E-DRUG: Speaker notes EP roundtable Friday 19 June 2020
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Ellen 't Hoen, Medicines Law & Policy
On 23 March Dr Tedros WHO DG declared COVID-19 a pandemic. There are
currently hardly any effective drugs, there are no vaccines and health
systems are scrambling to deal with the pandemic.
Clearly new medical tools are needed and research activities to develop
these tools are taking place at a rapid speed.
When new health technologies become available - they should be available at
affordable prices; large scale production should be able to take place on
different continents, So these drugs and vaccines and other health
technologies become available to all nations on the planet
The likelihood of this happening automatically is not very great.
There are lessons to be drawn from the HIV pandemic that we now need to
apply to COVID-19. Let's not repeat the mistakes that were made in the late
90s when effective antiretroviral treatments became available but only for
wealthy nations. It took more than a decade for the drugs to start becoming
available to the 30 million people in the developing world.
Financial, regulatory and patent barriers stood in the way of assuring that
people had access to antiretrovirals. In 2010 the Medicines Patent Pool
(MPP) was established by UNITAID and this cleared the patent barriers to
access to medicines needed to treat HIV. The MPP was set up to negotiate
patent licenses with pharmaceutical companies for antiretroviral treatments
needed for the treatment of people living with HIV. These licenses make it
possible for multiple generic companies to produce low priced generic
versions of these medicines on a large scale and distribute them in
countries that are part of the license agreement. The MPP is an important
initiative that today holds the IP of all essential antiretroviral
medicines recommended by the WHO. This is an enormous achievement for which
also the companies that have licensed their IP to the MPP should get
credit. But we also have to acknowledge that it was established 20 years
after the first antiretroviral medicines became available in the US and
Europe. That was 20 years too late. The MPP should have been created in
1990, not in 2010.
So what does this mean for Covid-19?
It is no secret that pharmaceutical companies will see commercial
opportunities of the Covid-19 outbreak. And it is important to guard
against the pursuit of profits becoming a barrier to achieving global
equitable access to therapeutics, vaccines and diagnostics.
Research and development including by for-profit companies and public
research institutes benefit from huge public investments - The public
sector with 10 bn Euro for the development of therapeutics, diagnostics and
vaccines is steering and bankrolling this innovation. And the expectations
are high In particular with regard to a covid-19 vaccine.
Political leaders have been outspoken about their access ambitions for the
potential Covid-19 vaccine. Angela Merkel referred to it as a global public
good (Angela Merkel), we heard a vaccine without monopoly, or in the words
of President Macron 'no one can own this vaccine'. Echoing Jonas Salk's
response when he was asked the question who owns the patent on his polio
vaccine - well the people. Can you patent the sun?
Salk put his words into action to ensure that no-one indeed could own his
vaccine and to ensure that it could be made available and used at low cost
across the globe. We all know the tremendous health benefits that brought.
Political leaders now have to do the same to ensure that potential Covid-19
vaccines, therapeutics and diagnostics will be available to all.
And there now is a global mechanism to do this:
On 1 June, the World Health Organization announced the establishment of the
COVID-19 Technology Access Pool - C-TAP. C-TAP is set up to gather patents
and all other forms of intellectual property, know-how, data, trade
secrets, software, blueprints etc. necessary to expand the development and
production of new technologies needed in the response to the pandemic.
C-TAP, like the Medicines Patent Pool, is a voluntary mechanism. There is
currently no international instrument to force the sharing of knowledge and
IP.
The success of C-TAP will depend on the political support it will receive.
So far 38 countries, including a number of EU member states (but not
France and Germany), have endorsed the Solidarity Call to Action that
established the C-TAP.
The European Commission hosted a hugely successful pledging conference that
brought together close to 10 billion Euro for the development of new
COVID-19 health technologies. The EU now should also lead to ensure that
these public resources that are allocated for the development of new drugs,
vaccines and diagnostics are spent under the condition that the knowledge
and technology developed with this money is open and accessible and shared
through the WHO Covid-19 Technology Access Pool. This will help with the
science which will benefit from sharing of knowledge and it will help
access by increasing and diversifying production capacity around the world.
The EU should also lead to ensure that once a vaccine exists that health
care workers - and that must include the 65 million health care workers in
the developing world - are first in line before low risk groups receive the
vaccine. In the last few weeks we have seen groups of EU countries do the
very opposite by manoeuvring themselves to the front of the line by placing
advanced orders for vaccines (that do not yet exist). [The 4 country
alliance (NL,FR,Ger,Italy) is suspended after criticism and is now joining
the EC effort to purchase vaccines].
The EU should also lead the quest for greater transparency about how public
money is spent, transparency with regards to the cost of R&D and pricing.
We hear promises by companies of not for profit pricing but it is unclear
how that will be determined and by whom. Charitable foundations that fund
vaccines require global access provisions but transparency about whether
and how those materialise is lacking.
Last year the World Health Assembly adopted a landmark resolution to
advance much needed transparency in the pharmaceutical sector and COVID-19
spending is an opportunity to implement these transparency requirements
throughout the EU.
Members of the European Parliament can play a crucial role in ensuring that
the public's money is spent wisely, in a transparent manner and with
conditions attached that advance the open sharing of knowledge and IP en
equity in global distribution once products and especially vaccines become
available. The public investments being made today, should lead to public
benefits for all in a spirit of global solidarity.
Thank you for your attention.
Ellen 't Hoen, LLM PhD
Medicines Law & Policy
www.medicineslawandpolicy.org
e-mail: ellenthoen@medicineslawandpolicy.net