Berkeley Declaration on Global IP Enforcement

On July 7-8, numerous scholars and practitioners attended a conference hosted by Berkeley Law Center for Technology and Science to discuss recent challenges affecting global access to medicines.  The discussions centered around three recent initiatives of "IP enforcement" including, primarily, the Anti-Counterfeiting Trade Agreeemnt (ACTA), the East African Community (EAC) anti-counterfeiting draft legislation, and the European Union's (EU) role in the enforcement agenda.

Anti Counterfeiting Trade Agreement--a proposed multi-lateral agreement focusing on the normalization of international IP rights enforcement.  However, current drafts of the Agreement raise concerns that it will actually inhibit access to high quality and affordable essential medicines.  Some concerns raised regarding ACTA include:

• ACTA, as currently drafted, alters IP law in a substantive fashion.  
• ACTA creates a presumption of infringement often leading to increases in the transaction cost of importing generic medicines
• The Agreement introduces the theory of intermediary liability potentially causing a chilling effect on distributors, importers and organizations who provide LMI countries with access to essential medicines
• Transfer of a traditional private right (owned by the individual right-holder) to public enforcement
• Contains ex officio provisions that empower customs officials to determine if a product is infringing on intellectual property rights.  These provisions eliminate many of the traditional Due Process protections essential to the protection of human rights
• Imports areas of EU trademark law into the essential medicines arena and under some drafts of ACTA, a drug's taste, color and dosing regime could potentially be considered evidence of infringement
• ACTA does not address the protection of quality, safety and efficacy in medicines.  Specifically, the Agreement fails to consider unsafe marketing practices by pharmaceutical companies, the enforcement of different quality standards for drugs produced for domestic use versus those for export, and the suppression of clinical trial results.
• Undermines key public health safeguards under TRIPS

EAC Anti-Counterfeiting Draft Legislation--Potential concerns include:

• Provisions of this draft legislation contain strict IP protections for foreign patents that go well beyond the requirements of current treaties
• Member nations of the EAC have previously negotiated the right to produce patented essential medicines; this legislation, if enacted, would require them to unilaterally renounce these rights.
• The proposed law would place an unnecessary burden on the flow of information that is imperative for the development of local competitive pharmaceutical companies and competition in the global economy.

EU Global Enforcement Agenda--The EU has aggressively used free trade agreements to export its IP enforcement policies to LMI countries.  This attempt to impose EU norms on LMI countries raises several causes for concern, including:

• EU nations have used a "fiction of production" theory to enforce local IPR rights that are merely in transit through its countries.  This enforcement tactic has resulted in several seizures of generic essential medicines even where the drugs comply with the IP laws of both the originating and destination countries.  Future shipments may result in higher transit costs where companies feel that they must route around the EU to avoid these drug seizures.
• The EU has utilized expedited legal procedures that allow customs officials to destroy goods before a court hearing is held to determine if a local patent has actually been infringed upon.  

Due to these concerns discussed at the conference, participants at the meeting drafted a declaration highlighting the concerns of global IP enforcement and access to medicines.  UAEM, together with Knowledge Ecology International, Public Citizen, Health Action International Africa, and Third World Network (among others), signed onto the "Berkeley Declaration" which recommends:

• Responsible enforcement initiatives must not interfere with access to medicines and should be grounded in human rights principles; protect innovation, competition and consumer rights; be negotiated through a transparent, inclusive and open process that does not bypass existing multilateral institutions; and protect the full use of TRIPS flexibilities that promote access to medicines.
• Abandonment of ACTA due to its key provisions and lack of transparency.  
• Moratorium on the export of EU policies to LMI countries and drug seizures (which can pose a threat to access to medicines).
• Discarding of the EAC "anti-counterfeiting" draft policy because of its imposition of unprecedented IP norms at the regional level and TRIPS-plus provisions.  
• All developing countries reject any IP enforcement or "anti-counterfeiting" measures that affect the ability to produce, export, import and use generic medicines.
• Improved South-South collaboration in developing frameworks for IP enforcement from a public health perspective.
• WHO should take a public health approach to the problems of medicines quality, safety, and efficacy with the intention to strengthen drug regulatory authorities, ensure the accessibility (including availability and affordability) of medicines, and require transparency and accountability from the pharmaceutical industry.  
• WHO member states should implement the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property.