access to medicines

U N I V E R S I T Ä T S M E D I Z I N B E R L I N


Access 2 Medicines

- how come we can not treat anymore

Dr. Peter Tinnemann, MPH

Institute for Social Medicine, Epidemiology, and Health Economics

Charité – Universitätsmedizin Berlin http://epidemiologie.charite.de


Learning Objectives

• Concept of essential medicines & access

• Factors influencing access to essential medicines

• Explain what Intellectual Property Rights and its

framework is – and how they influence access

– Allow for discussion on changes in EU countries affected

by the ongoing financial crisis


Globalisation, Interests & the Political Landscape

• Pharmaceutical (globalised) Industry

– Global Space & Globalisation as (the only) model of development

– Free movement

– Regulation of Quality, Safety, Efficacy

– Trade Agreements

– Intellectual Property

– Regulation – Intervention in an imperfect market in the public interest

• All interests are affected…

– Civil Society

– Patients (as consumers?)

– Healthcare Professionals

– Pharmaceutical Industry

– Government


As a patient, health professional or medical doctor:

What kind of medicines do you want?

What do you expect from your medicines?

3 min brainstorm, cards & mind-map


Basic global health problem

+/- 350 medicines

– deal with 90% of the

world’s diseases

– yet, are denied to billions

of people in LMICs &

increasingly in HIC

TOO EXPENSIVE or

NOT AVAILABLE

???


Access to essential drugs

– fundamental right to health

– nedicines are NOT simply

another commodity

Framework

WHO framework for access to essential medicines,

http://www.who.int/medicines/areas/access/en/


Access

Unaffordability, def

– share of out of pocket payment is significant and rising

(especially in southern, central & eastern EU member

states)

Unavailabilty, def

– Medicines not available due to stock outs, lack of supply,

lack of cash flow


Factors affecting medicine prices

• transparent price information

• competition & negotiation

• price controls

• reduced duties & taxes on essential drugs

• distribution efficiency

• marketing, distribution & dispensing expenses

• intellectual property protection status


9

Essential Medicines & Health Products (EMP)

• first edition 1977

• revised every two years

• contains 423 medicines

– including children's medicines

– patent status NOT considered in

selection

– has contained 5%-10% patent

protected medicines

http://www.who.int/medicines/en/;

http://apps.who.int/iris/bitstream/10665/112729/1/WHO_TRS_985_eng.pdf?ua=1

http://www.who.int/medicines/en/












WHO perspective

• Intellectual property (IP) / patent protection

– has been an effective incentive for research &

development (R&D) for new drugs,

BUT, should

– be managed in an impartial way

– protect the interests of the patent-holder

– safeguarding public health principles


Definitions

Essential Medicines, def

Essential medicines are those that satisfy the priority health

care needs of the population … selected with due regard to

disease prevalence, evidence on efficacy and safety, and

comparative cost-effectiveness


Definitions

Rational Use of Medicines

“Patients receive medications appropriate to their clinical needs,

in doses that meet their own individual requirements,

for an adequate period of time, and

at the lowest cost to them and their community."

(WHO, 1985)

Irrational Use of Medicines

Patients receive the wrong medications

inappropriate to their clinical needs,

in doses that do not meet their own individual requirements,

for an inadequate period of time, and

at an often unaffordable cost to them and their community.


Conflicting interests

Public (health)

Rational use

of medicines

Pharmaceutical Industry

Maximize sales & returns to shareholders


R&D Modelling

• innovation rewarded with/ IP (patent)

– market monopoly (removes market forces)

• cost of medicines linked to R&D cost

• encourages promotion

• market failure:

no R&D for diseases disproportionately affect the poor


Pharmaceutical Industry R&D

• High ‘costs’ & ‘risks’ in resarch & development

– Development costs: DiMasi $800million

– Development risks: approx. 1 in 10,000 compounds


Access & Research Gap


Research Gap

10/90 gap

< 10% Research

> 90% global disease burden

Ad Hoc Committee on Health Research, Investing in Health Research and Development (1996)

"Report of the Ad Hoc Committee" WHO


Key Problem: Intellectual Property


Harvard Law School (10-02-205)

The South African AIDS Controversy

A Case Study in Patent Law and Policy W.W. Fischer III, C.P Rigamonti

(movie: http://fireintheblood.com/ )

http://fireintheblood.com/


What is a patent?

• Legal document granted by a nation

• Provids owner with certain legal rights

• Limited in time

Owner may exclude others from

– making

– using

– selling

– offering to sell

– importing

the invention


Criteria for patentability

subject matter patentable?

industrial application?

new?

inventive step?


Why patents?

• Commercial advantage in a free

market

– owner can charge a premium, but may

still be subject to competition

– ensure inventors receive an return on

their investment by providing a monopoly

– provide an incentive to innovate

– distribute knowledge: inventor must

disclose the details of his invention

– innovations boost economic performance

Hence, patents lead to

better economic performance!!??


A different point of view…

1. Pressure of competition drives

innovation

2. Public benefits from :

– wider access to knowledge

– lower prices from competition

3. Patents slow technological

progress by

– impeding the dissemination & use of

knowledge

– slowing follow-on research &

innovations

– diverted R&D funding to getting

around patents of others


Generic Competition

• Generic, def

– therapeutical equivalent copy of originator

– Market entry after patent expiration

– Most effective way to lower prices (~25% after 2 years)

• BUT

– rise in expenditure on new (patented) medicines outpace

the savings by generic use…..


Patents: Monopoly Protected

20 yrs (effectively 7̶ 12 yrs)


How A2M became trade-related

• Since early 20th century – harmonize & internationalize IP protection – BUT do not enforcement mechanisms

• In 1980s

– push stronger international protection & enforcement of IP

• Business community

– IP protection = trade-related & belongs to WTO (General Agreement on Tariffs and Trade, GATT)

Agreement on the Trade Related Aspects of Intellectual Property Rights (TRIPS)


Globalisation of Intellectual Property

1980 1990 2000 2010

Glo

ba

l G

lob

al

1994: WTO

Uruguay Round.

TRIPS ratification, key

provisions:

• patent length (≥20 yrs)

• process & product patents

• Transitional periods agreed

(2000 and 2005)

• Burden of proof reversal

2001: WTO

Doha Declaration.

Interpretive statement:

• Health vs. pharma

interests

• Transitional periods

revised (2016)

• Reaffirmed flexibilities

2001: WHO

prequalification.

2003: WTO

Para 6 decision

Countries

allowed to export

in case of a PH

problem.

Growth in

TRIPs+.

IP negotiated

bilaterally i.e.‘

outside of

TRIPS

& the WTO’

1964:

Declaration

of Helsinki.

World

Medical

Association

Ethical

principles

Guiding clinical

research.

TRIPS flexibilities:

“public health crises” can represent “a national emergency or other circumstances of extreme

urgency”, & “emergency” may be either a short-term problem, or a long-lasting situation.

Compulsory Licences: government can license for the production without the consent of the

patent-holder

Parallel Importation: importation without the consent of the patent-holder


WTO – Structure of Agreements

Umbrella AGREEMENT ESTABLISHING WTO

Goods Services Intellectual Property

Basic Principles GATT GATS TRIPs

Dispute Settlement DISPUTE SETTLEMENT

Transparency TRADE POLICY REVIEWS


Trade related aspects of international property rights

„A small group of powerful corporate interests lobbied their

governments to include intellectual property (IP) norms within

the agenda for the negotiations surrounding the General

Agreement on Tariffs and Trade…“ aus Cynthia Ho. „Access to Medicine in the Gobal Economy: International Agreements on patents and related rights.“ 2011 Oxford University Press

„…[TRIPS] had been long sought by the United States and

other advanced industrial countries in order to force other

countries to recognize their patents and copyrights.

(…)

As they signed TRIPs, the trade ministers were so pleased they

had finally reached an agreement that they didn‘t notice they

were signing a death warrant for thousands of people in the

poorest countries of the world.“ aus Joseph Stiglitz „Making Globalization Work“. 2006 Penguin Books


Patents on Medicines!?

Product patents on medicines

are a very recent

Where did the pharmaceutical industry thrive before the 1960s?

In Germany, Switzerland and Italy!

Italy was 5th producer of drugs in the 1970s, its pharmaceutical industry has

now practically disappeared

introduction of stronger patent protection.

1960 1977 1992 1978 1967


NEW Discurs


Voluntary Licensing Mechanisms

• Group/Global Licensing systems

i.e. Medicines Patent Pool

• Company NEVL* agreements:

i.e. Boehringer Ingelheim

*Non-exclusive voluntary licensing (NEVL)

An TNC licenses a patent, for purposes of local production, to a third

party company in a lesser developed country.

Success: Entirely dependent on the terms of the licenses


PUBLICLY financed research


www.med4all.org

Prof. Dr. Christine Godt (Universität Oldenburg)

Dr. Peter Tinnemann (Charité – Universitätsmedizin Berlin)

Dr. Christian Wagner-Ahlfs (BUKO Pharmakampagne)

Funded by


Product Development Partnerships (PDPs)

Krankheit Produkt Art des Produkts PDP

Malaria

Coartem D Medikament MMV

Artesunate Injection Medikament MMV

Euratesim Medikament MMV

Pyramax Medikament MMV

ASAQ Medikament DNDi

ASMQ Medikament DNDi

Leishmaniose

Paromomycin Medikament OneWorld Health

KalazarDetect Diagnostikum IDRI

SSG/PM-Kombination Medikament DNDi

Afrikanische Schlafkrankheit NECT Medikament DNDi

Chagas-Krankheit Pädiatrische Variante von

Benznidazol

Medikament DNDi

Japanische Encephalitis JE Vaccine India Impfstoff PATH

Cholera Oraler Cholera-Totimpfstoff Impfstoff IVI

Meningitis MenAfriVac Impfstoff MVP/PATH

TB

Flüssigkultur Resistenztest (DST) Diagnostikum FIND

Rapid MTB ID Diagnostikum FIND

LPA Line-Probe-Assay Diagnostikum FIND

Minicolumns (mAETC) Diagnostikum FIND

GeneXpert Diagnostikum FIND


Timeline of the Access Movement

1980 1990 2000 2010

Glo

ba

l G

lob

al

1994: WTO

Uruguay Round.

TRIPS ratification.

2001: WTO Doha

Declaration.

2001: WHO

prequalification.

2003: WTO Para 6

decision. Countries

allowed to export

in case of a PH

problem.

Growth in

TRIPs+.

IP negotiated

bilaterally i.e.‘

outside of TRIPS

& the WTO’

1977: WHO Fist

Essential

Medicine List

(EML) 186 drugs

1999: MSF uses funds from Nobel

Prize to Fund new campaign

1997: South Africa New

Medicines Act

2001: UAEM to coordinate efforts

to improve the research, licensing

and patenting decisions of universities

1995: South Africa

became WTO member

1984: USA

Hatch-Waxman

Act (patent term

restoration act)

GFATM (purchasing since 2002):

PEPFAR (purchasing since

2005):

2010

http://en.wikipedia.org/wiki/File:Uaem_logo.jpg


Essential Medicines: supporting countries to

prioritise

Source: http://www.who.int/medicines/services/essmedicines_def/en/index.html

WHO Definition Medicines that satisfy the

priority health care needs of

the population

Criteria • disease prevalence

• evidence on efficacy and safety

• evidence of comparative cost-

effectiveness

Essential Medicines

Lists • available at all times

• in adequate amounts

• appropriate dosage forms

• assured quality

• affordable price


Conflicting interests

Public (health)

Rational use

of medicines

Pharmaceutical Industry

Maximize sales & returns to shareholders


Chico Weekly Record, Chico, California, 11 Dec 1897

Promoting health or pushing medicines?


The Promotion Imperative

Accountability to Share Holders

Incentivised R&D Modelling

Poor Innovation

Disease Mongering

Me-Too Medicines

= to make money

= markets not needs

= not much therapeutic advantage

= ‘new’ non-diseases

= more of the same

– No therapeutic innovation

– Placebo Trials: required to

demonstrate efficacy against

placebo (only)


Types of promotion

• Sales representatives

• Free Samples

• Journal advertising

• Direct-to-consumer advertising (DTCA)

• Funding of physician ‘ key opinion leaders’ (KOL)

• Gifts – large and small

• Sponsoring

– continuing medical education (CME), symposia and conferences

– patient groups, professional societies, guideline development

• Market seeding ‘research’

• Public relations, advertorials, ghostwriting


WHO Ethical Criteria for Medicinal Drug Promotion (1988)

‘…claims concerning medicinal drugs should …

not contain misleading or unverifiable statements or

omissions likely to induce medically unjustifiable drug use or

to give rise to undue risks.’

“Promotional material should not be

designed so as to disguise its real nature.”

“Scientific and educational activities should not be deliberately

used for promotional purposes.’ WHO Ethical Criteria for Medicinal Drug Promotion, 1988

access to medicines

Documents

i n u n

i n factors

i n globalisation

e d i z

v e r s i t t s

n b e r

i n access unaffordability

ua u n