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[e-lek] WHO DG's final WHA speech - many medicines policy references

E-DRUG: WHO DG's final WHA speech - many medicines policy references
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Dear E-druggers

I was particularly struck this afternoon at how many times the outgoing WHO
DG, Dr Chan, mentioned medicines policy issues. Of course, one could
question whether HCV DAA prices really have "plummeted" in as many markets
as is necessary. This is an interesting construct: "Relevance is readily
apparent when WHO endorses a new medical product, and partners find ways to
fund it, or issues a position paper on a new vaccine." Her commitment to
UHC remains undimmed: " I regard the 2010 World Health Report, on Health
systems financing: the path to universal coverage, as the most influential
publication issued during my administration."

This is a key observation: "The most contentious issue was access to
medicines, especially when intellectual property and the patent system were
perceived as barriers to both affordable prices and the development of new
products for diseases of the poor." Hence the emphasis on the Global
Strategy and Plan of Action on Public Health, Innovation and Intellectual
Property, the Global antibiotic research and development partnership with
DNDi, the pilot project for prequalifying biosimilar medicines, and the
work on a model for the fair pricing of pharmaceuticals.

And here's a quote to repeat: "The rationale is obvious: universal health
coverage depends on affordable medicines. No country on this planet can
hope to treat its way out of all the diseases affecting their populations."

And finally: "Listen to civil society. Civil society organizations are
society's conscience. They are best placed to hold governments and
businesses, like the tobacco, food, and alcohol industries, accountable.
They are the ones who can give the people who suffer the most a face and a
voice. Above all, remember the people. Behind every number is a person who
defines our common humanity and deserves our compassion, especially when
suffering or premature death can be prevented."

Regards
Andy
~~~

http://www.who.int/dg/speeches/2017/address-seventieth-assembly/en/
Address to the Seventieth World Health Assembly

Dr Margaret Chan
Director-General of the World Health Organization

Geneva, Switzerland
22 May 2017

Madame President, Excellencies, honourable ministers, ambassadors,
distinguished delegates, friends and colleagues, ladies and gentlemen,

I thank Member States for the trust shown when you appointed me as your
Director-General more than ten years ago. I promised to work tirelessly,
and have done so, but never got tired of the job, in the best and worst of
times.

When I took office, I also promised that I would hold myself accountable
for the Organization's performance. This month, I have issued a report
tracking how public health evolved during the ten years of my
administration.

The report sets out the facts and assesses the trends, but makes no effort
to promote my administration. The report goes some way towards dispelling
the frequent criticism that WHO has lost its relevance. The facts tell a
different story.

The report covers setbacks as well as successes and some landmark events.
Above all, it is a tribute to the power of partnerships and the capacity of
public health to take solutions found for one problem and apply them to
others.

As just one example, it took nearly a decade to get the prices for
antiretroviral treatments for HIV down. In contrast, thanks to teamwork and
collaboration, prices for the new drugs that cure hepatitis C plummeted
within two years.

This is the culture of evidence-based learning that improves efficiency,
gives health efforts their remarkable resilience, and keeps us
irrepressibly optimistic.

We falter sometimes, but we never give up.

Excellencies, ladies, and gentlemen,

As I speak to you, the political and economic outlook is much less
optimistic than it was when I took office in 2007.

That was before the 2008 financial crisis changed the economic outlook from
prosperity to austerity almost overnight, with effects on economies and
health budgets that are still being felt.

That was before acts of international terrorism and violent extremism
became commonplace, before the word "mega-disaster" entered the
humanitarian vocabulary, before seemingly endless armed conflicts caused
the largest population displacements and flights of refugees seen since the
end of World War II.

That was before the alarming frequency of attacks on health facilities and
aid convoys made a mockery of international humanitarian law. We condemn
all these attacks on health care facilities and workers. According to
reports consolidated by WHO, more than 300 attacks on health care
facilities occurred in 2016 in 20 countries, with the majority documented
in the Syrian Arab Republic. We are also seeing how a world full of threats
can toss out deadly combinations, like the dual threats from drought and
armed conflict that have brought famine to parts of Africa and the Middle
East on a scale never experienced since the United Nations was founded in
1945.

The world was fortunate that the 2009 influenza pandemic was so mild. The
world is fortunate that the new viruses that emerged to cause MERS in 2012
and human cases of H7N9 avian influenza in 2013 are not yet spreading
easily from person to person. But they have the potential to do so and we
dare not let down our guard.

The world was less fortunate with Zika, an outbreak that WHO continues to
monitor closely. The world was not at all fortunate with the 2014 Ebola
outbreak that utterly devastated the populations of Guinea, Liberia, and
Sierra Leone. This was West Africa's first experience with Ebola, and the
outbreak took everyone, including WHO, by surprise.

WHO was too slow to recognize that the virus, during its first appearance
in West Africa, would behave very differently than during past outbreaks in
central Africa, where the virus was rare but familiar and containment
measures were well-rehearsed.

But WHO made quick course corrections, brought the three outbreaks under
control, and gave the world its first Ebola vaccine that confers
substantial protection. This happened on my watch, and I am personally
accountable.

I saw it as my duty, as your Director-General, to do everything possible to
ensure that a tragedy on this scale will not happen again. History will
judge whether the new emergencies programme has given the world a stronger
level of protection.

Ultimately, health systems with International Health Regulations core
capacities must be strengthened in your countries to detect unexplained
deaths much earlier. This is critical for improving global health security
to protect our common vulnerability.

Last week, the Democratic Republic of Congo confirmed a new Ebola outbreak
near the border with the Central African Republic. This is the country's
eighth Ebola outbreak. In its last outbreak, which coincided with the West
Africa outbreak, DRC interrupted transmission within six weeks. Despite
enormous logistical challenges, discussions engaging DRC continue about
possible use of the new vaccine to augment the response.

The Ebola outbreak in West Africa had a number of spillover effects which
can be judged more immediately. During the outbreak, WHO acquired extensive
experience in facilitating R&D for new medical products, but poor
coordination lost too much time. To speed things up, WHO and its partners
finalized an R&D blueprint in 2016.

By setting up collaborative models, standardized protocols for clinical
trials, and pathways for accelerated regulatory approval in advance, the
blueprint cut the time needed to develop and manufacture candidate products
from years to months.

The expert consultations that designed the blueprint led to the
establishment of the Coalition for Epidemic Preparedness Innovations,
announced in January 2017 with initial funding of nearly $500 million.

The Coalition is building a new system to develop affordable vaccines for
priority pathogens, identified by WHO, as a head-start for responding to
the next inevitable outbreak.

The world is better prepared but not nearly well enough.

Excellencies, ladies, and gentlemen,

The relevance of WHO's work is demonstrated in many ways, some more visible
than others.

The chronology of the HIV, tuberculosis, and malaria epidemics shows direct
links between WHO changes in technical strategies and turning points in the
disease situation.

WHO also made scientific breakthroughs more democratic by translating
findings into a public health approach that works everywhere, even in
extremely resource-constrained settings.

Relevance is readily apparent when WHO endorses a new medical product, and
partners find ways to fund it, or issues a position paper on a new vaccine.
Many national immunization programmes will not introduce a new vaccine
until WHO has issued its formal seal of approval. Such approval triggers
actions by Gavi, the Vaccine Alliance, to scale up access dramatically.

The prequalification programme is now firmly established as a mechanism for
ensuring that the quality, safety, and efficacy of low-cost generic
products match those of originator products. For example, by the end of
2016, WHO had prequalified more than 250 finished pharmaceutical products
for treating HIV-related conditions. This stretches the impact of funding
agencies, like the Global Fund, in significant ways.

The relevance of WHO was most dramatically demonstrated during last month's
global partners meeting on the neglected tropical diseases.

Participants assessed, and celebrated, ten years of record-breaking
progress that promises to eliminate many of these ancient diseases in the
very near future. This is one of the most effective global partnerships,
also with industry, in the modern history of public health.

The fact that, in 2015, nearly one billion people received free treatments
that protect them from diseases that blind, maim, deform, and debilitate
has little impact on the world's geopolitical situation.

The people being protected are among the poorest in the world. But judging
from the massive amount of media coverage, which included entry into the
Guinness World Records for the most medication donated, this was a success
story that the world was hungry to hear.

Less visible relevance comes from the way WHO has built a safety net that
encircles the globe in the form of thousands of laboratories specialized in
the surveillance and diagnosis of priority pathogens, hundreds of
collaborating centres, and a vast network of scientific boards and
strategic advisory groups. I thank the scientific institutions in your
countries for contributing to the work of WHO.

No other health agency has this degree of technical expertise ready-to-hand.

Excellencies,

The resolutions you adopt also shape the health situation, especially by
raising the profile of neglected problems. For example, the comprehensive
mental health action plan, adopted in 2013, definitively took mental health
out of the shadows and into the spotlight.

Likewise, beginning in 2010, viral hepatitis appeared as a stand-alone
agenda item at three sessions of the World Health Assembly, contributing
greatly to the international priority now given to this disease.

But the strongest call for action comes from high-level political
commitment. This happened in 2011, when the United Nations General Assembly
adopted a political declaration on noncommunicable diseases and again in
2016, when a political declaration gave full attention to antimicrobial
resistance.

Both political declarations responded to a crisis in ways that triggered
broad-based urgent action to find solutions.

Excellencies, ladies, and gentlemen,

I regard the 2010 World Health Report, on Health systems financing: the
path to universal coverage, as the most influential publication issued
during my administration.

It launched what is now a movement towards universal health coverage and
inspired the 2012 UN General Assembly resolution that paved the way for
inclusion of UHC in the Sustainable Development Goals. Our actions under
the 2030 Agenda for Sustainable Development must be guided by the 5 Ps:
people, planet, peace, prosperity, and partnership.

The recommendations that I most want to see implemented are those made by
the Commission on Ending Childhood Obesity.

Childhood obesity is the most visible, and arguably the most tragic,
expression of the forces that are driving the rise of NCDs. It is the
warning signal that bad trouble, in the form of more heart disease, cancer,
and diabetes, is on its way.

The initiatives we all most want to succeed are those for the eradication
of polio and guinea worm disease. For both, the world has never been so
close. We must keep up our efforts to make eradication a reality.

The trend that most profoundly reshaped the mind-set of public health was
the rise of chronic noncommunicable diseases. This shift in the disease
burden called for a move away from the biomedical model of health and its
emphasis on curing diseases to a much broader approach based on prevention.

I regard Every Woman Every Child as the most game-changing strategy during
my administration.

Its adoption by the UN in 2010 captured financial support in the billions
of dollars and launched a number of initiatives aimed at implementing its
recommendations. Maternal and child deaths dropped dramatically.

The related WHO Commission on information and accountability for women's
and children's health added greatly to the culture of measurement and
accountability. As set out in this year's World Health Statistics report,
nearly half of all deaths worldwide now have a recorded cause of death.
This is huge progress. I thank all countries that have made a special
effort on this front.

The most contentious issue was access to medicines, especially when
intellectual property and the patent system were perceived as barriers to
both affordable prices and the development of new products for diseases of
the poor.

The negotiations that led to the establishment of the Pandemic Influenza
Preparedness Framework were tense, to say the least, but ultimately
successful, as were those that led to the Global Strategy and Plan of
Action on Public Health, Innovation and Intellectual Property.

Fortunately, several new initiative and public-private partnerships are
contributing to both objectives. One example is the new Global antibiotic
research and development partnership, launched last year by WHO and the
Drugs for neglected diseases initiative (DNDi).

This is a needs-driven R&D initiative initially focused on the development
of new antibiotics for treating sepsis and sexually transmitted infections,
most notably gonorrhoea. The partnership aims to promote access and to
ensure that prices are affordable.

Earlier this month, WHO announced the launch of a pilot project for
prequalifying biosimilar medicines, a step towards making expensive cancer
treatments more widely available.

WHO is also working with partners on a model for the fair pricing of
pharmaceuticals. The rationale is obvious: universal health coverage
depends on affordable medicines. No country on this planet can hope to
treat its way out of all the diseases affecting their populations.

Excellencies, ladies, and gentlemen,

I will conclude with some brief advice that you may wish to consider as you
continue to shape the future of this Organization.

WHO stands for fairness. Continue to make reductions in inequalities a
guiding ethical principle.

What gets measured gets done. Continue to strengthen systems for civil
registration and vital statistics and continue to make accountability
frameworks an integral part of global health strategies.

Scientific evidence is the bedrock of policy. Protect it. No one knows
whether evidence will retain its persuasive power in what many now describe
as a post-truth world.

Vaccine refusals are at least one reason why the tremendous potential of
vaccines is not yet fully realized. The current measles outbreaks in Europe
and North America should never have happened.

Push for innovation. Meeting the ambitious health targets in the
Sustainable Development Goals depends on innovation. Innovation that uses
country experiences can be frugal and transformative. For example, the R&D
partnership that gave Africa its meningitis A vaccine has transformed the
lives of millions of people.

Safeguard WHO's integrity in all stakeholder engagements. The Framework for
engagement with non-state actors is a prime instrument for doing so. Many
other UN agencies are following WHO's lead with this framework.

While ministries of health are our principle partners, the multiple
determinants of health demand engagement with non-health sectors,
communities, and partners, businesses, and civil society organizations.

Listen to civil society. Civil society organizations are society's
conscience. They are best placed to hold governments and businesses, like
the tobacco, food, and alcohol industries, accountable. They are the ones
who can give the people who suffer the most a face and a voice.

Above all, remember the people. Behind every number is a person who defines
our common humanity and deserves our compassion, especially when suffering
or premature death can be prevented.

Excellencies, ladies, and gentlemen,

This is the last time I will address the World Health Assembly. I thank
Member States for the privilege and honour of serving this Organization. I
have done so with humility, but also with great pride.

I thank my Regional Directors for their wise counsel and their support for
WHO reform, and my wonderful staff at headquarters, in the regional
offices, and in countries, where the impact of our work matters most.

Last but not least, I thank my husband, David, and my family for love and
support. David, thank you for listening.

Thank you.

-- 
Andy Gray BPharm MSc(Pharm) FPS FFIP
Senior Lecturer
Division of Pharmacology
Discipline of Pharmaceutical Sciences
School of Health Sciences
* Consultant Pharmacist (Research Associate)
Centre for the AIDS Programme of Research in South Africa (CAPRISA)
University of KwaZulu-Natal
PBag 7 Congella 4013
South Africa
Visiting Fellow, Faculty of Pharmacy, Rhodes University, Grahamstown
email: graya1@ukzn.ac.za or andy@gray.za.net
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