Innovation

• To sustain a (minimally acceptable) 15 annual
  growth rate, a multinational pharmaceutical
  company needs to discover 8-9 new molecular
  entities (NMEs) each year (10 growth rate needs
  5-6 NMEs and 5 growth rate 2-3NMEs)
• Current industry average is 0.5 NMEs per year
• (1)Evergreening of brand name blockbuster
  patents, (2) redefining innovation as
  incremental and (3) dismantling
  cost-effectiveness pricing mechanisms, provide
  alternatives that sustain profits, but at a
  global public health detriment

18
Global Intellectual Property Protection over
Innovative Pharmaceuticals

• 1994 multilateral Trade-Related Intellectual
  Property (TRIPS) Agreement
  
• Bilateral Free Trade Agreements containing
  alleged TRIPS-Plus intellectual property
  provisions
  
• US Trade Representative (USTR) Special 301
  Priority Watch List

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Patents and Essential Medicines List

• Attaran checked the patent status of all
  medicines on the Model List in 65 low-and
  middle-income countries. He concluded that only
  17 medicines on thelist are patentable, although
  usually they are not actually patented,and that
  overall patent incidence is only 1.4. This
  leaves 98 ofmedicines on the Model List
  off-patent in 65 low- and middle income
  countries.
• BUT
• (1) Since 2002 patent status and costs are no
  longer a selection criteria the main
  considerations are now safety and public health
  value and comparative cost-effectiveness within a
  therapeutic group. Examples of recently included
  medicines are azythromycin and antiretroviral
  medicines (ARVs)
• (2)Global patents do not exist most patents are
  national and some are regional.
  
• (3) Patents may have expired since medicines
  listed on Model List, or may not have been
  patented because there no patent protection was
  available

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Patents and Essential Medicines

• (4) The assumption that all patents in all
  countries in the study are of equaleconomic
  importance is wrong. If patents exist in only 2
  countries out of100, but these 2 are large
  producing countries, patents would certainlybe a
  barrier to access.(5) Counting the number of
  countries with registered patents as
  astatistical exercise is also misleading from a
  public health point ofview. Countries are
  different in size and have different
  diseasesburdens. For example, a patent on ARVs
  in South Africa has much morepublic health
  impact then one in a small country or one with
  fewHIV/AIDS patients. (6) Not all medicines on
  the Model List are of equal medicalimportance.
  The Brazilian National AIDS Programme has 14 ARV
  medicines, but 3 patented products account for
  63 of the total programme expenditure. Finally,
  a patent on one medicinemay also reduce access
  to an important treatment, as in the case
  offixed dose combinations.

21
TRIPS Agreement

• Convention on Trade Related Intellectual Property
  Rights
  
• An initiative of Industry CEOs, including US
  PhRMA
  
• Uses trade sanctions to enforce higher
  intellectual property standards
  
• Exceptions created by Doha declaration on TRIPS
  and Public Health circumvented by US bilateral
  trade deals using Article 4 MFN
  
• NVNB claims permitted by Article 64

22
Least Developed Countries in Armed Conflict
Situations That Have Signed the TRIPS Agreement

• Angola, Bangladesh, BeninBurkina Faso Border
  regions at war
  
• Burundi Occupied by UN troops - several armed
  rebel groups (primarily ethnic Hutus) still
  contend with government forces CambodiaCentral
  African Republic recent violent coup- several
  incidents of violence between mercenaries and
  domestic population, cross-border fighting with
  several nations
• ChadOngoing civil war - spillover violence from
  neighboring Sudan in border areas Congo
  (Brazzaville) - Ongoing low-level civil war -
  several armed insurgency groups - spillover
  violence from conflict in DR Congo
• Congo, DR (Kinshasa) - Occupied by UN troops -
  incursions by militaries from neighboring
  countries, particular Rwanda and Uganda -
  widespread civil war, insurgencies, domestic
  unrest and inter-ethnic fighting
• DjiboutiGambia Generally peaceful but has seen
  sporadic violence along political lines
  GuineaPolitical instability - some inter-ethnic
  violence - large numbers of refugees from
  neighboring countries Guinea BissauHaiti
  Recently uffered coup - occupied by UN troops -
  regular incidents of domestic unrest and violence
  
• Lesotho, Madagascar, Malawi, Maldives, Mali.

23
Least Developed Countries in Armed Conflict
Situations That Have Signed the TRIPS Agreement

• MauritaniaSuffered coup in 2003 and attempted
  coups in 2004 - remants of human slave trade
  still exist Mozambique, MyanmarNepalOngoing
  civil war between Marxist insurgents and gov't
  forces Niger Numerous civil insurgencies and
  violent inter-ethnic conflicts - widespread
  inter-ethnic and inter-religious civil unrest
• Rwanda Involved in armed conflicts ongoing in DR
  Congo - widespread inter-ethnic unrest
  SenegalHas troops in DR Congo, Liberia and
  Kosovo - ongoing but fading civil war in the
  south - numerous incidents of inter-ethnic
  violence and unrest Sierra Leone Occupied by UN
  and ECOWAS troops - is just now recovering from
  civil war - political situation is extremely
  fragile Solomon Islands Occupied by Australian
  troops - widespread inter-ethnic unrest
  TanzaniaTogoUgandaArmed insurgency in north -
  has troops and/or militias involved in conflicts
  in Sudan and DR Congo Zambia
• LDCs in the process of accession to the WTO
  Bhutan, Cape Verde, Ethiopia (Continued
  skirmishes with Eritrea - regular occurrences of
  inter-ethnic violence esp amongst refugees ),
  Laos (Frequent occurrences of domestic terrorism
  esp. in capital (Vientiane)), Samoa, Sudan(At
  least three ongoing civil wars, esp in Darfur -
  very frequent inter-ethnic and inter-religious
  violence ), Vanuatu and Yemen. Equatorial Guinea
  and Sao Tome Principe are WTO Observers.

24
Developing Countries and TRIPS

• Developing countries that are not least-developed
  countries had to apply the TRIPS Agreements
  provisions by 1 January 2000. In 2000 and 2001,
  the TRIPS Council reviewed the legislation of the
  following members whose transition periods
  expired on 31 December 1999
• Antigua and Barbuda, Argentina, Bahrain,
  Barbados, Belize, Bolivia, Botswana, Brazil,
  Brunei Darussalam, Cameroon, Chile, Colombia,
  Congo, Costa Rica, Côte dIvoire, Cuba, Cyprus,
  Dominica, Dominican Republic, Egypt, El Salvador,
  Estonia, Fiji, Gabon, Ghana, Grenada, Guatemala,
  Guyana, Honduras, Hong Kong, China, India,
  Indonesia, Israel, Jamaica, Kenya, Korea, Kuwait,
  Macau, Malaysia, Malta, Mauritius, Mexico,
  Morocco, Namibia, Nicaragua, Nigeria, Pakistan,
  Papua New Guinea, Paraguay, Peru, Philippines,
  Poland (areas which were not reviewed in
  9698), Qatar, Saint Lucia, Singapore, Sri
  Lanka, St. Kitts and Nevis, St. Vincent and
  Grenadines, Suriname, Swaziland, Thailand,
  Trinidad and Tobago, Tunisia, Turkey, United Arab
  Emirates, Uruguay, Venezuela, Zimbabwe

25
USTR Special 301 Trade Watch List

• The Trade Act of 1974 instructed the Office of
  the US Trade Representative to identify annually
  those countries that deny adequate and effective
  protection for IPR or deny fair and equitable
  market access for persons that rely on
  intellectual property protection. Section 182 is
  commonly referred to as the ''Special 301''
  provision of the Trade Act. Countries are placed
  into a hierarchy of categories, with the ranking
  of Priority Foreign Country reserved for the
  worst situations (1) Priority Foreign Country
  (2) Priority Watch List or (3) Watch List.
• Countries identified as Priority Foreign
  Countries can be subjected to a Section 301
  investigation and face the possible threat of
  trade sanctions.
• Corporations could petition the USTR to
  investigate and, ultimately, threaten trade
  sanctions against a particular unjustifiable,
  unreasonable or discriminatory policy or practice
  of a foreign country so listed.

26
Trade Watch List

• In 2005 fourteen countries were on the Priority
  Watch List Argentina, Brazil, China, Egypt,
  India, Indonesia, Israel, Kuwait, Lebanon,
  Pakistan, the Philippines, Russia, Turkey, and
  Venezuela.
• Thirty-six are on the Watch List, meriting
  bilateral attention to address the underlying IPR
  problems Azerbaijan, Bahamas, Belarus, Belize,
  Bolivia, Bulgaria, Canada, Chile, Colombia, Costa
  Rica, Croatia, Dominican Republic, Ecuador,
  European Union, Guatemala, Hungary, Italy,
  Jamaica, Kazakhstan, Korea, Latvia, Lithuania,
  Malaysia, Mexico, Peru, Poland, Romania, Saudi
  Arabia, Slovakia, Taiwan, Tajikistan, Thailand,
  Turkmenistan, Uruguay, Uzbekistan, and Vietnam.
• This year's Special 301 Report also announced
  OCRs for the following seven countries Ukraine,
  Russia, Philippines, Indonesia, Canada, the
  European Union and Saudi Arabia.

27
PhRMA and Brazil

• In 1987, PhRMA demanded trade retaliation against
  Brazil under section 301, for the latters lack
  of adequate patent protection for US
  pharmaceuticals.
• When Brazil refused on social justice grounds to
  alter its policy, the US placed a large
  retaliatory tariff on imports of Brazilian
  pharmaceuticals.
• Brazil filed a complaint with the General
  Agreement on Tariffs and Trade (GATT), but
  withdrew this when US sanctions were dropped in
  return from a Brazilian commitment to increased
  pharmaceutical patent protection.(Mossinghoff
  1991)
• G Mossinghoff, For Better International
  Protection (1991) 26 Les Nouvelles 75-79.
  

28
2004 Trade Watch List

• The 2004 Special 301 Report Watch List will
  probably remain a classic example of public law
  at the service of private corporations. (Drahos
  and Braithwaite 2002)
• Canada systemic inadequacies in Canadian
  administrative and judicial procedures continue
  to allow the early and often infringing entry of
  generic versions of patented medicines into the
  marketplace.
• Croatia lack of co-ordination between the
  patent and health authorities to prevent patent
  infringement by the grant of marketing approval
  for copycat pharmaceuticals, and failure to
  provide expeditious and timely judicial remedies
  to parties seeking to stop infringing
  activities.
• Ecuador the number of copy products granted
  marketing approval by the health authority
  continues to increase, due to the lack of any
  linkage system between the health and patent
  agencies.
• Italy its policies may adversely affect the
  prior practice of patent term extension for
  pharmaceuticals.
  
• Malaysia denigrated for failing to link
  pharmaceutical products the marketing approval
  process to the patent registration process.
  
• Poland is criticised for permitting the
  commercial availability of generic versions of
  patent protected pharmaceutical products.
  
• Vietnam is castigated because counterfeit
  pharmaceuticals are common in the marketplace.
  

29
South African HIV/AIDS Litigation

• In 1997 South African Medicines and Related
  Substances Control Amendment Act. Section 15C
  expanded the conditions for compulsory licenses
  and parallel importation to facilitate the
  capacity of more poor South African citizens
  gaining access to cheap anti-HIV/AIDS
  pharmaceuticals.
• PhRMA succeeded in placing South Africa on the
  USTR Priority Watch. PhRMA lobbied the US
  government to take stronger action (WTO Dispute
  Settlement Body).
• In 1998, 41 pharmaceutical companies commenced
  litigation, President Nelson Mandela was named as
  first defendant.

30
Doha Declaration

• November 2001, WTO Ministers issued a separate
  Declaration on the TRIPS Agreement and Public
  Health.
  
• Paragraph 6 of this equity clarification
  permitted WTO Members with insufficient or no
  manufacturing capacities in the pharmaceutical
  sector to issue compulsory licenses for the
  production, or importation, of cheap essential
  medicines without consent from the patent holder,
  

31
Doha Declaration

• After a further WTO decision of 30 August 2003,
  Members could unequivocally waive article 31(f)
  of TRIPS and respond to compulsory licenses to
  export to markets other than domestic ones where
  that other country does not have the capacity to
  manufacture medicines itself.
• Not restricted to situations of national
  emergency of extreme urgency.
  
• The Ministerial Declaration stressed the
  importance of implementing and interpreting
  TRIPS in a manner supportive of public health,
  by promoting both access to existing medicines
  and research and development into new
  medicines.
• As of 2005, no developed countries had responded
• World Trade Organization, Declaration on the
  TRIPS Agreement and Public Health (WT/MIN
  (01)/DEC/2)
  
• World Trade Organisation, Ministerial
  Declaration, Doha (WT/MIN (01)/DEC/1)
  

32
US Study of Reference Pricing Systems in OECD
Countries

• US Dept Commerce
• Commissioned by Medicare Prescription Drug
  Improvement and Modernisation Act (2003)
  
• Includes France, Germany, UK, Greece,
  Switzerland, Japan, Canada, Australia
  
• Plan to dismantle reference pricing systems in
  these countries and make their medicines prices
  move to higher US benchmark
  
• Endorsed by Medicines Australia in its submission
  to Productivity Commission of Impact of Medical
  Technologies

33
AUSFTA and Pharmaceutical Pricing

• The Australian-United States Free Trade
  Agreement(AUSFTA) entered into force 1 January
  2004
  
• First such bilateral US Trade Deal (Bahrain,
  Chile, Singapore, Morocco, Jordan, and the
  signatories to the Central America Free Trade
  Agreement (Dominican Republic, Costa Rica, El
  Salvador, Guatemala, Honduras, and Nicaragua) to
  include specific provisions on a developed
  nations pharmaceutical cost-effectiveness
  pricing system
• Such systems are a significant part of global
  public health regulation (WHO Essential Medicines
  List) and their continuance is important to IHL
  obligations

34
US Trade Negotiators Legislated Obligation

• To Seek the Elimination of Pharmaceutical
  Reference Pricing Systems
  
• Medicare Prescription Drug Improvement and
  Modernization Act 2003 21 U.S.C conference
  agreement
  
• Trade Act 2002 (US), 107-210 2102 (b) (8) (D).

35

• AUSFTA, Annex 2C on Pharmaceuticals.
• Interpretive Principles
• The Parties are committed to facilitating high
  quality health care and continued improvements in
  public health for their nationals. In pursuing
  these objectives, the Parties are committed to
  the following principles
• a)the important role played by innovative
  pharmaceutical products in delivering high
  quality health care
  
• b)the importance of research and development in
  the pharmaceutical industry and of appropriate
  government support, including through
  intellectual property protection and other
  policies

36

• c)the need to promote timely and affordable
  access to innovative pharmaceuticals through
  transparent, expeditious, and accountable
  procedures, without impeding a Partys ability to
  apply appropriate standards of quality, safety,
  and efficacy and
• d) The need to recognize the value of innovative
  pharmaceuticals through the operation of
  competitive markets or by adopting or maintaining
  procedures that appropriately value the
  objectively demonstrated therapeutic significance
  of a pharmaceutical

37
Other Key AUSFTA PBS Provisions

• Article 17.10.4 Marketing approval by TGA of
  Generic Drug must be prevented when any type of
  patent is claimed by a brand-name manufacturer
  (evergreening)
• Article 21.2(c) Non Violation Nullification of
  Benefits (applies to Annex 2C and Ch 17)

38
PBS is Based on Medicine Cost Effectiveness and
Generics

• Section 101 (3A-3C) of National Health Act 1958
  (Cth) requires PBAC to base recommendation on
  the effectiveness and cost of therapy involving
  the use of the drug, preparation or class,
  including by comparing the effectiveness and cost
  of that therapy with that of alternative
  therapies, whether or not involving the use of
  other drugs or preparationsif substantially
  more costly..shall not recommend
• unlessprovides a significant improvement in
  efficacy or reduction of toxicity over the
  alternative therapy or therapies

39
PBS Cost-Effectiveness

• Submission specifies a disease (and relevant
  subsets involving patient characteristics) and a
  listing price based on assessment of the best
  relevant available data on clinical effect
  against the comparitor (generally the drug most
  prescribed on the PBS for the same indication,
  but may be the standard medical (non-drug)
  treatment.
• Pharmaceutical companies prefer no comparisons or
  against the most expensive drug with the best
  head to head data
  
• Expert reviewers consider the cost and
  effectiveness of the product against comparative
  substances in the relevant therapeutic class and
  create simulations to assess the incremental cost
  effective ratio (the additional cost for an
  additional beneficial effect, or Quality of Life
  Years (QALY) gained).
• Reports reviewed by the PBAC along with an
  industry response to the experts reports and the
  summary from the Economic Sub-Committee. The
  process follows guidelines set out on the PBS
  website.
• DJ Birkett, AS Mitchell, P McManus, A
  Cost-Effectiveness Approach to Drug Subsidy and
  Pricing in Australia (2001) 20 (3) Health
  Affairs 104-114

40
Australia and AUSFTA NVNB Claim

• Australia can also mount a NVNB claim under
  article 21.2 (c) on the basis that continuance of
  cost-effectiveness pricing was a benefit we
  reasonably expected
• Need to establish that these PBS claims are a
  measure nullifying or impairing our benefit
  (Inchon Airport case)
  
• Benefits of either side are not clear under Annex
  2C
  
• New 26C of TGAbrand name manufacturer must lodge
  certificate if contesting generic entry
  

41
ICC and Crimes Against Humanity

• Article 7(1) For the purpose of this Statute,
  Crimes against humanity means any of the
  following acts when committed as part of a
  widespread or systematic attack directed against
  any civilian population with knowledge of the
  attack(b) extermination
• 7(2) extermination includes the intentional
  infliction of conditions of life, inter alia the
  deprivation of access to food and medicine,
  calculated to bring about the destruction of part
  of a population.
• Embargoes and sieges clearly contemplated
• Single, isolated, dispersed or random acts cannot
  be included
  
• attack need not involve military forces or
  violence

42
ICC and Crimes Against Humanity

• (1) preserving national sovereignty
• (2) adhering to the dictates of public
  conscience
  
• (3) ensuring legal precision
• Most delegates where convinced that no nexus of
  the atrocity campaigned against a civilian
  population to armed conflict was required (though
  Nuremberg and Tokyo Charters and ICTY Statute had)

43
Mens Rea and Crimes Against Humanity

• Article 25 (1) The Court shall have jurisdiction
  over natural persons pursuant to this statute.
  
• French proposal to include private for profit
  corporations (via leading member in control who
  committed act on behalf of and with consent of
  corporation in the course of its activities)
  unsuccessful
• But CEO and Board members of a corporation could
  be personally responsible, if overseeing policies
  that constituted a crime against humanity
  
• To commit the underlying offence the perpetrator
  must know of the broader context in which his act
  occurssuch knowledge can factually be implied
  from the circumstances.
• Tadic Judgment, Trial Chamber of the ICTY

44
The Article 98 Problem

• The Court may not proceed with a request for
  surrender or assistance which would require the
  requested State to act inconsistently with its
  obligations under
• (1) international law with respect to the State
  or diplomatic immunity of a person or property of
  a third State or
  
• (2) international agreements pursuant to which
  the consent of a sending State is required to
  surrender a person of that State to the Court
  
• Unless the Court can first obtain the cooperation
  of that third State for the waiver of the
  immunity.

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Conclusion

• Increasing intellectual property protection over
  innovative pharmaceuticals is creating a global
  public health crisis
  
• The absolute limits of such IP expansion may be
  set by international humanitarian law and by
  international law crimes against humanity
  
• Cost-effectiveness pricing is a crucial WHO
  component of providing medicines to civilians
  involved in situations of armed conflict and in
  developing countries generally
• IP protectionism should not be permitted to
  expand without limit through multilateral and
  bilateral trade agreements without interacting
  with norms from international humanitarian law
  and the international human right to health.