IPR Waiver and Covid 19 vaccine

It all started with India and South Africa submitting a proposal to WTO in October 2020 on IPR waiver in respect of Covid 19 vaccines. Interestingly, the proposal included waiver on patents, copyrights, designs and trade secrets associated with Covid vaccines. Initially, the proposal was not supported by the developed countries including EU, Japan, USA and UK which disagreed to even discuss the proposal. Some European parliamentarians did recommend to EU to support this proposal after a few months. 

Many other countries are now standing in support of this proposal. Most recently, USA decided to discuss this proposal in WTO. The US posture may be to gain a humanitarian image as it is not clear whether it will support the proposal or discuss it. It may be noted that many US companies are up-in arm against the current US stand and hence, the final US stand in WTO is debatable at this stage. The other countries EU, Japan and UK do not support the proposal even now. 

There is a weakness in the proposal that it is not practical to implement. Each country making use of the proposed waiver, especially developing countries, will find it difficult to manufacture vaccines without the active support of companies owning patents, trade secrets and know how. Patents in respect of all the vaccines in market are not yet granted anywhere and so was the case in October 2020. 

What waiver are we talking about? Perhaps, the thought may have been that the patents, whenever granted, should be waived so that any WTO member could use such patents for manufacturing the concerned vaccines without any risk of infringement. By the time WTO takes up this proposal for discussion, it is going to be few months from now. People familiar with WTO processes realize that any decision on a proposal may take some time, may be few months if all the members agree, as the decision making is through consensus and not through majority voting. We are already in May 2021, 7 months have elapsed since October 2020 and meaningful discussions on the proposal have not really taken place. The original proposal is likely to be modified before serious discussions start. Some indications are already visible. Each government has to further ratify the decision of the WTO to be inline with the local laws. This means more time for starting manufacturing vaccines. 

Technology experts know that a single or even few patents cannot lead to successful manufacturing unless other associated elements are in place. These elements are know-how, trade secrets, raw materials, manufacturing infrastructure, human resources, robust supply chain for raw materials and components like vials etc. Here is a big catch which WTO may not be able to address because most of these essentialities are not within the purview of WTO. 

The codified IPR like patents are in public domain and can be accessed by anyone for information. Such IPRs may be easier to handle through an amendment in TRIPS but it will be difficult, may be impossible, to regulate know-how and trade secrets because these are not in public domain and not accessible to public. Unless the companies holding know how, trade secrets and patents agree to license know how and trade secrets, there is no way for anyone to manufacture vaccines in a short time of few months or years just by obtaining the right to use such patents. Further, there are only a few vaccine manufacturing units in the world, especially in developing countries, hence rightly qualified human resources would be in short supply which are essential for ensuring quality of vaccine. 

In addition to approvals by the drug regulator, certificates for Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) would be required. Therefore, process of obtaining such approvals would be time consuming. The most practical approach on the global front would be to encourage licensing of IPR and total technology from the owners of IPR on terms and conditions which may be applied uniformly across countries. This may be easier said than done because details of licensing agreements would depend on local laws concerning licensing and negotiations between parties. 

Private companies will need to be compensated by somebody. The licensing agreements should include transfer of know-how, licensing of patents copyrights and trade secrets, convenient place for jurisdiction, supply chain etc. One can think in terms of uniform royalty rates and down payments which may be kept as low as possible low. Consideration, cooperation and collaboration (3C) would be essential for a way forward.

  

© R Saha

Next : Compulsory licensing of patents related to Covid 19 vaccine

Previous : The Indian patent law nurtures and promotes innovation