As a treatment provider for LDC, Médecins Sans Frontières (MSF) is deeply concerned about the impact of ACTA as part of a larger enforcement agenda on the production and supply of affordable, legitimate medicines. They urge contracting States not to sign or ratify ACTA unless all concerns related to access to medicines are fully addressed.
MSF relies primarily on generic medicines procured internationally….Many developing countries have no domestic pharmaceutical manufacturing capacity and governments and patients rely on imported generic medicines. Generic competition is the main driver of pharmaceutical price reductions … ACTA is… is the result of the intellectual property enforcement agenda advanced by rich countries, outside of multilateral norm-setting institutions. The enforcement agenda blurs crucial distinctions between types of IP rights and provides excessive punishment, increasing the likelihood that wrongful searches, seizures and legal actions against legitimate suppliers of generic medicines will be carried out. As well it widens the scope of actors that could have penalties brought against them, so that the whole medicines supply chain becomes affected.
Overbroad enforcement measures can threaten access to medicines. The impact of this has already been documented, for example in relation to the 2008 Anti-Counterfeit Act in Kenya which is currently being by challenged people living with HIV.
- ACTA is flawed, with fatal consequences on access to medicines: ACTA locks in the most controversial aspects of US and EU intellectual property enforcement laws, and has insufficient safeguards to prevent abuse and protect the public.
- ACTA does nothing to address the problem of poor quality and unsafe medicines: ACTA is an inappropriate and ineffective response with counterproductive consequences for developing countries.
- ACTA undermines existing international declarations to protect public health:ACTA circumvents the Doha Declaration by restricting the right of countries to act in favour of access to medicines, imposes TRIPS-plus measures, and is not an appropriate standard for developing countries.
– Not be signed and ratified by contracting States unless all concerns related to access to medicines are fully addressed.
– Only be applicable to wilful copyright and trademark counterfeiting on a commercial scale. It should exclude both patents and civil trademark infringement from the scope of the agreement.
– Not establish third party or aiding and abetting liability.
– Not include TRIPS-plus measures on civil and criminal enforcement mechanisms.
– Include protections against abuse, including judicial review, penalties for abusive litigation and baseless allegations, access to information for the alleged infringer,
and the obligation to consider proportionality and the public interests in setting the remedy.
– Ensure that any institutional structure established through ACTA be open and transparent. It should not have the authority to amend ACTA without public scrutiny and approval from elected democratic bodies.