stop stock-outs! access to medicines for all! anti-counterfeiting initiatives and

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Stop Stock-outs!Access to Medicines for All!anti-counterfeiting initiatives and

other access barriersChrista Cepuch

OSI AEM Initiative – CS Role and Response09 December 2009, Lusaka

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Outline WHO essential medicines concept Medicines access and stock-outs / low availability in

Africa What are the barriers to access?

The journey of a pill: R&D Intellectual Property Regulation

Generics vs counterfeits vs substandard medicines Addressing initiatives which may affect stock-outs /

low availability… anti-counterfeiting initiatives

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What are essential medicines?

satisfy the priority health care needs of the population selected with due regard to public health relevance,

evidence on efficacy and safety, and comparative cost-effectiveness

intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford

implementation of the concept of essential medicines is intended to be flexible

exactly which medicines are regarded as essential remains a national responsibility

www.who.int/medicines

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Availability of essential medicines

• Average availability in Africa is only 38% in the public sector and 59% in the private sector.

• Public sector availability of medicines is consistently lower than in the private sector.

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Fig 1. Trends in percentage availability of medicines in the hospitals and health centres in the public sector April 2006-July 2008

69%

57%

63%

67%

75%

70%

65%68%

25%

36%

42%

50% 50%

56.30%

33%

50%

0%

10%

20%

30%

40%

50%

60%

70%

80%

Apr-06 Jul-06 Oct-06 Jan-07 Apr-07 Jul-07 Oct-07 Jan-08 Apr-08 Jul-08

Month

Perc

enta

ge a

vaila

bilit

y

Hospitals Health centres

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Barriers to access Health system capacity Health budgets Lack of research and development Price Patents Quality of diagnosis Accurate prescribing Selection, distribution, dispensing of medicines Medicine quality

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Price of essential medicines

• Lowest-priced generic medicines cost 6.4 and 2.5 times international reference prices (IRPs) in the private and public sectors, respectively.

• Add-on costs in the supply chain can more than double medicine prices in the private sector. Public sector mark-ups can also be substantial.

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Barriers to access Health system capacity Health budgets Lack of research and development Price Patents Quality of diagnosis Accurate prescribing Selection, distribution, dispensing of medicines Medicine quality

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Public expenditure on medicinesThere is wide variation in national per capita spending on

medicines by the public sector, ranging from US $0.04 to $187.30 among developing countries.

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Availability of Artemether/lumefantrine 20/120 mg in Kenya

3 4

91

7276

86 86

31

36

5861

68

0

10

20

30

40

50

60

70

80

90

100

Apr-06 Jul-06 Oct-06 Jan-07

% a

va

ila

bil

ity

public sector facilities

private sector facilities

mission sector facilities

Global Fund grant start date (02/2006)

Increased financial support and differential pricing can have a dramatic impact on

medicine availability

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Barriers to access Health system capacity Health budgets Lack of research and development Price Patents Quality of diagnosis Accurate prescribing Selection, distribution, dispensing of medicines Medicine quality

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R&D: for real health needs?

Trouiller et al., Lancet 2002, 359:2188-94; updated figures: Torreele, Chirac 2005

• 1999-2004: 163 NCEs, including 3 new medicines for neglected diseases

1975-1999: 1,393 new chemical entities (NCEs) marketed; only 1% of new medicines developed were for neglected diseases

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Barriers to access Health system capacity Health budgets Lack of research and development Price Patents Quality of diagnosis Accurate prescribing Selection, distribution, dispensing of medicines Medicine quality

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Which society benefits?

‘Patents constitute a temporary monopoly, but in the end society benefits’

Fred Hassan, CEO of Schering-Ploughand president of IFPMA

10 Oct 2006

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20 year patent on medicines 1995: WTO TRIPS Agreement outlines the

“minimum standards” for national legislation on IP – concern arose on the effect of TRIPS on access to essential medicines

2001: WTO Ministerial Doha Declaration on TRIPS and Public Health “… TRIPS …does not and should not prevent… measures to protect public health…”

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Generic medicines Equivalent copy of an originator medicine Undergoes strict scrutiny before it is

licensed and given market approval by the NMRA

In Africa, health systems and budgets depend on generic medicines PEPFAR’s purchase of generic ARVs

resulted in cost-savings up to 90%

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Effect of Generic Competition

Source: http://www.msfaccess.org/fileadmin/user_upload/diseases/hivaids/Untangling_the_Web/Untanglingtheweb_July2008_English.pdf

Effect of generic competition

www.msfaccess.org

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Barriers to access Health system capacity Health budgets Lack of research and development Price Patents Quality of diagnosis Accurate prescribing Selection, distribution, dispensing of medicines Medicine quality

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Substandard medicines “genuine” medicines which do not meet quality

specifications set for them contamination (impurity) too much active ingredient (toxicity) or too little active

ingredient (ineffective treatment; resistance) Failure may be due to

poor manufacturing, storage and / or distribution conditions (accidental or lack of resources / expertise)

weak medicines regulatory agencies lack of information / reporting

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Sub-standard AMs in Kenya: a sampling of studies

Study Results Comments

Bate 2008 35% of the samples failed either or both tests (assay and dissolution)

retail sector AEI is an American neo-con think tank; pro-big-pharma

Atemnkeng 2007

37.5% AMs did not meet Ph. Eur. content requirement of 95 – 105% active ingredient.

Kenya and DRC retail sector

PPB 2006 16% AMs failed QC testing unpublished report all three health sectors surveyed

Amin 2005 45% of AMs were sub-standard retail sector

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Anti-counterfeit initiatives: a NEW barrier to access??

Health system capacity Health budgets Lack of research and development Price Patents Quality of diagnosis Accurate prescribing Selection, distribution, dispensing of medicines Medicine quality Anti-Counterfeit initiatives…?!!?!!

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Counterfeit medicines: definitions

WTO TRIPS: trademark infringement WHO:

deliberately and fraudulently mislabeled with respect to identity and / or source

can apply to both brand and generic medicines may include medicines with the correct active

ingredients, with insufficient active ingredients or with fake packaging

IMPACT… Country legislations…

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Advocating for public-health friendly Anti-Counterfeit initiatives

Kenya ongoing efforts to address the Act’s weaknesses (attempting amendments; supporting the Constitutional Court case; media)

Uganda collaborative efforts to improve the draft Bill

Tanzania identifying issues and finding partners Zambia CSO meeting 11 Dec Ghana...? South Africa...? Zimbabwe…? other countries? EAC Policy on IPRs and Anti-Counterfeiting

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