MSF has documented the problems ACTA will cause for Access to Medicines in details here (Briefing from November 2010):
Since then negotiations have continued and a safeguard allowing parties (countries/states) to the agreement to exclude patents from the scope of the border measures when implementing ACTA if they explicitly request to do so.
However, this does not mean that ACTA is no longer dangerous for access to medicines. Below are some key ways in which ACTA as it currently stands could undermine the ability of people to access medicines.
- Civil trademark cases are still very much part of the enforcement scope and there is no option for countries to exclude this. In reality unnecessary and harmful interruptions to medicine supplies have taken place and will continue if trademark infringement is not also excluded. On 5 May 2009 a consignment of amoxicillin, a generic antibiotic, was stopped in Frankfurt airport by custom officials that suspected the amoxicillin had infringed the trademark ‘Amoxil’ owned by GlaxoSmithKline (GSK). It was released only once GSK confirmed that there was no trademark infringement as amoxicillin is an international non-proprietary name (INN) in the public domain and as such is not the property of GSK. These antibiotics originated in India and were destined for Vanuatu, a least-developed country.
- Patents will only be excluded for a particular party (state) if they explicitly request this. There will be pressure on them to include patents within the scope and it is likely that many countries will do this and therefore all harmful impacts previously outlined apply.
- The enforcement provisions include provisional measures such as the use of injunctions on a mere suspicion or allegation of patent or trademark infringement. This is extremely problematic and goes beyond what is required under the TRIPS agreement. By generally focusing on harsh remedies before infringement has been proven, ACTA will shift the risk on to the generic manufacturers rather than waiting until the IP holder has proved its case. This will have a chilling effect on the manufacturers of generic medicines.
- None of the safeguards in the WTO TRIPS agreement are in ACTA. The obligations of ACTA go way beyond TRIPS, yet whereas TRIPS had corresponding safeguards, ACTA has not included these.
- In the case of proven infringement, damages would be calculated on the basis of the loss to the company who’s IP has been infringed rather than on the basis of the sales made by the infringer. If we take this in the context of the generics medicines industry, rather than calculating damages on the basis of sales of say around $100 per patient per year for HIV medicines, they would take the originator company’s price for those medicines- so in the order of $10,000 per patient per year. This would obviously lead to much higher damages payments and will have a chilling effect on the generics industry as they will not want to risk such huge costs and may therefore stay away from producing medicines where the patent landscape is unclear for fear of an infringement case. As an organisation treating over 170,000 people living with HIV around the world, MSF is concerned about access to the newer drugs patients are starting to need and will increasingly need in the years to come. The patent status on many of these drugs is unclear in key generic producing countries.
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