Oireachtas Joint and Select Committees

Wednesday, 11 May 2022

Joint Oireachtas Committee on Jobs, Enterprise and Innovation

WTO Agreement on Trade-Related Aspects of Intellectual Property Rights and Covid-19 Vaccines: Discussion

Mr. Matt Moran:

Having worked for many years in pharmaceutical manufacturing, I think it is quite easy to do fairly general studies of potential capacity or capability within any country in the world. Normally, what the pharmaceutical industry does and has done is enter into licensing agreements and technology transfer agreements to ensure the capability is present and that they are able to manufacture these products and the ingredients. To underestimate the complexity of what is happening here is a bit of a risk. For instance, to make an mRNA vaccine that is made currently by Pfizer-BioNTech requires in excess of 280 different components, 46 different countries need to supply ingredients and there has to be a laboratory that can conduct more than 50 tests on the product. The capability is not necessarily there. The risk is that if one asks a company that does not have the capability to engage in manufacturing and supply, one is risking diversion of raw materials away from manufacturing and risking producing products which might be substandard, which is a risk to society and health.

The answer really is that, yes, the industry is keen to enter into joint agreements on a voluntary basis, which it has done and there are in excess of 350, as Mr. O'Connor referred to in his presentation. They scour the world all of the time for new arrangements and, recently, joint licensing agreements have been agreed on the African continent between major pharmaceutical companies and local suppliers, and they will continue to do that.

Again, to put this in context, to establish a pharmaceutical manufacturing plant takes approximately two to three years in terms of the capital investment required, the regulatory approval required, the validation required and the training of people. It is not something that is easily accessible. I would congratulate the organisation Mr. O'Connor refers to with regard to establishing manufacturing on the African continent because it needs to be done, but it is not something that is going to happen overnight. It is an area where we need to be very careful in terms of how we manage and deal with it. The industry is keen to do this and has been doing this, and the evidence of that is the number of joint licensing agreements achieved. Indeed, the committee is probably aware of the significant amount of vaccine that has been manufactured in India by the Serum Institute through an agreement it has with AstraZeneca.

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