[Ip-health] Indian Civil Society Statement in IMPACT (16 January 2009)

[Kajal Bhardwaj]

INDIAN CIVIL SOCIETY STATEMENT ON ATTEMPTS AT THE WORLD HEALTH ORGANISATION=
 TO MAINSTREAM TRIPS-PLUS IP ENFORCEMENT MEASURES AND ON THE INTERNATIONAL =
MEDICAL PRODUCTS ANTI-COUNTERFEITING TASKFORCE (IMPACT)
16 January 2009

The upcoming meeting of the Executive Board (EB) of the World Health Organi=
zation (WHO) is scheduled between the 19th and 27th of January 2009 at Gene=
va. Anti-counterfeiting measures including a definition of =E2=80=98counter=
feit medical products=E2=80=99 will be discussed at this meeting. The Inter=
national Medical Product Anti-Counterfeit Taskforce (IMPACT) is leading the=
 negotiations regarding the definition and for the introduction of a resolu=
tion at the next World Health Assembly (WHA). In this regard, the WHO Secre=
tariat has prepared a note titled =E2=80=98Counterfeit Medical Products=E2=
=80=99 which details the work of IMPACT and endorses it. It further suggest=
s a draft resolution for a similar endorsement of IMPACT=E2=80=99s work by =
the WHA and for the continuation of the group for another two years. This i=
s a matter of great concern.

BACKGROUND
Attempts to confuse IP enforcement with public health issues
Over the past several years, multinational pharmaceutical companies and som=
e developed countries have been pursuing what has come to be known as the =
=E2=80=98Intellectual Property (IP) Enforcement Agenda=E2=80=99. This invol=
ves lobbying with governments to introduce strict IP enforcement norms in t=
heir laws and to rope in public authorities funded by tax-payers money to e=
nforce their IP rights. Among these authorities are drug regulatory authori=
ties (DRA). In the past attempts to include DRAs in the enforcement of IP h=
ave included trying to introduce policies such as patent linkages and data =
exclusivity. More recently, attempts have been focused on redefining the te=
rm counterfeit which generally refers to trademark disputes. This has been =
done effectively by blurring the lines between issues of real public health=
 concern (i.e. spurious, substandard and adulterated drugs) with counterfei=
ts. The term counterfeit is increasingly being used to refer to multiple pr=
oblems
 leading to much confusion and the effective introduction of the IP enforce=
ment agenda.

IMPACT: THE =E2=80=9CIP ENFORCEMENT=E2=80=9D AGENDA
IMPACT was launched in 2006 with the WHO as its secretariat to address the =
issue of counterfeiting. Its launch was not sanctioned by any WHA resolutio=
n i.e. by member countries of the WHO. IMPACT works closely with several or=
ganisations such as Interpol, Organisation for Economic Co-operation and De=
velopment (OECD), World Customs Organisation (WCO), World Intellectual Prop=
erty Organisation (WIPO), European Commission and the International Federat=
ion of Pharmaceutical Manufacturers Associations (IFPMA) which are institut=
ions engaged in IP enforcement and in particular in promoting standards tha=
t go beyond the TRIPS Agreement. The majority of IMPACT=E2=80=99s funding i=
s from developed countries including the European Commission who has a reco=
gnized stand on counterfeiting and IPR enforcement.

IFPMA, the organisation of multinational pharmaceutical companies has been =
closely and openly involved in the work of IMPACT. IFPMA heads the Technolo=
gy Working Group of IMPACT and is also a member of its Planning Group.

Of all the work of IMPACT, two activities require urgent attention. One is =
the definition being proposed by this group of the term =E2=80=98counterfei=
t=E2=80=99 which despite several meetings, clarifications and explanations =
continues to include vague terms and combines issues of trademark infringem=
ent, spurious and mislabeled drugs. The definition is being proposed as mod=
el text to be adopted by countries.

By confusing the issues of counterfeit medicines with concerns regarding sp=
urious and mislabeled medicines, IMPACT is following the wrong approach. IM=
PACT=E2=80=99s focus on policy and legislation on counterfeit drugs will be=
 counter productive and will create barriers to trade in and access to legi=
timate medicines. Overemphasis on the need to take measures against counter=
feiting is also drawing the attention of WHO and developing countries away =
from much needed efforts to tackle spurious and substandard medicines. This=
 will in fact benefit the multinational pharmaceutical industry that is kee=
n to enforce its private IP rights through anti-counterfeiting measures.

The second area of concern is a document proposed by IMPACT titled, =E2=80=
=98Principles and Elements for National Legislation against Counterfeit Med=
ical Products=E2=80=99. This document proposes a harsh criminalization and =
enforcement regime and compares counterfeiting with drug trafficking. The p=
roblem with this is that allegations of counterfeiting may actually relate =
to drugs that are safe, legitimate and registered but on which there may be=
 grievances of trademark infringement.

IMPACT: UNDERMINING TRIPS FLEXIBILITIES
The definition proposed by IMPACT and the Principles and Elements for Natio=
nal Legislation against Counterfeit Medical Products=E2=80=99 reflect in la=
rge part the interests of multinational pharmaceutical companies and certai=
n developed countries in putting in place an IP enforcement regime. This is=
 not surprising given the enormous influence they have enjoyed in the worki=
ng of IMPACT. There are also concerns that the new definition undermines TR=
IPS flexibilities such as parallel importation by its use of vague legal la=
nguage.

ACTA, SECURE & IMPACT: SAME ACTORS, DIFFERENT ARENAS
The work of IMPACT must be seen in the light of other actions of multinatio=
nal pharmaceutical companies and some developed countries. Key among these =
is the Anti Counterfeiting Trade Agreement or ACTA being negotiated between=
 certain countries which many public interest groups fear is aimed at intro=
ducing a TRIPS-plus IP enforcement agenda. The World Customs Organisation (=
WCO) is also developing the Provisional Standards Employed by Customs for U=
niform Rights Enforcement or SECURE which promote strict IP enforcement. IF=
PMA, the WCO, INTERPOL, the European Commission and other developed countri=
es are heavily involved in all these initiatives.

It must be noted that the European Union and other developed countries have=
 been working consistently to strengthen intellectual property enforcement.=
 One such mode of enforcement is to amend regulations that govern practices=
 by national authorities including drug regulators, customs, etc. This coul=
d lead to public authorities, seizing or delaying the movement of legitimat=
e generic medicines, on suspicion of being =E2=80=9Ccounterfeit=E2=80=9D. T=
he creation of such barriers will lead to the delay in accessing affordable=
 medicines for patients around the world.

UNDEMOCRATIC AND NON-TRANSPARENT INTERNATIONAL LAW AND POLICY MAKING
The manner in which IMPACT has functioned has completely bypassed the proce=
ss of international negotiations of the World Health Assembly. The recent p=
rocess of drafting and negotiating the Global strategy and plan of action o=
n public health, innovation and intellectual property presents a model of i=
nternational negotiation that involved all member States of the WHO, invite=
d and included experts from across the spectrum and used public health as t=
he fulcrum for the entire process. This is in contrast to the manner in whi=
ch the WHO has approached the counterfeit issue. While the IGWG process was=
 member driven, open and transparent, inclusive of public interest groups a=
nd where international norms were set through negotiations between countrie=
s, the IMPACT process has been driven by a heavy involvement of the private=
 sector, been lacking in transparency and has in effect substituted the pro=
cess of international negotiations between countries in arriving at
 international law and policy.

WHO IS FAILING TO FOCUS ON PUBLIC HEALTH CONCERNS
The report of the WHO secretariat once again emphasizes counterfeit medicin=
es. WHO=E2=80=99s continued focus on counterfeit medicines have also led to=
 concerns that instead of addressing the issue of substandard medicines and=
 spurious drugs that represent a far larger risk to public health, the anti=
-counterfeiting measures it supports may actually create trade barriers tha=
t seriously affect access to legitimate generic medicines.

Its recommendation therefore that the Sixty-second WHA adopt a resolution o=
n counterfeit medical products =E2=80=9Cto establish effective mechanisms o=
f coordination and collaboration among health, enforcement and other releva=
nt authorities in order to improve detection, investigation and prosecution=
 of cases of counterfeit medical products=E2=80=9D, will be counter product=
ive and will in fact be detrimental to public health as it allows the creat=
ion of barriers to the export and import of affordable generic medicines.

The report also endorses the Tunisia IMPACT definition resolution on counte=
rfeit medical products.  The adoption of the definition of counterfeit by I=
ndia and other developing countries will legitimize IMPACT and the resoluti=
on on counterfeit medical products being proposed by the WHO secretariat.

WHILE THE SUBSTANCE OF THE SUGGESTIONS MADE BY IMPACT OVER THE PAST TWO YEA=
RS IS A GREAT CAUSE FOR CONCERN, EVEN MORE WORRYING IS THE MANNER IN WHICH =
THIS GROUP WITHOUT ANY SANCTION FROM THE WORLD HEALTH ASSEMBLY HAS EFFECTIV=
ELY SUBSTITUTED THE DEMOCRATIC BODY OF NATIONS IN MAKING INTERNATIONAL POLI=
CY. IT IS ESSENTIAL THAT INDIA REJECT THE WORKING OF THIS GROUP AND CALL ON=
 THE WHO TO IMMEDIATELY DISTANCE ITSELF FROM IMPACT AND INSTITUTE A TRANSPA=
RENT AND DEMOCRATIC PROCESS TO CONFRONT REAL PUBLIC HEALTH CONCERNS.

In the above background, we call on the Indian government to:

=EF=82=A7=09Reject the report of the WHO secretariat and the draft resoluti=
on on =E2=80=98counterfeit medical products=E2=80=99:  The draft resolution=
 proposed by the WHO secretariat endorses the work of IMPACT and ensures it=
s continuation for at least another three years. This is not acceptable.

=EF=82=A7=09Call on the WHO to withdraw from IMPACT: The funding and functi=
oning of IMPACT has heavily involved agencies that have a clear conflict of=
 interest and that have long been associated with hampering the supply of s=
afe, effective and affordable generic drugs to patients around the world. I=
ndia must call on the WHO to reject IMPACT and institute an open and transp=
arent process in identifying and tackling public health priorities.

=EF=82=A7=09Ensure that the safety, efficacy, affordability and accessibili=
ty of medicines remain the focal points of the work of the WHO:  Strengthen=
 the systems of quality assurance in the procurement of essential drugs by =
developing countries. WHO pre-qualification system for anti-retrovirals has=
 effectively proved that developing countries can not only effectively trea=
t AIDS but also produce the quality low cost generic drugs needed for the s=
ame.

=EF=82=A7=09Call on the WHO to institute an open and transparent process in=
 the identification and tackling of public health priorities: Involve exper=
ts, civil society and governments from developing countries in identifying =
the issues, the negotiations and the development of draft texts of any reso=
lution. All pharmaceutical associations and institutions with IP enforcemen=
t agendas should be prohibited from funding and participating in the negoti=
ations and in policy making.

=EF=82=A7=09Call on the WHO to reject the TRIPS-plus enforcement agenda: Th=
e WHO must reject any and all attempts at bringing in a TRIPS-plus enforcem=
ent agenda whether through IMPACT, ACTA or national legislations.

NATIONAL WORKING GROUP ON PATENT LAWS, ALL INDIA DRUG ACTION NETWORK (AIDAN=
), JAN SWASTHYA ABHIYAN (JSA), ALL INDIA PEOPLE=E2=80=99S SCIENCE NETWORK, =
INITIATIVE FOR HEALTH EQUITY AND SOCIETY, HEALTHWATCH FORUM, DRUG ACTION FO=
RUM- KARNATAKA(DAF-K), CENTRE FOR HEALTH AND SOCIAL JUSTICE (CHSJ), AND CEN=
TRE FOR TRADE & DEVELOPMENT (CENTAD)