C Explanatory memorandum
by Ms Jennifer De Temmerman, rapporteur
1 Introduction
1. The Covid-19 pandemic has highlighted
the need to address the vulnerabilities of global medical supply chains.
During this crisis and in particular in the early stages of it,
shortages of medical products increased dramatically. Market conditions
for supplies were impacted in an unprecedented way. Stockpiling,
restrictions on exports, closed borders and lockdowns led to shortages
of essential medicines in many member States. Concerns were also
raised as to whether the products that reached European markets
in the early stages of the pandemic met the necessary standards
for quality and safety.
2. Shortages in medicines and medical products happen regularly
and a multitude of factors are to blame. There are typically a number
of combined causes that create situations during which the demand
for a medicine cannot be met by an adequate supply. In order to
secure supply chains and make them more resilient it is thus important
to study and understand the underlying causes of disruptions. I
would like to pay tribute to the work of my French colleague, Senator
Jean-Pierre Decool, the author of an information report on the shortage
of medicines and vaccines in 2018.
Note In this report it was noted that
the solution to this problem could not be drawn solely from the
legal field and that the real issue was a medicine industry whose
main concern was to contain costs.
3. The Council of Europe has a role to play in preventing and
combating this phenomenon. Its response to the Covid-19 pandemic
was swift on the whole, providing its member States with tools and
expertise to ensure that our shared values and principles were not
undermined by the crisis. The Secretary General
Note called on the member
States to introduce co-ordinated policies taking a human rights-based
approach, including through the European Convention on Human Rights
(ETS No. 5), the European Social Charter (ETS No. 35), the Convention
on Human Rights and Biomedicine (ETS No. 164, “Oviedo Convention”),
the Convention on the Elaboration of a European pharmacopoeia (ETS
No. 50) and the Convention on the counterfeiting of medical products
and similar crimes involving threats to public health (CETS No.
211, the “MEDICRIME Convention”).
4. On 3 December 2020, the Committee on Social Affairs, Health
and Sustainable Development tabled a motion for a resolution
Note entitled “Securing safe medical
supply chains”. This initiative came following a public hearing
on this topic held by the Sub-Committee on Public Health and Sustainable
Development on 7 October 2020 with the participation of Ms Nathalie
Colin-Oesterlé, Member of the European Parliament (France, EPP/CD);
Mr Thomas Senderovitz, Director General of the Danish Medicines
Agency; Ms Susanne Keitel, Director, European Directorate for the
Quality of Medicines & HealthCare (EDQM); Mr Sergei Glagolev
(Russian Federation), Chairperson of the Committee of the Parties
of the Council of Europe MEDICRIME Convention; and Mr Allal Amraoui,
member of the Moroccan partner for democracy delegation to the Parliamentary Assembly.
5. The hearing was broken up into two sessions. The first session
focused on how to build resilience to future crises by making the
medical supply chains more sustainable while ensuring that they
meet the requirements of safety and quality. The second part of
the hearing was dedicated to the MEDICRIME Convention and possible
ways to prevent counterfeit medical products (namely, medicinal
products and medical devices) from entering the supply chains.
Note
6. The motion for a resolution proposed that the Assembly look
into how to strengthen the medical supply chains to ensure an uninterrupted
supply of essential medicines, medical devices and other health
products that are safe and meet standards for efficacy or performance.
Moreover, the motion invited the member States to step up action
to prevent falsified medical products from entering the supply chains,
and ratify the MEDICRIME Convention as soon as possible. The motion
was referred to our committee for report and I was appointed rapporteur
on 16 March 2021.
2 The causes of supply chain disruption
7. The Covid-19 pandemic has destabilised
all goods supply chains and has been a factor in reigniting inflation
which is now impacting household budgets through price rises and
shortages of varying durations. The war in Ukraine will bring with
it even more damaging consequences, entailing substantial rises
in prices of energy and essential goods. In the health sector, this
succession of crises has exacerbated the disruptions to medical
supply chains that were already known prior to it. On top of people
being made poorer, their right to protection of health is also in
jeopardy, including the right to equitable access to appropriate
quality healthcare.
8. The scope of this report is not limited to the supply of retail
pharmaceuticals which, according to the OECD,
Note account for a substantial share
of health spending (one‑sixth of overall health expenditure).
Note It covers the entire supply chain,
including pharmaceuticals used in hospitals and clinics whose prices
have shown a particularly marked increase partly because of their
highly technical nature. These price issues have ramifications for
solidarity-based national health systems and threaten their financial
balance. In OECD countries, the bulk of health costs is covered
by compulsory health insurance and government spending (56%). This
figure reaches more than 80% in countries such as Germany and France.
The consumption of medicines has risen strongly in recent decades
as a consequence of populations growing older and higher living
standard. Consumption of anti-hypertensive drugs has increased by
65% since 2000, nearly quadrupling in Estonia. The use of other
drugs such as antidiabetic medications or antidepressants has also
grown dramatically. That said, generic drugs account for 24% of
the entire pharmacy market by value and 53% by volume. The pharmaceuticals
sector represents 13% of all research and development, which is
as much as the aeronautical sector. In 2020, the American Food and
Drugs Administration registered 43 new pharmaceuticals, and the average
for recent years is around 50. The Covid-19 pandemic does not appear
to have halted the steady growth in the consumption of pharmaceuticals.
9. This report follows up the discussion launched by
Resolution 2071 (2015) “Public health and the interests of the pharmaceutical
industry: how to guarantee the primacy of public health interests?”
in which the Assembly spoke out about the increase in the number
of new medicines marketed without a real therapeutic benefit or
satisfying genuine health needs. Beyond the aspect of pharmaceutical
development, it is also the supply chain which is problematic and
affects the resilience of health services.
10. A key factor which leads to disruption of medical supply chains
is the limited number of production sites that supply the world
with the active substances (also known as Active Pharmaceutical
Ingredients – APIs) used in medicines, which for generic medicines
with low profit margins come from low- and middle-income countries.
Many products are formulated and packed or repacked in other third
countries. Experts have pointed out that it is likely that the world
will soon be fully dependent on India and China as main API manufacturers, and
are also significantly involved in the manufacturing of generic
medicines and biosimilars. Additionally, there are indicators that
more third countries could become players in the global supply chain.
11. This is a trend that we have seen for more than 25 years,
as production sites have been closed or moved out of Europe – often
in order to reduce costs. For example, the last production site
for paracetamol in Europe, located in France, discontinued its production
in 2008.
Note Since then, all active substance
of paracetamol entering into the European market comes from outside
our continent. Likewise, most medicinal products such as antibiotics
and most vaccines are produced outside European borders. Thus, the
globalisation of supply chains has made regional and international
co-operation even more necessary. European manufacturing has specialised
in more advanced products with higher added value. Industrial actors
have often opted for narrower specialisations, abandoning whole
swathes of their traditional business. By way of illustration of
this trend, according to the pharmaceutical industry, even after
the succession of numerous mergers and acquisitions in 2020, the
five leading players in the sector accounted for only 22% of the
global market.
12. In November 2020, the French consumers association UFC/Que
choisir
Note published an alarming survey, drawing
the attention of the authorities to the problem of shortages of
pharmaceuticals. Compared to 2016, when the authority responsible
for supervising the market recorded 405 shortages or possible risks
of shortages, there were 2 400 in 2020. It highlighted the poor
alternatives to the pharmaceuticals in short supply, but above all
the fact that 12% of manufacturers were pushing health professionals
towards lower dosages or, in 18% of cases, offered no solution at
all, which risked leaving patients completely stranded. The survey revealed
that the breakdown of supply related above all to medicines that
had been on the market for many years and were cheap and preferred
by users. In 2020 and 2021, the French national agency for the safety
of medicines and health products (ANSM) and the French association
for the prevention of allergies regularly alerted patients and professionals
that adrenaline pens were in short supply and recommended that they
hang on to their pens until the expiry date before getting new ones
from the chemist.
Note Similar shortages affected the
United States, the United Kingdom and Australia. It stemmed from
the difficulties encountered by the manufacturer of the world's
most commonly prescribed treatment in its one and only factory near
Saint Louis (Missouri) in the United States. Associations of patients
welcomed the fact that direct competitors stepped in to make up
the shortfall in supplies.
Note At the time of writing this report,
supplies of Spasfon, a symptomatic treatment used against functional
disorders of the digestive tract, widely used by women to treat
painful digestive tract spasms of gynaecological origin, had been
disrupted in France for the last eight weeks. Supply chain malfunctions
give rise to inequalities, often gender-linked, affecting people
who need care. The United Kingdom is also currently experiencing
severe disruptions to the supply of hormonal replacement therapy
drugs for one million premenopausal women.
Note
13. The causes of shortages also include structural weaknesses
in the supply chain. The British National Pharmacy Association (NPA)
Note thus deplores the quota system applied
by some manufacturers to control the European market and the excessive
stocks required by certain wholesalers. Patients' access to treatment
is delayed, if not impossible.
14. To tackle supply shortage issues, the NPA: co-operates with
the health authorities to ensure the supply of medicines to pharmacies
within 24 hours; protects the reputation of pharmacies by countering
misleading media reports, commissioning independent research into
the medicine shortage problem and its impact on patients; provides
advice to its members on how to deal with medicine shortages; raises
their concerns through international bodies; promotes the capability
to trade stock between pharmacies, lobbies MPs on this problem; and
contributes to dialogue with national authorities, wholesalers and
manufacturers. It has made a “toolkit” available to its members.
15. The UK body promoting the interests of the National Health
Service community pharmacists
Note has revealed, in survey findings
published on 25 April 2022, that pressures on pharmacists are strongly
impacting teams, business and patients. Pharmacists are now experiencing
shortages of staff, who had to work very long hours during the pandemic.
There has been a huge rise in the number of staff off sick. The
mental health and well-being of pharmacists and pharmacy teams have
suffered. They can no longer spend the necessary time with patients,
they deplore the fact that prescriptions now take longer to dispense
and are unable to provide new services. They are also increasingly
exposed to abuse from patients who are angry about supply shortages.
Note
16. As argued during the hearing on 7 October 2020, in the short-
and mid-term, supply chains can be made more resilient through a
co-ordinated approach between stakeholders. In the mid- to long-term
a diversification of API production across different global regions
is a critical factor to increase the resilience of supply chains. Evidently,
being overly reliant on one country or one region makes supply chains
vulnerable to disruptions. Following the public health crisis and
the disruptions in medical supply chains that were sparked by the
Covid-19 pandemic, pharmaceutical company Seqens is set to start
its production of paracetamol as of 2023 in Roussillon in Isère,
France.
Note
17. Commercial interests and the choice of supply chain management
methods, such as just-in-time production, are other factors that
make supply chains more vulnerable to disruptions and thus impact
the availability of life saving medicines and medical products.
A way to strengthen medical supply chains could be to only buy medical
products from companies that can demonstrate that their supply chain
is resilient to a variety of shocks, including by not being overly
reliant on one country or region.
Note In the report on “Public health and
the interests of the pharmaceutical industry: how to guarantee the
primacy of public health interests?” our former colleague Ms Liliane
Maury Pasquier (Switzerland, SOC) pointed out that measures should
be taken with a view to gearing the pharmaceutical industry system
to public health needs, including by adopting stricter marketing
authorisation policies and by ensuring full transparency regarding
the real costs of research and development.
Note
18. Globalised supply chains and markets underline the need to
optimise supervisory oversight, especially for the manufacturing
of active substances, through international co-operation and collaboration
based on both new and already existing initiatives, such as with
the EDQM. Efforts should be focused on gathering more data on supply
chain risks and embedding deeper regulatory co-operation with key
countries. More detailed studies looking into the vulnerabilities
in supply chains are necessary in order to have a better understanding
of the actions needed to avoid future disruptions. Increased regulatory
co-operation with pharmaceutical producers is also needed so as
to ensure that products imported during an emergency situation meet
safety and quality standards, as was rightly done at the beginning
of the Covid-19 pandemic.
19. The EDQM, a directorate of the Council of Europe, plays a
significant role in protecting public health in Europe and beyond,
and ensuring the safety of medical supply chains. It does so by
enabling the development, supporting the implementation, and monitoring
the application of quality standards for safe medicines and their safe
use. At the beginning of the pandemic, the EDQM introduced its business
continuity plan to anticipate and mitigate any risks of disruption
to its activities, so that the standards necessary for the production
and release of medicines by pharmaceutical manufacturers and for
market surveillance testing by Official Medicines Control Laboratories
remained available. Additionally, the EDQM compiled a list of substances
that are used in intensive care units and in clinical trials that
they constantly monitor to avoid any disruption,
Note as well as information on products
and extemporaneous preparations of paediatric formulations that
may be useful in the treatment of Covid-19.
Note Over 80 % of the active ingredients
used in the preparation of the medicines available in Europe are
produced outside Europe and the United States. The EDQM ensures
the good quality of medicines in all the States parties to this
Council of Europe partial agreement. On this basis, it guarantees
that branded medicines and generic medicines sold in any of the
countries covered by the partial agreement will be of the same quality.
20. In response to the lessons to be learned from the Covid-19
pandemic and as a deliverable for 2025, the EDQM is to prepare a
Methodological guide for selecting medicines at risk of shortage
during public health emergencies, providing guidance on how to address
these shortages via the optional and temporary use of standardised
pharmacy preparations in hospital and community pharmacy settings.
This publication is part of the terms of reference of the European
Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH), which
is one of the EDQM's steering committees. It provides support to
authorities for dealing with the challenges of making the medication
process safer, more responsible, and accessible to all who need
it, at a time of ever greater social gaps and financial constraints.
It is tasked with defining strategies to minimise the impact of
shortages of medicines during public health emergencies with a view
to ensuring continuity of care and safeguarding timely access to
safe and effective quality medicines.
21. The European Medicines Agency (EMA) together with the Heads
of Medicines Agencies (HMA) have since 2016 provided strategic support
and advice to tackle disruptions in medical supply of human and veterinary
medicines and ensure their continued availability.
Note The key priorities of the HMA/EMA
Task Force include looking at ways to minimise supply disruptions
and avoid shortages by facilitating approval and marketing of medicines
using the existing regulatory framework; developing strategies to
improve prevention and management of shortages caused by disruptions
in the supply chains; encouraging best practices within the pharmaceutical
industry to prevent shortage; improving sharing of information and
best practices among EU regulatory authorities to better co-ordinate
actions across the European Union; and fostering collaboration with
various stakeholders and enhancing communication of supply problems
to EU citizens.
Note
22. Many have pointed out that the European Union should expand
its stockpile of medical equipment. At the Council of Europe, we
need to think bigger, as our Organisation includes 19 member States
from outside the European Union. Furthermore, an important lesson
from the pandemic is that nobody is safe until everyone is safe.
Medical shortages in other parts of the world could consequently
have a negative impact on our continent as well. Member States should
therefore support the World Health Organization (WHO) in maintaining
global stockpiles. This would enable the release of essential medical
supply to those countries that need it the most and their fair and
efficient distribution.
23. Counterfeit medical products are another danger to public
health and can violate the right to life enshrined in the European
Convention on Human Rights, the right to protection of health, enshrined
in the European Social Charter, and the right to equitable access
to healthcare of an appropriate quality enshrined in Article 3 of
the Oviedo Convention. As the supply was outstripped by demand,
in particular at the beginning of the Covid-19 pandemic, concerns
were raised over counterfeiting of medicines and medical products,
and existing pressures and risk of corruption on procurement were
amplified.
24. The Covid-19 pandemic has also destabilised the illegal drugs
market. British experts have expressed alarm over the risk of some
heroin users turning to Fentanyl,
Note an opioid analgesic medication which
is 50 to 100 times stronger. I refer the reader in this connection
to the work by our colleague Mr Joseph O’Reilly and
Resolution 2335 (2020) “Drug policy and human rights in Europe: a baseline
study”.
25. Finally, the Covid-19 pandemic has also put pressure on veterinary
medicines, to the point of endangering not only animals but above
all humans. Shortages of Ivermectin,
Note one of the world's most widely used
deworming drugs in veterinary care, have bumped up the price of
treatments meant for animals. The hopes raised by a study in a lab
setting that did not involve humans took a nightmarish turn when
people were hospitalised with major complications brought on by
self-medication.
3 Making medical supply chains more
efficient and resilient
26. Under the MEDICRIME Convention,
intentionally manufacturing, supplying, offering to supply, and trafficking
of counterfeit medical products is considered a criminal act. This
convention was the first and is currently the only binding international
instrument in the criminal law field on the counterfeiting of medical products
and similar crimes involving threats to public health. This innovative
treaty calls for multilateral collaboration across nations, disciplines,
and sectors, and lays the groundwork for co-operation with and between
international bodies such as the International Criminal Police Organization
(INTERPOL), the European Union Agency for Law Enforcement Cooperation
(Europol), the United Nations Office on Drugs and Crime (UNODC),
the World Customs Organization (WCO) and WHO, in order to put a
stop to this international threat to public health. This multilateral
co-operation approach is also taken within the Council of Europe
with the work programme run with health regulatory authorities of
the 39 States parties to the Convention on the elaboration of a
European Pharmacopoeia gathered in the intergovernmental Committee
of Experts on Minimising the Public Health Risks Posed by Falsification
of Medical Products and Related Crimes (CD-P-PH/CMED). This committee
also raised the alert over the increasing risks of falsification
created by shortages of medicinal products and medical devices.
Note Only 13 member States and 6 non-member
States have ratified the MEDICRIME Convention. This innovative instrument
deserves the parliamentarians' support to boost its sphere of influence.
27. At its plenary meeting held in May 2021, the MEDICRIME Committee
took note that a working group had been set up to draft a report
on criminal activity resulting in leakages in the medical product
supply chain. The working group is composed,
inter
alia, of police authorities, Europol and the European
Anti-Fraud Office (OLAF).
NoteNote It has also
adopted two key documents: the Advice of the Committee of the Parties
of 8 April 2020 on the application of the MEDICRIME Convention in
the context of Covid-19
Note and the Advice of 27 April 2021 on
the application of the MEDICRIME Convention in the context of counterfeit
Note Covid-19 vaccines, and notably the explanatory
report thereto.
Note
28. One of the weaknesses observed in the sector lies in its actual
functioning and the allowance made by professionals for entropy,
namely, the ability to cater for uncertainty, which is exactly what
characterises the state of disorder in a system. The decision-making
process for clinical testing should, as far as possible, be evidence-based,
which means mobilising concerted efforts at the level of biologists,
practitioners and care staff, but there is often a lack of sufficient
evidence to overcome uncertainty. Medicine remains both an art and
a science. In an article which is already two decades old, the clinicians
Isaacs and Fitzgerald
Note sought
to analyse the essence of their profession, noting that, in the
absence of sufficient evidence, no decision was a clear winner.
Medicine could be eminence-based when more senior colleagues benefiting
from the “halo effect” could make mistakes over the years with increasing
confidence. There is also vehemence-based medicine where the substitution
of volume for evidence is an effective technique for convincing
more timorous colleagues. Eloquence-based medicine distracts from
the need for evidence, while diffidence-based medicine does not
look for an answer to a problem but merely sees a problem. Finally,
nervousness-based medicine merely responds to a stimulus, generating
ever more hesitation, over-investigation, and over-treatment. In conclusion,
the authors stress the need to forge deep levels of confidence between
the players in the sector. And without confidence, there must be
no lack of transparency in a system where science does not provide
the right answers. In addition to the information passed on by pharmaceutical
companies, we should note the importance of peer review and the
decisive contributions of the European Pharmacopoeia and Cochrane organisation.
29. Since 1974 the European Pharmacopoeia
Note has made a regulatory contribution
to the protection of public health through the development of recognised
common specifications relating to the quality of medicinal products
and their components. It is a unique reference for the quality control
of medicines in the countries that have signed up to the convention
underlying it. Together with the European Pharmacopoeia, the US Pharmacopoeia
and the Japanese Pharmacopoeia form the three works of reference
making up the integrated international system of standards harmonisation.
Other pharmacopoeias, although they do not have the same legal status,
are published by different States around the world (Brazil, India,
China, etc.).
30. Since 1983, the UK-based not-for-profit organisation Cochrane
has succeeded in forging a network extending across more than 220 countries
and territories, bringing together researchers, health professionals, patients,
carers, and other people passionate about improving health outcomes
for everyone, everywhere, based on evidence from clinical testing.
In this connection, it promotes transparency in the medical supply chain.
Its goals
Note are to: produce trusted evidence;
advocate for evidence and; inform health and care decisions. It
publishes public statements on the Cochrane community website.
Note “Cochrane strongly supports efforts
to ensure the availability of data from all clinical trials. To
assess the effectiveness and safety of healthcare interventions,
we need to know what trials were done, how they were conducted and
what their findings were.”
Note
31. The question of medicinal sovereignty has returned to the
forefront of national debates. The idea that supply chains can dry
up as a result of logistical problems on the other side of the world,
as was the case during the health crisis and could continue to be
the case owing to the war in Ukraine, calls for an industrial policy response
from the authorities for the entire supply chain, from precursors
to essential medicines. The climate crisis, entailing higher transport
costs that impact end users and the balance of health systems, is
a further reason for reviewing how the sector is organised.
32. A recent study funded by the TEVA pharmaceuticals group
Note shows that patients attach increasing importance
to the origin of medicines, in the same way that they want to know
where their food comes from. They care more about where their drugs
are made, and 71% of them want to see Europe remain as competitive as
other regions in the production of medication for chronic conditions.
They are also concerned that every region around the world should
have equitable access to vital medicines.
33. Under arrangements for co-operation with WHO, the EMA can
provide scientific opinions on a number of high priority human medicines,
including vaccines. This procedure is known as
EU-M4allNote and is not linked solely to the
Covid-19 pandemic. It has existed, previously under another name,
since 2004. The programme makes it possible to share rigorous scientific
assessment by EMA experts, in collaboration with those of WHO and
the target country. It cuts down on duplication of efforts, provides
a means of sharing EU methodologies, takes account of the benefits
and risks for a population outside the European Union, strengthens pharmacovigilance
capabilities and facilitates marketing authorisations in target
countries.
34. At the 2014 Global Forum on Competition, the OECD
Note noted the following lessons where
distribution of pharmaceuticals was concerned: health policy makers
and enforcers need to understand the distinctive features of the
sector thoroughly to be able to intervene in it; the enforcement
of the regulation over the incentives provided by manufacturers
to doctors should be improved; mechanisms used to regulate prices must
comply with the rules laid down by the competition authorities;
generics must be given a stronger role; integration by manufacturers
and pharmacy must be supervised; and finally the specific characteristics
of national organisations must be respected.
4 Making strong codes of ethics a formal
requirement from development onwards, right up to the end user
35. In the United States, the Martin
Shkreli case shook public opinion. This former hedge fund manager made
the headlines with his handling of the US sales of the Daraprim,
an antiparasitic drug on WHO’s list of essential medicines, hiking
its price from 13.50 to 750 dollars in 2015. In January 2022 he
was convicted of practising a monopoly and banned for life from
the health sector.
Note He is currently serving a seven-year
prison sentence. In 2011, President Obama
Note demanded that the Food and Drug Administration
(FDA) directly communicate to the Department of Justice any findings
proving market manipulation or collusion. Crude manipulation of
this kind should not be possible.
36. The opioids crisis has been another feature of this controversial
sector. Their consumption, whether prescribed or bought illegally,
has sky-rocketed in some OECD countries to the extent of causing
addictions and deaths by overdose, not to mention social and economic
consequences.
Note Their low cost made them attractive,
but their use has had damaging effects on the health of patients
who have failed to comply with dosage levels. Their effects have
served as a reminder of just how much the health sector remains
a risk sector for the whole of society. Any wrong step can have
serious public health implications but above all it can be capitalised
on by organised crime. This crisis underlined that professionals
were lacking in continued training on the effects of certain treatments
and that they had a responsibility for prevention and market organisation.
37. While the Covid-19 pandemic provided an opportunity to restore
confidence in vaccines, it has done nothing to alleviate patients’
suspicions regarding the pharmaceutical industry
.Note The sector remains particularly
exposed to structural weaknesses and the risks of corruption, whether
at the level of manufacturing or the supply of medical products
to end users. The question of ethics codes for professionals in
the medicines sector requires efforts on the part of those professionals
to restore public confidence. Prosecutions linked to Mediator, Levothyrox,
Dépakine, breast implants and so on are ongoing in the courts.
38. The lack of ethics of some manufacturers and distributors
has resulted in them being held criminally liable. Transparency
International sees health as one of the sectors most exposed to
corruption. In 2016, TEVA Pharmaceutical Industries received the
fifth highest fine ever imposed by the United States authorities
for corruption
Note (283.2 million US$) for bribing
public officials in Russia, Ukraine and Mexico. Novartis was convicted
twice and had to pay 347 million US$ to the American Department
of Justice and the Securities and Exchange Commission (SEC)
Note in 2020. Other groups brought to book
include Pfizer for scandals in China and Croatia, Eli Lilly for
its conduct in Poland or Sanofi in Kazakhstan and in the Middle
East, as well as AstraZeneca, Bristol-Myers, GlaxoSmithKline, Johnson
and Johnson, Schering-Plough. More recently, in July 2020, the SEC
ordered Alexion Pharmaceutical to pay a fine of 21 million US$.
Note With the rise in scandals and in
connection with Sustainable Development Goal 3 “Good health and
well-being”, Transparency has undertaken to map corruption risks
throughout the health sector, from research to care provision, and demonstrate
how procurement transparency can reduce waste and inefficiencies,
promote fairness, and strengthen health systems.
Note
39. Health Action international (HAI) deplores the constantly
escalating prices of certain molecules in Europe to the point where
the right to protection of health is endangered and views these
increases as being the direct product of a narrow interpretation
of copyright law, which paves the way for dangerous monopolies. At
the same time, it notes that some new medicines have little or no
therapeutic value compared to treatments already available. For
HAI, the necessary acceleration of the licensing procedure would
mean that there are fewer clinical trials and would create major
uncertainty as to the proven effects of treatments. Consequently,
it calls on the EU authorities to ensure fair market access for
cheap drugs. It calls for increased safety of medicines through
the promotion of the therapeutic benefits and rational use of medicines.
Finally, it seeks the democratisation of drugs policies via good
governance of the pharmaceuticals sector.
Note
40. In the United States, the SEC has pointed to the pharmaceuticals
sector as being particularly exposed to corruption risks. It encourages
whistle-blowers by offering them a substantial share of the fines
collected. The Pharmaceutical Integrity Coalition
Note helps professionals to report price
fraud involving medicines, defective equipment, problems of information
regarding medicines, misrepresentation, and licensing procedure violations.
41. We are beginning to see a sense of awareness taking hold.
The big companies in the sector have managed to introduce procedures
for strong prevention. The OECD observes that prevention efforts
are beginning to reach small and medium-sized businesses. Pharmaceutical
manufacturers and distributors have obligations in the prevention
of corruption. The OECD published due diligence guidance for responsible business
conduct
Note in 2018 so that they take social,
human rights and environmental considerations into account. In December
2019, the World Economic Forum launched the Davos Manifesto for
a stakeholders’ capitalism instead of a shareholders’ capitalism.
Note
42. Transparency France deplores the fact that the national authorities
regulating the pharmaceuticals sector in Europe do not always protect
patients’ interests.
Note Transparency is not practised in
line with undertakings, and the authorities are overwhelmed. The
reliability of the European Register of Clinical Trials is disputed
owing to missing or inaccurate information. The study carried out
expresses concern over the markedly poor performances of the French,
Italian and Dutch regulators. Those involved call for closer harmonisation
of working techniques and greater transparency for clinical trials
between European countries. They also suggest sanctions that are
enough of a deterrent for those who breach the obligation of transparency.
43. The players in the supply chains are both private-sector and
public-sector. In some cases public services are delegated to private-sector
players in some highly regulated professions (pharmacists and doctors). Confidence
in all the players must be reinforced in order not to jeopardise
overall sector balance. Following a revolving doors scandal involving
supervisory authorities and the private sector in 2011
Note, the European Medicines Agency has
introduced preventive procedures to control and limit the risks
of similar incidents.
44. At a time when several pharmaceutical companies wield more
financial power than some of the country where they are operating,
when those companies have radically changed their focus after a
period of heavy market concentration marked by the destruction of
know-how and de-industrialisation in Europe, when prices of innovative
medicines are sometimes reaching peaks, when the production of certain
essential treatments is concentrated in countries on the opposite
side of the world, and when shortages are jeopardising health and well-being,
repeated calls should be made on the sector to review how it is
organised in order to restore confidence, before sweeping changes
are demanded.
45. The climate crisis will exert an increasingly strong impact
on the supply chains. Beyond the responsibility of the manufacturers,
account must also be taken of the agents who represent the manufacturers;
the wholesalers; the dispensaries and pharmacies; and also, the
suppliers of hotel services for hospital patients as well as the
transport companies who take people to out-patient services. According
to the Shift Project,
Note the health sector accounts for between
7.5 and 8% of French carbon emissions, equivalent to 46 million
tonnes of CO2.
Note The
first carbon constraint will be to take account of climate change
as well as the increasing scarcity of energy resources. The first
of these aspects was described by our colleague, Ms Edite Estrela,
in her report “Climate crisis and rule of law”.
Note The Shift project recommends cutting
emissions linked to purchases of drugs and medical devices; cutting
emissions linked to energy consumption; taking action on transport
movements; taking action on waste; and using digital technology
to support decarbonisation, the aim being to pave the way for the
emergence of an abstemious and resilient health system.
5 Conclusions
46. Confidence is one of the pillars
of our societies. In the sphere of health, it enables care staff
to rely on their peers and other care sector players to discharge
their front-line duties. It is also important for patients, who
expect everything to be done to care for them. But in a sector that
lurches from crisis to another, the sincerity of the players involved
has to be verified. The scandals that taint them must be avoided.
The question of the effectiveness and safety of the medical supply
chains is also posed, not least because uncertainty remains despite
the willing attitude and sincere efforts of health sector players.
The right to healthcare requires a very high level of ethics to
advance general well-being.
Note The Covid-19 pandemic had a particular
impact on the resilience of the health sector, already badly affected
by recurrent scandals and also by sweeping reforms and liberalisation.
47. The problems of securing the medical supply chains stem from
a combination of systemic factors in the health sector. They are
the result of malfunctions that can be observed throughout the chains,
ranging from the development of medical service to its provision,
and to a lack of transparency and accountability. They concern manufacturers,
distributors, wholesalers, pharmacies, hospitals, health professionals
and patients. The sector is particularly exposed to issues of governance
but also of corruption. Prevention efforts and the introduction of
warning systems and means of prosecuting transgressions should be
reinforced.
48. The right to protection of individual’s health is key to the
enjoyment of every other fundamental right. As counterfeiting medical
products is a transnational crime which does not recognise boundaries,
more States should sign and ratify the MEDICRIME Convention to strengthen
their power to combat this scourge. To mark the MEDICRIME Convention’s
10th anniversary, the Committee of Ministers
of the Council of Europe recently adopted a Declaration reaffirming
the key roles of the MEDICRIME Convention in which was underlined
its importance in guaranteeing and promoting the protection of public
health and of its Committee of the Parties as the sole and steering
committee to monitor the implementation of the convention. The Declaration
invited States to sign and ratify the convention, in line with the
suggestion made at the 131st Ministerial
Session.
Note
49. The strengthening of medical supply chains must be a public
health priority. If the fragilities of our supply chains are not
quickly addressed, we risk having future crises in which our global
supply chains are severely affected once again. The Covid-19 pandemic
had an unprecedented impact on the world, but it will not be the last
of its kind. The war of aggression inflicted by the Russian Federation
on Ukraine and the waves of sanctions decided are likely to have
adverse consequences in terms of medical supplies. In addition to
the provision of substances used by the pharmaceuticals industry,
the EMA notes that the continuation of clinical trials in the region
is already threatened for the foreseeable future.
Note Other threats to our global medical
supply chains include events such as climate change and natural
disasters, shifting global economic and geopolitical conditions,
or the threat of cyberattacks.
Note Medical supply chains must therefore
be carefully studied in order to better identify vulnerabilities
and focus on making them more robust, so as to minimise the risks
for future disruptions.
50. No single country is able to manage supply chain challenges
by itself. More than ever, international co-operation is needed
to secure safe medical supply chains. Member States must ensure
that the right to protection of health is always guaranteed, as
provided notably by Article 11 of the European Social Charter.
51. The French consumers association UFC concluded its 2020 survey
by demanding: an obligation for laboratories to stockpile sufficient
quantities of all medicines of major therapeutic value to cover
the needs of health system users; the strengthening, in law and
in practice, of sanctions for laboratories that are negligent in
their management of supplies for the French market; that if companies
use public funding to relocate, this should be permitted only for
operations concerning medicines of major therapeutic value and that
the longest established drugs recurrently in short supply should
be treated as a priority; and finally that public-sector pharmaceutical
production be developed to ensure manufacturing continuity for products
dropped by laboratories.
52. In efforts to ensure safe supply chains, the right to protection
of health as defined by WHO should be emphasised. This objective
is further refined by the Oviedo Convention, which establishes an
additional specific requirement of equitable access to healthcare
of an appropriate quality in Article 3. To achieve this goal, it
would be useful to be able to benefit from reinforced expertise
geared to that very definition of health. However, the Council of
Europe's European Health Committee and Health Division ceased to
exist in 2011, which is regrettable. That said, under the auspices
of the Committee of Ministers, the Steering Committee for Human
Rights in the fields of Biomedicine and Health (CDBIO) replaced
the Committee on Bioethics (DH-BIO) in January 2022, one of its
missions being to ensure that priorities in accessing scarce health
resources are set consistently and with respect for human dignity
and the protection of human rights. This is both a public health
requirement and an individual right. The approach of the Council
of Europe is through its human rights-focus to guarantee quality,
safety, and fairness. It must be capable of initiating a transparent
dialogue with the member States where the preservation of human
rights is concerned.
53. If confidence is to be restored, the right to protection of
health must be positioned as the sector's sole reason to exist.
The functioning of the supply chains is clearly problematic. We
must learn the necessary lessons, including from the succession
of scandals that have damaged the reputation of manufacturers as
well as from the shortages of useful and inexpensive drugs and from
the marketing of new products. Faced with these incidents, it is
necessary to optimise the functioning of the consultation and debate
bodies where the authorities can also exchange good practices and
take part in a constructive debate with all the players in the sector
and their representatives on all the health related topics. In addition
to the pragmatic management of the supply chain issues described
and in discussion by European regulatory bodies (EMA, OECD, EDQM), these
bodies could set themselves the overall aim, drawing on past proposals
from Jonathan Mann, former WHO administrator and a pioneer of the
fight against AIDS, of assisting the sector's players in the drawing
up of a code of ethics for public health and adoption of a classification
of violations of the right to health. This operation would comprise
three phases, reinforcing: public health ethics at the professional
level, applicable individually to practitioners; public health ethics
applied in specific cases where moral judgements are to be made,
particularly where arbitration is needed between the management
of society's assets and individual interests; and public health
ethics which must serve the interests of communities, especially
where the most vulnerable are concerned.
