Implementation of Public Health Sensitive Trips Flexibility In The Harare Protocol

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CIVIL SOCIETY OPEN LETTER ON IMPLEMENTATION OF PUBLIC HEALTH SENSITIVE TRIPS FLEXIBILITY IN THE HARARE PROTOCOL
13th November 2019

The undersigned civil society organizations (CSOs) call on Ministers participating in the upcoming ARIPO Ministerial Meeting to establish a transparent Member State TRIPS Flexibilities Working Group that includes participation of civil society as well as experts from UNDP to discuss implementation of public health sensitive TRIPS flexibilities in the Harare Protocol in particular the detailed proposals that have been presented by civil society.

The 16th Session of the Council of Ministers of ARIPO mandated the Secretariat to “explore and formulate concrete proposals aimed at addressing policy and legal incoherence that impact access to health technologies and in the Member States of ARIPO, take actions accordingly and report to the Governing Bodies of the Organization”.

This mandate followed from the 2017 High-Level Meeting on Promoting Policy Coherence on Health Technology Innovation and Access (HLM) in the ARIPO region organized by the Government of Malawi with the support of the United Nations Development Program (UNDP). The HLM identified the following as critical at the Regional Level for improving policy coherence:

  • The need for ARIPO Member States to align the Harare Protocol and ARIPO patent practices with the national public health and industrial policy objectives of ARIPO Member States, including the 13 which are least developed countries, recognizing that all ARIPO Member States have the need to increase affordable access to medicines and vaccines and that some have prioritized local pharmaceutical production.
  • Examining ways of incorporating TRIPS flexibilities including the WTO LDC Waiver;
  • Strengthening the ARIPO patent examination guidelines and practices to incorporate a public health perspective; and
  • Including a regional patent opposition mechanism.

Multiple health challenges affect African countries with severe financial constraints being a major obstacle for African nations. This is especially true as countries move towards Universal Health Coverage, and countries transition out of eligibility of various global health financing programs such as the Global Fund to Fight AIDS, Tuberculosis and Malaria and GAVI and will be expected to increase domestic spending on health and bear the full cost of drugs, vaccines, and other medical technologies.

In addition, African Heads of States have also adopted several regional instruments such as the African Union Commission’s Pharmaceutical Manufacturing Plan for Africa, the East African Community (EAC) and the Southern African Development Community (SADC) pharmaceutical business plans. These strategies and plans aim to address the challenge of access to affordable medicines in the region and increase self-reliance by promoting regional/local generic production. 

Numerous international instruments and expert reports call on countries to make full use of TRIP flexibilities to promote access to health technologies. This includes the 2016 UN Secretary General’s High-Level Panel on Access to Medicines, the WHO Global Action Plan for the Prevention and Control of NCDs 2013-2020[i], the RIO+20 United Nations Conference on Sustainable Development[ii] (UNCSD), the 2018 UN General Assembly Declaration on the Prevention and Control of Non-communicable Diseases[iii]and the 2018 UN General Assembly Declaration on the Fight Against Tuberculosis.[iv]

For ARIPO’s 18 Members States, national implementation of TRIPS flexibilities is insufficient. The majority of pharmaceutical patents are processed by ARIPO, which also administers the granting of patents. Hence Harare Protocol’s rules and ARIPO’s practices have a direct impact on whether a country’s population has access to affordable medicines and whether the ambition of a robust generic industry as envisaged in multiple national and regional pharmaceutical business plans will be realized.

In this context, we are extremely concerned that ARIPO is failing. Key TRIPS flexibilities such as the Least Developed Country (LDC) patent exemption for pharmaceutical products has not been operationalized in the Harare Protocol. Worse still, despite pharmaceutical patents being excluded in some jurisdictions e.g. in Uganda, Rwanda and Liberia, ARIPO continues to persist with granting such patents at the regional level, hence undermining national implementation of the pharmaceutical exemption.

We are also very disturbed by the extremely permissive patent examination rules and lax practices in ARIPO, which has facilitated and supported patent holding companies to continue their notorious practice of ‘patent evergreening’ i.e. prolonging their market monopoly by obtaining patents on simple changes to known compounds. This is an abuse of the patent system for it unduly blocks generic competition, severely undermining access to medicines and public health. Numerous frivolous patents have been granted due to the absence of rigorous patent examination standards and practises. 

The situation is worsened, as other key flexibilities that are common in developed and developing countries such as administrative third party pre and post grant opposition systems are absent from the Harare Protocol. 

To address these policy and legal incoherencies, in June 2019, sixty-one civil society organizations presented concrete proposals to the ARIPO Secretariat building on the discussions and outcome of the 2017 HLM in Malawi. However disappointingly to-date, no action has been taken to initiate a discussion on these proposals, although civil society has expressed a sincere desire to engage constructively engage with the ARIPO Member States on possible reforms to the Harare Protocol to take advantage of public health sensitive TRIPS flexibilities.

Hence, we call on Ministers participating in the upcoming ARIPO Ministerial Meeting to establish a transparent Member State TRIPS Flexibilities Working Group that includes participation of civil society as well as experts from UNDP to discuss implementation of public health sensitive TRIPS flexibilities in the Harare Protocol in particular the detailed proposals that have been presented by civil society.



[i] WHO (2013),“Global Action Plan for the Prevention and Control of Noncommunicable Diseases 2013-2020”.
[ii] United Nations (2012), “The future we want”. RIO+20 United Nations Conference on Sustainable Development, A/CONF.216/L.1.
[iii] United Nations (2018), “Political declaration of the third high-level meeting of the General Assembly on the prevention and control of non communicable diseases” A/RES/73/2 available at https://www.un.org/en/ga/search/view_doc.asp?symbol=A/RES/73/2
[iv] United Nations (2018) “Political declaration of the high-level meeting of the General Assembly on the fight against tuberculosis” A/RES/73/3, available at https://www.un.org/en/ga/search/view_doc.asp?symbol=A/RES/73/3

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