PHM-Exch> [PHM NEWS] WHO adopts Roadmap on access to medicines and resolves to promote market transparency
Claudio Schuftan
cschuftan at phmovement.org
Fri Aug 9 19:40:12 PDT 2019
From: David G Legge <dlegge at phmovement.org>
Big Pharma’s pleas rebuffed
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<https://mailchi.mp/1df4fd88dd73/access-to-medicines?e=916df65fd1>
WHO adopts Roadmap on access to medicines and resolves to promote market
transparency
The price of medicines is a major barrier to achieving universal health
cover. The underlying contradiction, between access to medicines and pharma
profit, was on display at the Seventy Second World Health Assembly in May
2019 (WHA72).
The interplay of policy logic and political power was enacted in three
major debates:
- The Roadmap debate (agenda item 11.7) highlighted the role of
intellectual property (IP) protection in keeping prices high and the
significance of the research and development (R&D) expenditure argument in
defending this regime;
- The Transparency debate (also agenda item 11.7) highlighted the
significance of secrecy in keeping prices high (for some) and the critical
importance, for pharma, of keeping secret the real costs of R&D;
- The Substandard &/or Falsified (S/F) debate (agenda item 12.2)
highlighted conflicts over regulatory purpose and role of scaremongering
(over substandard &/or not-approved &/or falsified) in protecting
originator drugs from generic competition.
The Roadmap
In May 2017 the WHA asked the WHO Secretariat to prepare a Roadmap
outlining the programming of WHO’s work on access to medicines and vaccines
for 2019−2023 to be submitted to WHA72 in May 2019.
The proposed Roadmap arose out of a serious tension among member states in
2017 over the report of the high level panel (HLP) appointed by the UN
Secretary General (and hosted by the UN Development Program, UNDP) to
advise on access to medicines. The HLP (appointed in 2015) was a flow on
from the work of the Global Commission on HIV and the Law
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=dc28d8ab7c&e=916df65fd1>
(2010-2012) which was convened by UNDP on behalf of UNAIDS. Several of the
commissioners also served on the HLP. The report of the HLP (September
2016) provided a broad sweep of recommendations (see Executive Summary
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=145f3dc914&e=916df65fd1>)
relating to:
- TRIPS flexibilities and TRIPS-plus provisions (more on TRIPS below);
- publicly funded research;
- new incentives for research;
- stronger accountability of governments;
- a stronger role for the UN SG and UN General Assembly;
- greater disclosure and transparency by corporations;
- complete transparency regarding clinical trials;
- publicly accessible databases regarding patents and related data
regarding medicines and vaccines.
When this came before the WHO Executive Board (EB) in Jan 2017, the USA
(supported by Europe, Switzerland and Japan) was opposed to any
consideration of the HLP report. Contrary views were presented by Colombia,
India, Thailand, Algeria, Brazil, Iran and South Africa
The sparring continued at the WHA70 in May 2017 and was picked up again at
the EB142 in Jan 2018 where a decision was recommended that WHO develop a
Roadmap bringing together all of its various activities around access to
medicines. This was confirmed at WHA71 in May 2018 in WHA71(8)
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=205af9e9f4&e=916df65fd1>
.
WHO already had a range of resolutions on its books regarding various
aspects of medicines policy (regulatory strengthening, rational use,
quality, safety and efficacy, etc) but nothing which effectively addressed
high prices as barriers to access. For many low and middle income countries
medicines account for between 25-60% of their total health expenditure;
hence prices are a priority concern for most countries and affordable
prices a critical prerequisite for universal health cover.
The proposed Roadmap was considered by EB144 in Jan 2019 and forwarded to
WHA72 for confirmation (as A72/17
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=11d6631118&e=916df65fd1>).
The debate over the Roadmap at the Assembly in May 2019, was generally very
positive although there was some disagreement as to whether the Roadmap was
simply a re-packaging of previously mandated resolutions (the US position)
or whether there was some scope for picking up some of the more radical
recommendations of the HLP (in particular, those relating to market
transparency). (When it was clear that this was not going to happen, the
scene was set for the launch of the Transparency Resolution, see below.)
The Roadmap was noted (approved) with the support of many member states.
See PHM commentary and WHO Watch report of this item at WHA72 here
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=24875bd5a7&e=916df65fd1>
.
Several of the issues raised during the debate of the Roadmap warrant
further detail, including: delinking, TRIPS, rational use of medicines, and
budget.
Delinking
One of the main hostilities regarding the HLP report from pharma and its
member state allies concerned its support for delinking and the references
to delinking in the Roadmap attracted sharp words from the US delegation.
Delinking is shorthand for a package of policies aimed at delinking the
funding of pharmaceutical R&D from high profit margins on successful drugs
(recognising also the role of IP protection in maintaining high prices).
Delinking proposals had been under consideration in WHO’s governing bodies
since the 2006 report of the WHO Commission on Intellectual Property
Rights, Innovation and Public Health
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=c3e84d3140&e=916df65fd1>
and the 2012 report of the Consultative Expert Working Group on Research
and Development: Financing and Coordination (CEWG
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=a999f38d6d&e=916df65fd1>)
and a number of initiatives arising from this report had been progressed
although well short of the R&D Treaty many were calling for. The HLP report
of 2016 was strong in its support for delinking, particularly for
treatments for diseases predominantly affecting developing countries, and
suggested that a R&D Treaty could be progressed under the aegis of the UN
Secretary General rather than the WHO.
The opposition of the US to delinking was evident in the US criticisms,
during the EB144 and WHA72 debates, of the references to the CEWG in the
draft Roadmap.
The role of the TRIPS agreement (the World Trade Organisation (WTO)
agreement on Trade-related Aspects of Intellectual Property Rights) in
maintaining high drug prices for longer terms has been contentious within
WHO governing bodies since the adoption of TRIPS in 1994 and was critically
examined by the HLP in 2016.
There are two aspects to the focus on TRIPS: first, the ability of
countries to fully deploy the flexibilities which are built into TRIPS and
as a consequence achieve lower prices; and second, the option of adopting
(or not) TRIPS plus provisions in bilateral or plurilateral trade
agreements. (TRIPS plus provisions include making patenting easier,
patenting new uses of old drugs, extending the term of protection,
harnessing the power of medicines regulatory authorities in policing patent
claims, and authorising direct-to-consumer marketing.)
The HLP recommended that WHO should work with UNDP and the UN Conference on
Trade and Development (UNCTAD) as well as with the WTO and the World
Intellectual Property Organisation (WIPO) supporting countries to ensure
the full use of TRIPS flexibilities. UNDP and UNCTAD are much more
sympathetic to the claims of developing countries, including access to
medicines and UHC, than WTO and WIPO.
Under ‘Provide technical support and capacity-building’ the Roadmap
proposes ‘support for the consideration of public health implications when
negotiating bilateral or multilateral trade agreements’. At the core of
this part is the provision of advice and assistance to countries so that
when they legislate commitments under the TRIPS Agreement they ensure that
they fully enable the use of TRIPS flexibilities and likewise avoid
commitments to TRIPS plus provisions in other trade agreements (bilateral
or regional).
The previous commitment to providing such trade-related technical support (
WHA59.26
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=4ef4e91b30&e=916df65fd1>
in 2006) has largely withered on the vine for lack of funding and periodic
bullying of the Secretariat by the US. Further background regarding the
non-implementation of WHA59.26
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=89be7b5e75&e=916df65fd1>
is provided in PHM’s comment on this item at WHA71, here
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=8a7a4d5151&e=916df65fd1>
.
The trade-related deliverables in the Roadmap were the principal targets
for US criticism at both EB144 (in Jan 2019) and at WHA72 (in May 2019).
The US insisted that WHO work with WTO and WIPO on all issues relating to
IP and trade (and was supported by Canada and Japan in this). However, the
references in the Roadmap to working with UNDP and UNCTAD remain in place.
High prices are a barrier to access but government expenditure is a
function of volume as well as price and one of the drivers of volume is
pharma marketing. It is here that the rational use of medicines and the
regulation of pharma marketing can contribute to ensuring access to
appropriate treatments.
Rational use of medicines
The Roadmap includes a commitment to action around the rational use of
medicines. This commitment dates back to WHA39.27
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=85f23409e8&e=916df65fd1>
in 1986, and has been reiterated in many subsequent resolutions (most
recently WHA60.16
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=da36d69034&e=916df65fd1>
in 2007) but action has been largely stymied through the lack of funding.
The latest report on progress with respect to WHA60.16 (in A72/59
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=de17d76b37&e=916df65fd1>)
advises of action around antimicrobial resistance but provides no evidence
of broader progress regarding the ‘overuse, underuse and misuse’ of
medicines. The report concludes that:
*further efforts are needed to address the rational use of medicines
including through stronger and more focused guideline implementation
activities, by means of national policies and plans integrating WHO
standards and norms with regional initiatives and by investing sufficiently
in human and financial resources as recommended in resolution WHA60.16*
The proposed delinking of R&D expenditure from medicines prices would have
far reaching implications for pharma’s marketing expenditures as well as
access to treatment.
The Roadmap notes, at para 41 that:
*Factors that contribute to inappropriate prescribing, dispensing and use
include an inadequately trained workforce, incorrect diagnoses, the
prohibitive costs or simple unavailability of medicines, and activities
related to product marketing and promotion. Policy approaches and
interventions have been identified to improve the use of health products
but have generally not been implemented over the past decade. *
Despite this recognition there are no ‘deliverables’ in the Roadmap which
might promote the more effective regulation of the marketing of health
products in accordance with WHA60.16
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=7c3de02530&e=916df65fd1>.
(WHA60.16 urges member states to “to enact new, or enforce existing,
legislation to ban inaccurate, misleading or unethical promotion of
medicines, to monitor promotion of medicines”.) While pharmaceutical
companies defend their high profits in terms of the need to recoup
expenditure on R&D, in fact, such companies spend much more on marketing
than they do on R&D; marketing which often drives inappropriate use.
Delinking, through its effect on price, would notionally free up government
resources to invest in health needs directed R&D *and* to invest in the
rational use of medicines. If only a fraction of corporate marketing
expenditure were to be redirected to supporting publicly accountable
independent therapeutic advice platforms, including academic detailing, the
rational and appropriate use of medicines would be greatly improved.
Academic detailing is one of the most powerful tools for promoting rational
use but is not mentioned in the Roadmap.
Budget
A number of speakers at WHA72 (including Brazil and several of the
non-state actors (Save the Children
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=c0e1670115&e=916df65fd1>,
the World Medical Association (WMA
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=cde274b7d3&e=916df65fd1>)
and Medicus Mundi International
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=09f92af6f4&e=916df65fd1>
with PHM and TWN) expressed concern about the funding of the Roadmap.
The budget estimates for Outcome 1.3 of the Programme Budget for 2020-21
(A72/4)
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=7732d1779e&e=916df65fd1>
(improved access to essential medicines, vaccines, diagnostics and devices
for primary health care) project a total expenditure of USD131m per year
which is ridiculously small compared with the activities included under the
Roadmap.
The Secretariat estimates (in A72/17
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=43ebb79727&e=916df65fd1>)
that this funding will be distributed 58% ($76m per year) on regulatory
system strengthening (Output 4.3.3), 11% ($14.4m) on R&D and IP related
activities (Output 4.3.2), and 31% ($40m) on selection, fair and affordable
pricing, procurement and supply chain and appropriate prescribing
dispensing and use (Output 4.3.1).
Compare this budget projection (which is unlikely to be fully subscribed by
the donors) with US pharma expenditure on marketing which Gagnon and Lexin
in 2008
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=7b00be5b9b&e=916df65fd1>
estimated to range from $28-58 billion in 2004. Extrapolating this to the
globe and to the present suggests as much as $1 trillion per year for the
years of this budget.
The donor chokehold over WHO (through the freeze on ACs and the tight
earmarking of donor funds) means that while some deliverables in the
Roadmap may be trickle-funded others will be completely unfunded. In
particular, it is likely that virtually no donor funds will be available to
support technical advice regarding trade negotiations or effective action
on rational use and ethical promotion.
Powerful member states, led by the US, do not want WHO to be effective in
promoting affordable reliable access to safe, effective and appropriately
used medicines and vaccines if, in doing so, it undercuts the interests of
the transnational pharmaceutical corporations.
The three countries which spoke against considering the recommendations of
the HLP at EB140, the US, Switzerland and Japan, are the homes of some of
the biggest pharmaceutical companies in the world. Not only are their
governments harnessed to defend the interests of their corporations but
these are some of the very few countries in the world which are net
‘exporters’ of intellectual property (with implications for their balance
of payments).
The transparency resolution
At the Executive Board in Jan 2019 (EB144) several member states called for
new commitments in the proposed Roadmap which would progress some of the
recommendations of the HLP on access to medicines. Chile said that
mechanisms for promoting market competition and transparency should be top
priorities. Colombia said explicitly that the road map should incorporate
the recommendations contained in the report of the United Nations
Secretary-General’s High-level Panel on Access to Medicines. India called
on the Secretariat to align the draft road map with the recommendations of
the report of the High-level Panel, particularly with respect to the use of
the flexibilities provided in the TRIPS Agreement. Ecuador argued that the
draft road map should include a greater focus on aspects such as the
development of strategies on pooled procurement for purchasing and, in line
with the recommendations of the report of the United Nations
Secretary-General’s High-Level Panel on Access to Medicines, strategies
regarding the adoption and application of rigorous definitions of invention
and patentability that were in the best interests of the public health of
the country.
The USA, on the other hand, was adamant at the Executive Board (and later
at the Assembly) that there would be nothing in the Roadmap which was not
explicitly mandated in previous resolutions.
The scene was set for the Transparency resolution proposed by Italy.
During the EB debate in January 2019 Italy had noted that the draft Roadmap
called for international action to make reporting and the production costs
of cancer medicines more transparent. Thus, she hoped that WHO would take
on a greater role by issuing an appropriate instrument and continuing the
discussion at the Seventy-second World Health Assembly. Similar calls were
made by Portugal, Spain, Chile, Philippines, Bolivia, Russia, Bangladesh
and many of the non-state actors.
On the last day of EB meeting, the Italian health minister wrote to the DG
proposing a draft resolution which would “provide WHO with the mandate to:
collect and analyse data on clinical trial outcomes and adverse effects of
health technologies; provide a forum for governments to share information
on drug prices, revenues, R&D costs, the public sector investments and
subsidies for R&D, marketing costs, and other related information”.
The draft resolution included provisions for transparency in relation to
prices, revenues, units sold, marketing costs, clinical trial enrolments
and outcomes, clinical trial costs, government R&D subsidies, patent
landscapes and manufacturing know-how.
The Italian draft resolution appears to have been prepared for Executive
Board consideration although it was not raised during the adoption of the
agenda. When the revised version of the resolution was finally considered
at the Assembly in May several high income members states protested at the
failure to introduce the resolution for consideration by the Executive
Board.
Germany, UK and Hungary claimed it had been rushed and should have gone
through the EB and dissociated themselves from the resolution as adopted.
Germany complained that the confidentiality of the negotiations around the
proposed resolution had been breached. The German delegation was
particularly upset by the reaction in Germany to a leak to the effect that,
“a group of Northern European countries, led by Germany, Denmark, Sweden
and the UK, plus Australia, led an effort to gut the resolution” (as
reported by KEI).
Brazil supported by Spain, Burundi and Portugal, rejected the allegation of
lack of time and failure to go through EB.
It has been suggested that the opposition of the UK and Germany was due to
the large discounts that they are able to extract from the pharmaceutical
companies through their national pharmaceutical procurement programs
(involving a single purchaser and huge volumes). Presumably the pharma
companies had advised the UK and Germany that those large discounts would
be jeopardised if all countries were able to bargain on the basis of
published net prices (net of discounts).
In sharp contrast to the opposition of the UK, Hungary and Germany, the USA
was enthusiastic in its support for the resolution as finally adopted
(after successfully weakening the reference to clinical trial costs during
the negotiations). The US Medicare is by law not allowed to negotiate
prices with pharma and pays very high prices. The Trump administration
claims that the US tax payer / enrollee subsidises access to medicines (and
the cost of innovation) for the rest of the world through the high prices
prevailing in the US.
It may be that Italy and its supporters judged that the opposition of
certain high income countries might have been more effective in the
Executive Board than in the informal and formal negotiations which led to
the final resolution as adopted.
The Portuguese intervention in support of the resolution reflects the
position adopted by many speakers.
*The very high price of some medicines and vaccines remains one of the main
barriers in this regard. We are fully convinced that the existence of
transparency in the markets for medicines would be a decisive factor to
improve access to medicines and thus contribute to universal health
coverage and to the realization of the human right to health.*
*As the Minister of Health of Portugal stated last week at a side-event in
this Assembly, “transparency is a fundamental value of modern, open and
democratic societies. However, lack of transparency prevails throughout the
pharmaceutical value chain. (…) We need to know how costly R&D is in order
to understand how fairly or not is it being reflected in the final price of
the medicine, especially in the cases where R&D is financed or conducted by
the State; this is a matter of good governance, of respect for tax payer’s
money and ultimately of respect for human rights”.*
*This is why Portugal decided to join, from the very beginning, the
core-group of countries responsible for the presentation of the draft
resolution on improving the transparency of markets for medicines, vaccines
and other health-related technologies. Quoting again the Minister of Health
of Portugal, “we believe that it can represent a step forward in
pragmatically addressing this issue since it stimulates the sharing of
international information which is essential to achieve enhanced
transparency, notably the dissemination of the results and costs of human
subject clinical trials and generic product policies. (…) Countries have to
continue to collaborate between themselves and pursue the ultimate goal of
defending the public interest. The current situation where we have to wait
for the industry, where we are bound to confidential agreements, where
companies select preferences needs to change”.*
*To conclude, promoting transparency throughout the value chain,
strengthening pricing policies, cross-sector and cross-border collaboration
for information-sharing, regulation and joint assessment and procurement of
medicines are paramount to enhance affordability and accessibility of
medicines allowing at the same time real innovation in this area.*
*Access to quality, safe and affordable medicines has to be seen from a
human rights and public health lens since it constitutes an essential
element of universal health coverage and of the right to health. WHO has an
essential role to play in this regard by helping and guiding States to
address the existing obstacles to access to medicines. *
Many other member states made similar comments. Thailand argued that
separating R&D expenditure from price setting was necessary to ensure fair
pricing and expressed concern that ‘some countries’ act as if they are
representing the interests of the drug companies, not the people.
However, the International Federation of Pharmaceutical Manufacturers and
Associations
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=cd90feeba7&e=916df65fd1>
was not happy.
*… we are concerned that some proposals in the Roadmap and at this Assembly
focusing on transparency and IP would deter from holistic and sustainable
solutions to access.*
*Long-term solutions to access challenges must promote sustained
investments in health systems strengthening, together with an innovation
ecosystem that incentivises research in new products - the generics of
tomorrow. Strong IP protection is a key component of such ecosystem, and
WHO’s activities in the area should support the private sector’s vibrant
pipeline to address today’s unmet medical needs.*
*We have heard the concerns raised regarding transparency and understand
the call for more information about our scientifically complex, and
high-risk business model […].*
*We urge MS to carefully consider potential risks to patients, particularly
in less developed countries, of sharing outcomes of confidential prices
negotiations. We also caution against disclosure requirements on R&D costs
that underscore “cost-plus” models. Prices should reflect the therapeutic
value of a medicines and positive outcomes to society, rather than simply
the cost “input” of a medicine.*
Médecins Sans Frontières
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=82185ecee3&e=916df65fd1>,
in contrast welcomed the Roadmap and the resolution:
*Exorbitant medicine prices limit MSF’s ability to provide the best
possible treatment for people in our care. The same holds true for
governments represented here today. This week, Member States are
negotiating an important resolution on medicines transparency – covering
four areas where full transparency is urgently needed: R&D costs, clinical
trial results, medicines patents, and the real prices of medicines.*
*This resolution could help save lives by setting strong norms and
standards to help correct the unacceptable power imbalance that exists
between those who need and purchase medicines – and those who produce and
sell them.*
*Pharmaceutical corporations do not set medicine prices with the objective
of ensuring access for all people in need. They set them in order to
maximise profit, which leads to rationing of medicines when patients and
health systems cannot afford the prices they charge. When governments sign
confidentiality agreements on prices, they give companies the upper hand in
price negotiations. But countries do not have to consent to being
blindfolded. There are no legal barriers that mandate this damaging
secrecy.*
*Transparency can help level the playing field and give governments the
information they need to negotiate fairly and responsibly for people and
their health. We ask Member States to require transparency on the prices
countries pay for medicines, the mark-ups companies charge, and companies’
production costs. And governments need to know who pays what for R&D – how
much investment is really covered by companies, and how much is
underwritten by taxpayers and non-profit groups.*
*MSF urges Member States to adopt a bold and clear resolution to set strong
standards that mandate transparency on medicine prices and R&D costs.*
17 countries spoke in favour of the final draft of the resolution in
unqualified terms (including the US, Costa Rica, Indonesia, Norway,
Botswana, South Africa, Algeria, Malta, Kenya, France, Zimbabwe, Tanzania,
Ecuador, Colombia, Peru, Mexico and Iran).
Thailand felt that the resolution was too much weakened by the compromises
reached during the drafting negotiations, particularly in relation to
‘voluntarily provided’ in operative para 1.2 which urges member states:
*to take the necessary steps, as appropriate, to support dissemination and
enhanced availability of, and access to, aggregated results data and, if
already publicly available or voluntarily provided, costs from human
subject clinical trials regardless of outcomes or whether the results will
support an application for marketing approval, while ensuring patient
confidentiality*
Knowledge Ecology International (KEI) stated that ‘Drug companies are
concerned that if the actual costs are disclosed, narratives about massive
R&D costs will be undermined, by facts, for a number of products.’ See KEI
commentary on the final resolution
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=6f0d0622fb&e=916df65fd1>
and its comparison of the sequence of drafts during the negotiations (here
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=ccb7cdede7&e=916df65fd1>
).
Member State Mechanism on Substandard and Falsified Medical Products (MSM)
Item 12.2 at WHA72 was a recurring item under which the Member State
Mechanism on Substandard and Falsified Medical Products was required to
report to the Assembly on its work over the last two years.
The Member State Mechanism (MSM) arose out of concern (arising from the IMPACT
scandal
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=d80c56cb99&e=916df65fd1>)
that WHO’s use of the term ‘counterfeit’ was being used to obscure the
difference between pharma claims that their IP was being infringed and
public health concerns about the circulation of substandard, non-approved
and falsified medicines. See Tracker links to WHA discussions
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=e36f744271&e=916df65fd1>
since 2010 of substandard and falsified medicines. See PHM Comment on Item
12.2
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=a93aaf6d57&e=916df65fd1>
for more background on the MSM.
The purpose of the Member State Mechanism is to promote the effective
regulation of the medicines market in order to prevent the circulation of
substandard, non-approved and falsified medicines but without having regard
to IP claims.
In contrast pharma has sought to harness the statutory powers of the
national medicines regulatory authorities to protect claimed intellectual
property rights against generic competition. Conflating IP status with
questions of quality, safety and efficacy and scare-mongering around
quality and safety have been key strategies in this project.
The workplan of the Mechanism is structured around a number of ‘prioritised
activities’ including:
1. developing training materials and guidance documents for regulatory
authorities;
2. expanding the network of national focal points;
3. exploring technologies for detecting substandard products;
4. highlighting the links between promoting affordable access to
quality, safe and efficacious medicines and reducing the demand for
substandard and falsified products;
5. risk communication and awareness campaigns;
6. awareness of the work of the MSM;
7. awareness regarding the interdiction of medical products in transit;
8. distribution of substandard and falsified products via the internet.
The substance of the agenda item for WHA72 was consideration of the reports
of the sixth and seventh meetings of the MSM.
Various aspects of the work of the MSM were noted in contributions to the
debate at WHA72.
Spain, Tanzania, Russia and Thailand expressed appreciation of progress on
track and trace technologies.
Several member states highlighted the continuing need for regulatory system
strengthening, variously appreciating WHO for its contribution to such
strengthening and asking for ongoing assistance (Algeria, Iraq, Kiribati,
Zambia, Costa Rica).
Medicus Mundi International (with PHM and TWN) highlighted the importance
of the work on transit:
*there should not be any interception of movement of medicines in transit
without the request from the regulatory authorities of either export or
importing country. The interception in the name of checking movement of
substandard or falsified will result in the interception of generic
medicines and compromises access.*
Two NSAs highlighted the link between prices and the circulation of
substandard and falsified products.
The International Association for Hospice and Palliative Care said:
*The trade in falsified medicine flourishes in the shadow of unmet health
needs. All over the world people are seeking help to cure infectious
diseases or to ease acute untreated pain. In the absence of bona fide
health services they turn to informal providers who are poorly qualified
and insufficiently motivated to properly assess the quality of the
medicines they supply. While we strongly support the strengthening of
measures to address the production and trade in falsified and substandard
medicines and call on all member states to sign up to the Medicrime
Convention, we also contend that looking for scapegoats does not bring us
further. It ends up by turning public health into an arm of law enforcement
and runs the risk of criminalizing the very people our health care has
failed to serve.*
MMI (with PHM and TWN) recalled that
*… in 2014 MSM called on the Secretariat to provide a Study to deepen
understanding of the link between access to quality, safe, efficacious and
affordable medical products and the emergence of substandard and falsified
medical products. However, there is no progress in concluding the study. We
would like to stress that access to medicines can eliminate the incentive
for the circulation of falsified medicines.*
MMI (with PHM and TWN) were particularly critical of the participation of
WHO in the conflation of substandard and falsified as one phenomenon:
*… even after the finalization of definitions WHO continues to conflate
substandard and falsified medicines. Instead of giving separate data on the
circulation of substandard and falsified medicine, the Secretariat provides
aggregate data of substandard and falsified. This approach is not only
erroneous but also helps the scaremongering on quality of medicines.*
This statement appears to be referring to WHO’s 2017 study on the public
health and socioeconomic impact of substandard and falsified medical
products
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=47d946befa&e=916df65fd1>
(funded by the US FDA) which provides aggregate data regarding the
incidence of “substandard *and* falsified” samples with no attempt to
distinguish between the two. In fact as the report notes, three different
categories have been recognised and defined by WHO in Decision WHA70(21)
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=923c169ecc&e=916df65fd1>
as presented by the MSM in Appendix 3 to Annex, A70/23
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=92a936637d&e=916df65fd1>,
(2017). These are:
*Substandard medical products.* Also called “out of specification”, these
are authorized medical products that fail to meet either their quality
standards or their specifications, or both.
*Unregistered/unlicensed medical products*. Medical products that have not
undergone evaluation and/or approval by the national or regional regulatory
authority for the market in which they are marketed/distributed or used,
subject to permitted conditions under national or regional regulation and
legislation.
*Falsified medical products*. Medical products that
deliberately/fraudulently misrepresent their identity, composition or
source.
Not only was the study funded by the US FDA but the largest single source
of data was the US Pharmacopeia Medicines Quality Database (MQDB). The MQDB
reports samples as ‘pass’ or ‘fail’ in relation to the method of testing
but does not provide a breakdown in relation to these three categories.
Clearly these three categories have different causes and call for different
responses. The MMI/PHM/TWN statement comments that this lumping together
‘helps the scaremongering on quality of medicines’.
The charge of scaremongering gains in credibility from the gaggle of
non-state actors whose statements to WHA72 highlighted the Fight the Fakes
Campaign whose partners include the IFPMA and a number of companies and
other industry bodies. The NSAs celebrating the Fight the Fakes campaign
included the International Council of Nurses, the International
Pharmaceutical Federation and the International Pharmaceutical Students’
Federation all of whom are partners of the campaign. Clearly falsified
medicines are fakes but substandard and unlicensed products present
different problems. It would appear that the Fight the Fakes Campaign is
deliberately conflating the three categories listed above under the
‘falsified’ category. Whether the ‘partners’ understand how they are being
used is not clear. It looks like scaremongering.
PHM Comment
Affordable access to appropriately used, good quality, safe and efficacious
medicines is a huge public health challenge.
Price barriers to procuring necessary medicines prevent many families from
accessing treatment and prevent many governments from providing decent
health care to their people. UHC means nothing if people cannot afford
medicines.
WHO (2018)
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=6eceeb36d6&e=916df65fd1>
reports that in 2010, an estimated 808 million people – 11.7% of the
world’s population – spent at least 10% of their household budget paying
out of their own pocket for health services. An estimated 97 million people
were impoverished by out-of-pocket health-care spending in 2010.
WHO (2015)
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=7effede43c&e=916df65fd1>
reports that medicines account for 20–60% of health spending in low- and
middle-income countries, compared with 18% in countries of the OECD. Up to
90% of the population in developing countries purchase medicines through
out-of-pocket payments, making medicines the largest family expenditure
item after food.
Drug price surveys in L&MICs (Cameron and colleagues 2008
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=26eeb514e5&e=916df65fd1>)
found that private sector patients paid 9–25 times international reference
prices for lowest-priced generic products and over 20 times international
reference prices for originator products across WHO regions.
The following extracts provide an indication of the disease burden arising
from lack of affordable access.
- An estimated 940 000 people died of HIV-related illnesses in 2017, 110
000 of whom were children. However, 41% of people living with HIV were
still not receiving treatment. (A72/11 Rev.1
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=2befb0bf99&e=916df65fd1>
)
- Progress on malaria has stalled with 435,000 deaths in 2017. There
were an estimated 3.5 million more malaria cases in the 10 highest burden
African countries in 2017 compared with the previous year. (A72/11 Rev.1
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=a10406f10d&e=916df65fd1>
)
- Globally, an estimated 71 million people have chronic hepatitis C
virus infection. A significant number of those who are chronically infected
will develop cirrhosis or liver cancer. WHO estimated that in 2016,
approximately 399 000 people died from hepatitis C, mostly from cirrhosis
and hepatocellular carcinoma (primary liver cancer). Antiviral medicines
can cure more than 95% of persons with hepatitis C infection, thereby
reducing the risk of death from cirrhosis and liver cancer, but access to
diagnosis and treatment is low. A record 3 million people accessed
treatment in 2016 and 2017. (WHO hepatitis page 2019
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=e352aa9ef2&e=916df65fd1>
)
The shortfalls reported are multifactorial, including, in particular, weak
health systems. However, it is undeniable the cost of medicines is a major
factor.
The three debates at WHA72 reported above illustrate the technical
complexity of the issues as well as the corporate and political forces at
play.
The Roadmap debate highlighted the role of intellectual property (IP)
protection in keeping prices high and the significance of the
R&D expenditure argument in defending this regime. The transparency debate
highlighted the significance of secrecy in keeping prices high (for some)
and the critical importance, for pharma, of keeping secret the real costs
of R&D. The substandard and falsified debate highlighted conflicts over
regulatory purpose and role of scaremongering in protecting originator
drugs from generic competition.
The adoption of the transparency resolution (albeit somewhat watered down)
shows that pharma and its nation state representatives are not all
powerful. In this case they have been defeated by a combination of good
technical people in the UN system (including WHO and UNDP); an alliance of
governments, largely from low and middle income countries, and a network of
progressive civil society organisations. The forces behind the Secretary
General’s High Level Panel included UNDP, UNAIDS and the international AIDS
movement.
Ongoing research and advocacy at all levels has been critical in this
confrontation. Behind the diplomatic engagements, for pharma and its
allies, is the threat of delegitimation; the prospect of the whole system
coming into question. The leadership role of the AIDS movement around
access reflects the significance of popular mobilization in driving such
change. The burden of health care costs more generally and the role of
medicines in this burden points to the possibility of this movement having
a determining influence on access.
Working with other organisations and networks, the People’s Health Movement
will continue to research and share the technical and the political
dimensions of this confrontation; we will continue to advocate and mobilise
among the communities whose health care is at stake; and we will continue
to promote that Another World is Possible.
More
For full coverage of the WHA consideration of access to medicines see the PHM
item page
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=ca9d871c99&e=916df65fd1>.
The PHM item page for the Member State Mechanism debate, is here
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=0bf9386c2d&e=916df65fd1>.
Each item page includes: summary of issues in focus at the Assembly;
background notes; PHM commentary and the WHO watchers' notes of the debate.
Access all of the documents and debates from the World Health Assembly from
the WHO Tracker at who-track.phmovement.org/wha72
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=bb42948a7e&e=916df65fd1>.
Review previous Update Reports from WHA72 here
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=3cbdf8763a&e=916df65fd1>
.
Spread the word
The purpose of WHO Watch is to contribute to democratising global health
governance, through new alliances and new information flows. You can help
by forwarding our updates, disseminating on social media and inviting
others to subscribe to the Updater
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=ddc71435c4&e=916df65fd1>
.
WHO Watch is a project of the People's Health Movement
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=25d260aa1f&e=916df65fd1>
in cooperation with Medicus Mundi International
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=0ab87ab66d&e=916df65fd1>,
Third World Network
<https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=71defe6bc9&e=916df65fd1>
and a number of other civil society networks.
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