IP abuse threatens access to affordable medicines

© Jakub Jirsak – 123RF.com

The TRIPS agreement, administered by the World Trade Organisation, allows for flexibility within patent law in order to address South Africa's massive burden of disease, which includes HIV/AIDS, TB, Hepatitis, Cancer and heart disease.

Speaking at the World Trade Organisation's (WTO) Forum, the International Generic and Biosimilar Medicines Association (IGBA) warned of the potential impact to public health imperatives, should current IP provisions be abused through free trade agreements, which disregard the best-practice framework set out by the WTO for negotiations between countries.

WTO framework undermined

The WTO framework, which governs the rules of multilateral trading between countries, is being undermined as increasing bilateral and plurilateral free trade agreements (FTAs) involving pharmaceutical products are being negotiated outside of these frameworks, thereby disadvantaging the generics and biosimilars industry and denying citizens access to affordable medicines.

"This is especially alarming for developing countries, such as South Africa, where there is pressure to forfeit the provisions brought about by the TRIPS agreement in exchange for economic benefits unrelated to the access of drugs for public health," says Vivian Frittelli, CEO of National Association of Pharmaceutical Manufacturers and Chairman of International Generic Pharmaceutical Alliance (IGPA).

The IGBA is calling for a balanced approach to IP protection based on the standards set out in the TRIPS Agreement and suggests that FTAs could present opportunities to increase market access for the generic and biosimilars industries if a reasonable approach to IP is promoted. The removal of such barriers will reduce costs for the development of generic and biosimilar medicines and ensure that such products can be traded freely and enter markets immediately.

Pressure from US AGOA

The Fix the Patent Laws Coalition, which is made up of the Treatment Action Campaign (TAC), Doctors Without Borders (MSF), Section 27 and the Stop Stock Outs Project (SSP), states, "South Africa is facing pressure from the pharma industry to backtrack on IP law reform, which aims to improve access to medicines, in exchange for eligibility for on-going inclusion in the US' African Growth and Opportunity Act (AGOA)."

At the time of the campaign, Health Minister Dr Aaron Motsoaledi, likened the attempts to deny South Africans access to medicines to genocide and called on citizens to fight against such attempts "to the last drop of their blood".

While South Africa's proposed patent law reforms explicitly recommend that South Africa should not enter into bilateral trade agreements that may negate the gains attained in multilateral agreements, such as the TRIPS Agreement on patent flexibilities, there are fears that lobby groups such as the American Chamber of Commerce to the US government may be causing the delays in finalising these reforms.

The IGBA strongly supports the negotiation of trade agreements aimed at fostering trade in generic and biosimilar medicines. However, the competitiveness of the generic and biosimilar industries is being threatened by regulatory divergences with respect to country requirements for the approval and marketing of generic and biosimilar medicines, and excessive standards for IP protection. Specific instances of IP abuse/misuse, as well as pricing and reimbursement policies are also areas of concern.

Although the text for the recently concluded Trans Pacific Partnership (TPP) agreement has not been formally released, negotiators reported that the US wanted a 12-year data exclusivity period, which would delay the introduction of generic and biosimilar products. It seems agreement was reached on a five-year period.

Trade principles proposed

"To protect countries from manipulation through trade agreements, the IGBA has proposed a set of trade principles on four key priority areas with the objective of fostering trade in generic and biosimilar medicines and increasing patient access to high-quality, affordable medicines," continues Frittelli.

These four key principles should systematically inform trade negotiations globally. They are to:

• Foster regulatory convergence of the requirements for the approval of generic and biosimilar medicines, and recognition of compliance inspections through the establishment of frameworks providing for regulatory cooperation;
  
• Ensure that the regulation of IPs in trade agreements does not lead to excessive IP standards that delay access to generic and biosimilar products;
  
• Establish an appropriate framework of pro-competitive provisions to prevent IP abuse/misuse, and;
  
• Establish an appropriate framework for incentivising generic and biosimilar medicines' market access.

"Systematic application of these principles in all trade agreements will bring about substantial improvements to the regulatory environments affecting generic and biosimilar medicines which in turn will facilitate a direct and positive impact on public health challenges," concludes Frittelli.