Securing safe medical supply chains
- Author(s):
- Parliamentary Assembly
- Origin
- Text
adopted by the Standing Committee, acting on behalf of
the Assembly, on 25 November 2022 (see Doc. 15653, report of the Committee on Social Affairs, Health and
Sustainable Development, rapporteur: Ms Jennifer De Temmerman). See
also Recommendation 2243
(2022).
1. Medical supply
chains are one of the cornerstones of public health and contribute
to the implementation of the human right to protection of health.
Yet the adoption by public authorities and the pharmaceutical industry of
a largely financial approach, seeking to contain costs, increases
the risks of shortages. All our health systems suffer the consequences
of this, at the risk of jeopardising the quality of life, the health
and even the survival of people who rely on medical products. The
model which has led to the production of medicines being concentrated
in only a few countries has reached its limits. It has failed to
provide fair access to protection of health for all, and to medical
products across countries.
2. The Covid-19 pandemic has highlighted the need to address
the vulnerabilities of global medical supply chains, from the production
of medical products to their use by patients. During this crisis,
particularly in the early stages, 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.
3. The Parliamentary Assembly regrets that the relocation of
much of the pharmaceutical industry to India and China has not been
of benefit to everyone because technology transfers have been limited.
Production of new Covid-19 vaccines was concentrated in northern
countries, while vaccine coverage remained highly inadequate in
the south, and this made it impossible to remedy this situation
in our shared interest to contain the disease as quickly as possible.
The Assembly reiterates the conclusions it came to in its
Resolution 2424 (2022) “Beating Covid-19 with public health measures”.
4. The Council of Europe has a role to play in preventing and
combating this phenomenon, in collaboration with the World Health
Organization and the European Union. It reacted rapidly to the Covid-19
pandemic, providing its member States with tools and expertise to
ensure that the Organisation’s core values and principles at were
not undermined by the crisis. The Secretary General 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 Council of Europe Convention on the Counterfeiting
of Medical Products and Similar Crimes involving Threats to Public
Health (CETS No. 211, Medicrime Convention).
5. The Assembly welcomes the innovative step which the Medicrime
Convention represents. It is currently the only binding international
legal instrument in the criminal law field on the counterfeiting
of medical products and similar crimes involving threats to public
health. In view of the growing risk of counterfeiting stemming from shortages
of medicines and medical products, the Assembly regrets that the
convention has only been ratified by 13 member States and 6 non-member
States. It calls on States which have not yet done so to ratify
this convention.
6. The Assembly encourages parliaments to address the question
of the implementation of a human rights-based approach in the health
field, ensuring quality, safety and fairness in healthcare for all
as proposed by the Oviedo Convention. It deplores the shortages
of medical products which are at the origin of differences in treatment
and of discrimination. It calls on its member States to debate the
need to adopt co-ordinated approaches providing a flexible response
to unpredictable health crises, requiring unprecedented solutions such
as group purchasing of medicines or quick reactions to prevent bottlenecks
liable to disrupt the supply chains and have an impact on health.
Such responses help to make health systems more resilient.
7. In the context of the persistent shortages which affect individually
the most vulnerable people, especially women and people with long-term
and chronic illnesses, the Assembly deplores these discriminations
and calls on national authorities and all health stakeholders to
agree on a strategy to make medical supply chains safer in order
to guarantee equitable access and necessary prevention against supply
shortages. It encourages the authorities to establish firm legal
obligations if the risks are not alleviated by concerted action
in the near future. The goal of securing medical supplies deserves
our full attention until it is achieved. These measures could involve:
7.1 an obligation for laboratories
to stockpile sufficient quantities of all medicines of major therapeutic value
to cover the needs of health-system users;
7.2 strengthening, in law and in practice, sanctions for laboratories
that are negligent in their management of supplies for domestic
markets;
7.3 establishing that if companies use public funding to relocate
production sites to Europe, this should be permitted only for operations
concerning medicines of major therapeutic value, and particularly
concerning the longest established drugs with demonstrated efficacy
which are repeatedly in short supply;
7.4 expanding public-sector pharmaceutical production to ensure
manufacturing continuity for products that are discontinued by laboratories.
8. In anticipation of future pandemics, the Assembly calls on
member States to set up comprehensive strategies to secure medical
supply chains, guaranteeing quality, safety and fairness between
countries. It also proposes putting in place prevention, contingency
and mitigation strategies regarding shortages of medical products.
9. To cater for the adjustments needed in response to the climate
crisis, the Assembly calls for the development of an environment-friendly,
efficient and resilient health system based on human rights, and
with a high level of integrity. It also recommends:
9.1 cutting emissions of polluting
gases linked to purchases of medicines and medical devices;
9.2 cutting emissions of polluting gases linked to all the
stages in the energy consumption chain;
9.3 taking action on waste;
9.4 using digital technology to support decarbonisation.
10. Lastly, referring to
Resolution
2071 (2015) “Public health and the interests of the pharmaceutical industry:
how to guarantee the primacy of public health interests?”, the Assembly
calls on the pharmaceutical industry, companies and associations,
as well as on wholesalers, to step up their efforts to increase transparency
and co-operate more closely with the public authorities and to take
into account the individual right to protection of health, as well
as fairness between countries. Finally, it calls for professional
ethical standards to be enhanced so as to restore patient trust.
