Fix the Patent Laws Coalition supports South Africa and India’s proposal to facilitate access to COVID-19 vaccines

The Fix the Patent Laws Coalition (FTPL), a group of over 40 organisations working to reform South Africa’s patent laws, welcomes the progressive proposal by South Africa and India for a waiver of all intellectual property in respect of COVID-19 related diagnostics, therapeutics and vaccines. We have seen how a lack of access to COVID-19 medical tools threatens countries’ ability to respond to the virus, especially developing countries. We believe that this proposal will promote and expedite equitable access to all health technologies in all countries.

We call on all countries to support the proposal to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council for a temporary waiver of all patents on products needed to test, treat or vaccinate against COVID-19, and to act with urgency. COVID-19 is a global health crisis, and one that affects working-class and poor people disproportionately. The world needs bold steps such as this that prioritise the needs of vulnerable populations above profits and above nationalism.

“While the waiver will not by itself lead to access to COVID-19 health technologies, it is an important step towards equitable access,” says Executive Director at SECTION27 and FTPL member Umunyana Rugege. “In South Africa, we would like to see the draft amendments to the Patents Act published without delay to ensure that the legal environment is readied for the introduction of a range of diagnostics, medicines and vaccines.”

The FTPL coalition has called on the South African government to take the following steps to help fight COVID-19:

  1. Put a temporary moratorium on granting patents on COVID-19 related products as they are proven effective.
  2. Automatic compulsory licensing of COVID-19 related health products with existing or pending patents.
  3. Fix the Patent Laws urgently to ensure use of all legal flexibilities to improve access to health products.

The South African government has shown exemplary leadership on the world stage to ensure that developing and middle-income countries are not left behind while wealthy nations secure deals with pharmaceutical companies, and that monopolies do not stand in the way of widespread African access to COVID-19 vaccines. This is an important opportunity for countries to stand in solidarity and support the call that would ensure all countries stand to benefit from efforts to fight the pandemic. 

South Africa’s leadership of the African Union and initiatives like the COVAX facility, and the Access to COVID-19 Tools Accelerator have put solidarity before nationalism, and FTPL is fully behind our government in its quest to protect public health and ensure equitable access to medical products.

FTPL has joined a global community of civil society organisations calling for the urgent adoption of the Waiver. You can read the letter from civil society here.

Revise WHO biosimilar guidelines urgently

Third World Network asks African civil society organisation to support its letter to the Chair WHO Expert Committee on Biologic Standardisation (EBCS) to revise the WHO biosimilar guidelines. The South African NCDs Alliance has signed.
The content below is from TWN.

In 2014, WHA adopted the resolution on access to Access to biotherapeutic products including similar biotherapeutic products and ensuring their quality, safety and efficacy” (WHA 67.21).

It requests the Director-General: “to convene
t). the WHO Expert Committee on Biological Standardization to update the 2009 guidelines, taking into account the technological advances for the characterization of biotherapeutic products and considering national regulatory needs and capacities and to report on the update to the Executive Board
”. However, till date, the Secretariat has not updated the SBP Guideline.

WHO states that after the adoption of the  WHA resolution   “In April 2015, an informal consultation was organized during which participants from NRAs of both developing and developed countries, as well as from industry, recognized and agreed that the evaluation principles described in the Guidelines were still valid, valuable and applicable in facilitating the harmonization of SBP regulatory requirements globally. It was therefore concluded that there was no need to revise the main body of the existing Guidelines“.

This is a problematic approach and legally wrong. The resolution is clear and it asked the DG to convene the meeting of  WHO Expert Committee on Biological Standardization to update the Guideline and not to convene the meeting of  Expert Committee on Biological Standardization to decide whether to update or not. Further, the decision of  Member states cannot be overturned by the informal meeting of  National Regulatory Meetings. Further WHO has not published any verbatim records or minutes of the 2015 informal meeting.