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Statement on behalf of People Vaccine Alliance for US International Trade Commission Investigation

Mister Chairman and Members of the Commission, thank you for the opportunity to testify today on the Commission’s investigation on extending the WTO June decision to diagnostics and therapeutics on behalf of People Vaccine Alliance.

My name is Mohga Kamal-Yanni policy co-lead for the alliance. I have decades of expereince as a doctor delivering medical care and health services in my country and other developing countries, and in research, policy and advocacy.


Like HIV before it, COVID-19 projected a large lens on some societal ailments including inequitable access to medical products. During the height of the HIV crisis, monopoly control over lifesaving ARVs, meant that millions in LMICs died as medicines were unaffordable to people, their governments nor donors. Yesterday, was déjà vu for me listening to industry making exactly the same claims of 2000 on HIV medicines. The entry of Indian generics slashed the price - enabling millions of people to access treatment and be economically and socially active. Generic medicines set the benchmark for prices of newer ARVs ever since.


In fact listening to pharmaceutical companies and IP promotors yesterday and today was a déjà vu for me going back to 2000 where pharma made the same claims they are making now almost word for word.

I shall answer 5 key questions.

1. WHY THE EXTENSION?

During COVID-19, intellectual property monopoly allowed pharmaceutical companies to control three essential decisions related to medical countermeasures: supply, allocation, and price. The result is the obscene vaccine inequality, which is happening with diagnostics and medicines.


That is why 100 countries called for a TRIPS waiver in 2020. This was to enable capable companies in LMICs to maximise production and supply and compete to lower the price so increasing people’s access in developing countries.


After 18 months of intensive questions from opponents and detailed factual answers from proponents, the WTO agreed a very limited decision to one aspect of patent rules for vaccines. Although the decision may not help vaccine production, extension to therapeutics and tests can play an important role in manufacturing and supply of these products to developing countries. Securing a bigger market is an effective stimulus to generic production. A global decision will provide security to countries wishing to issue compulsory licensing to enhance production and supply.


Access to medicines and tests is particularly important for LMICs to deal with COVID given the low vaccination rate. Long illness without medicines takes people out of gainful employment especially those in the informal sector, who do not have paid sick leave or governments’ financial support. Illness increases the burden of caring on women.


2. WHICH MEDICINES?

Three points:

  1. There are several medicines currently used for COVID-19. Moreover, the therapeutic guidelines change according to new medical evidence. Therefore, any decision must cover all COVID-19- relevant medicines.

  2. Most of currently used antivirals is booked for HICs especially the US. After public pressure, the companies agreed voluntary licenses to the Medicine Patent Pool, but with severe limitations. More than 50 developing countries are excluded from one or both licenses, most of which, have large populations that suffer high rate of infection. These countries can source only from the originator companies, at high price.

  3. The extension should cover new medicines that are still in the pipeline. As the virus evolves new medicines and tests are needed. The ACT-A evaluation warned that “realizing the full potential of these new medicines continues to be hampered by limited access to these products for LMICs, unaffordable prices,”.

According to the NIH, there are more than 620 trial sites for COVID-19 medicines. Hundreds more potentially effective medicines are in pre- clinical phases.


3. IS TIERED PRICING NOT ENOUGH?

No. It is not. The price is high for many developing countries. A course of Paxlovid in Panama is $250 - multiple times higher than the estimated price for generic version. Donation: we expect a country to accept as hoc few thousands of doses? How can they plan?


4. IS THERE DEMAND IN LMICS?

In reality, the need for medicines and tests in LMICs is high but concrete demand is difficult because countries face inadequate supplies and high price. Relatives and friends tell us that they cannot afford one test let alone repeated tests or testing contacts.


5. IS FRAGILE HEALTH SYSTEMS THE PROBLEM?

It is true that many developing countries have inadequate health system, but we have heard the same claim against providing ARVs for HIV in Africa. In reality, making the medicines available and affordable reduces the burden on health systems. Some of the HIV infrastructures are used for dealing with COVID-19.


In conclusion: Extending the WTO decision to medicines and diagnostics is critical to deal with the pandemic.

Happy to answer your questions.

Thank you.


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