Council of Europe Convention on the Counterfeiting of Medical Products: Difference between revisions

MEDICRIME Convention
Council of Europe Convention on the Counterfeiting of Medical Products and Similar Crimes involving Threats to Public Health
Signed	28 October 2011
Standort	Moscow, Russia
Effective	1 January 2016
Condition	5 ratifications, including at least 3 Council of Europe member states
Signatories	16 signatures and 16 ratifications
Parties	16 (as of October 2019)
Depositary	Secretary General of the Council of Europe
Languages	French and English

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The Council of Europe Convention on the Counterfeiting of Medical Products and Similar Crimes involving Threats to Public Health, also known as the MEDICRIME Convention,^[1] is an international criminal law convention, established by the Council of Europe. It focuses on combating the falsification of medicines and medical devices.

History

The convention was approved by the Committee of Ministers of the Council of Europe in 2010 and made available for signing at a prominent conference held in Moscow on October 28, 2011.^[2] The official versions of the convention are in English and French, both of which have equal authenticity.^[3] Non-official translations in other languages are also accessible,^[4] but should be considered for informational purposes only.

Currently, the MEDICRIME Convention stands as the sole international legal instrument that enables the criminalization of counterfeit medical products.

Despite being developed by a European institution, this convention is open for signing and ratification^[5] by countries outside of Europe as well.

Products covered by the convention

The scope of the MEDICRIME Convention encompasses various categories, such as medicines intended for human and veterinary use, as well as the ingredients, components, and materials utilized in the manufacturing of medicines. Additionally, it includes medical devices, accessories, and medicines employed in clinical trials.

Key provisions

The treaty comprises 33 articles that are structured around three main pillars:

Criminalizing the falsification of medicines and medical devices.
Safeguarding the rights of victims.
Promoting cooperation at national and international levels.

It is important to note that the convention focuses on criminal law aspects and does not address unintentional quality defects^[6] or violations of intellectual property rights. While the term "counterfeit" may be used to refer to a false representation regarding identity and/or source, the preferred term within the medical context is "falsification," as the primary aim is to protect public health.

Criminalizing the falsification of medicines and medical devices

The convention addresses certain acts that are deemed dangerous to public health and criminalizes them. It is important to note that only intentional acts are considered punishable offenses.

According to Article 5 of the convention, the intentional manufacturing of falsified medical products, active substances, excipients, parts, materials, and accessories is classified as a criminal offense.

Article 6 states that the intentional supply (including brokering, procuring, selling, donating, offering for free, and promoting), possession for the purpose of supply, import, and export of falsified medical products, active substances, excipients, parts, materials, and accessories are criminal offenses.

Article 7 specifies that intentionally producing false documents and tampering with existing ones are criminal offenses.

Article 8 identifies offenses that are considered similar to falsification due to their significant threat to public health. This includes the intentional manufacturing or placing on the market of medicinal products without authorization^[7]^[8] as well as the inclusion of medical devices that do not comply with conformity requirements.^[9]^[10]

Protecting victims’ rights

The convention strengthens the rights of victims by guaranteeing their access to pertinent information, supporting their recovery, and facilitating their compensation, among other provisions. It is important to note that victims are not obligated to press charges or provide evidence of harm in order for an investigation to be initiated; the potential risk to public health is considered sufficient.

Encouraging national and international co-operation

Promoting and facilitating cooperation at both national and international levels is a significant aspect of the convention. Given the diverse range of stakeholders involved in addressing the growing occurrence of such crimes, including health authorities, law enforcement agencies, customs services, and the judiciary, it is important to encourage and facilitate synergies and collaboration among them. States that are parties to the convention are urged to establish a mechanism that enables seamless information exchange and cooperation within and across borders.

Parties

As of February 2021, the Convention on the Falsification of Medical Products and Similar Crimes involving Threats to Public Health has been ratified by 18 state parties. These include Albania, Armenia, Belgium, Belarus, Benin, Bosnia and Herzegovina, Burkina Faso, Croatia, France, Guinea, Hungary, Portugal, the Republic of Moldova, the Russian Federation, Spain, Switzerland, Turkey, and Ukraine. Additionally, 15 countries have signed the convention but have not yet ratified it. The Committee of Ministers of the Council of Europe has extended invitations to Congo, Ecuador, and Tunisia to join the MEDICRIME convention.^[5]^[11]

In July 2017, Burkina Faso became the 10th country to ratify the convention, triggering the establishment of the Committee of the Parties. This committee, named the MEDICRIME Committee, is the convention’s monitoring body and is tasked with facilitating the implementation and follow-up of the convention in the state parties as well as the collection, analysis, and exchange of information, experience, and good practice between states to improve their capacity to prevent and combat the counterfeiting of medical products and similar crimes involving threats to public health. Its first meeting took place in December 2018, and it adopted its rules or procedure in its second meeting on December 12–13, 2020.^[12]

References

^ Mogaka, Gilbas (28 November 2023). "MEDICRIME Convention". Council of Europe Treaty Office. Archived from the original on 2018-08-24. Retrieved 2019-09-30.
^ "Remarks by Russian Foreign Minister Sergey Lavrov at the Opening for Signature Ceremony of the Council of Europe Convention on Falsification of Medical Products and Similar Crimes involving Threats to Public Health (Medicrime Convention), Moscow, October 28, 2011". www.mid.ru. Retrieved 2019-09-30.
^ "Translations". Council of Europe Treaty Office. Retrieved 2019-09-30.
^ "Official and non-official languages". Council of Europe Treaty Office. Retrieved 2019-09-30.
^ ^a ^b "Chart of signatures and ratifications of Treaty 211". Council of Europe Treaty Office. Retrieved 2019-09-30.
^ "Quality defects and recalls". European Medicines Agency. 17 September 2018. Retrieved 2019-09-30.
^ "The European regulatory system for medicines", European Medecines Agency. Retrieved 2019-09-30.
^ "The Drug Development Process". U.S. Food and Drug Administration. Retrieved 2019-09-30.
^ "Conformity assessment". European Commission – Internal Market, Industry, Entrepreneurship and SMEs. Retrieved 2019-09-30.
^ "CE marking". European Union – Your Europe. Retrieved 2019-09-30.
^ "Treaty Office Glossary". Council of Europe Treaty Office. Retrieved 2019-09-30.
^ "Committee of Parties".

External links

[1] Mogaka, Gilbas (28 November 2023). "MEDICRIME Convention". Council of Europe Treaty Office. Archived from the original on 2018-08-24. Retrieved 2019-09-30.

[2] "Remarks by Russian Foreign Minister Sergey Lavrov at the Opening for Signature Ceremony of the Council of Europe Convention on Falsification of Medical Products and Similar Crimes involving Threats to Public Health (Medicrime Convention), Moscow, October 28, 2011". www.mid.ru. Retrieved 2019-09-30.

[3] "Translations". Council of Europe Treaty Office. Retrieved 2019-09-30.

[4] "Official and non-official languages". Council of Europe Treaty Office. Retrieved 2019-09-30.

[:0-5] "Chart of signatures and ratifications of Treaty 211". Council of Europe Treaty Office. Retrieved 2019-09-30.

[6] "Quality defects and recalls". European Medicines Agency. 17 September 2018. Retrieved 2019-09-30.

[7] "The European regulatory system for medicines", European Medecines Agency. Retrieved 2019-09-30.

[8] "The Drug Development Process". U.S. Food and Drug Administration. Retrieved 2019-09-30.

[9] "Conformity assessment". European Commission – Internal Market, Industry, Entrepreneurship and SMEs. Retrieved 2019-09-30.

[10] "CE marking". European Union – Your Europe. Retrieved 2019-09-30.

[11] "Treaty Office Glossary". Council of Europe Treaty Office. Retrieved 2019-09-30.

[12] "Committee of Parties".

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@@ Line 1: / Line 1: @@
+{{Short description|International criminal law treaty}}
-{{Infobox treaty
+{{Tone|date=January 2023}}{{Infobox treaty
 | name                =MEDICRIME Convention
-| long_name           = Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health
+| long_name           = Council of Europe Convention on the Counterfeiting of Medical Products and Similar Crimes involving Threats to Public Health
 | image               =
 | image_width         =
 | caption             =
-| type                =
-| date_drafted        =9 December 2010
 | date_signed         = 28 October 2011
 | location_signed     =[[Moscow]], Russia
+| condition_effective =5 ratifications, including at least 3 Council of Europe member states
-| date_sealed         =
+| signatories         =16 signatures and 16 ratifications
-| date_effective      = ''1 January 2016''
+| parties             =16 (as of October 2019)
-| condition_effective = 5 ratifications, including 3 Council of Europe members
+| depositor           =Secretary General of the Council of Europe
-| date_expiration     =
-| signatories         =24
+| languages           =French and English
+| wikisource          =
-| parties             =open for signature by the member States and observers of the Council of Europe, the European Union, Israel and Japan; as well as other invited states
+|date_effective =1 January 2016}}The '''Council of Europe Convention on the Counterfeiting of Medical Products and Similar Crimes involving Threats to Public Health''', also known as the '''MEDICRIME Convention''',<ref>{{Cite web |last=Mogaka |first=Gilbas |date=28 November 2023 |title=MEDICRIME Convention |url=https://www.coe.int/en/web/conventions/full-list |url-status=dead |archive-url=https://web.archive.org/web/20180824084230/https://www.coe.int/en/web/conventions/full-list |archive-date=2018-08-24 |access-date=2019-09-30 |website=Council of Europe Treaty Office |language=en-GB }}</ref> is an international criminal law [[Treaty|convention]], established by the [[Council of Europe]]. It focuses on combating the falsification of medicines and medical devices.
-| ratifiers           = 5 (Guinea, Hungary, Moldova, Spain, and Ukraine)
-| depositor           = Secretary General of the Council of Europe
-| language            =
-| languages           = French and English
-| wikisource          =Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health
-}}
-The '''Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health''' (or '''MEDICRIME convention''')<ref>{{cite web|url=http://www.coe.int/t/DGHL/StandardSetting/MediCrime/Default_en.asp|title=Medicrime|accessdate=23 February 2011|work=[[Council of Europe]]}}</ref> is a multilateral [[Treaty|convention]] of the [[Council of Europe]] aiming at prevention of counterfeiting medical products. Its purpose is threefold (article 1):
-::a) providing for the criminalisation of certain acts;
-::b) protecting the rights of victims of the offences established under this Convention;
-::c) promoting national and international co-operation.
+== History ==
-As of late-September 2015, the treaty has been ratified by [[Guinea]], [[Hungary]], [[Moldova]], [[Spain]], and [[Ukraine]]. Having been ratified by the requisite five states (at least three of which had to be Council of Europe states), the convention is scheduled to enter into force for the ratifying parties on 1 January 2016.<ref>{{cite web|url=http://www.coe.int/en/web/portal/full-news/-/asset_publisher/rfs6RdVHzAWb/content/counterfeiting-of-medical-products-entry-into-force-of-the-medicrime-convention?_101_INSTANCE_rfs6RdVHzAWb_viewMode=view|title=Counterfeiting of medical products. Entry into force of the Medicrime Convention|date=24 September 2015|publisher=COUNCIL OF EUROPE|accessdate=25 October 2015}}</ref>
+The convention was approved by the [[Committee of Ministers of the Council of Europe]] in 2010 and made available for signing at a prominent conference held in Moscow on October 28, 2011.<ref>{{Cite web|url=http://www.mid.ru/posledniye_dobavlnenniye/-/asset_publisher/MCZ7HQuMdqBY/content/id/187690|title=Remarks by Russian Foreign Minister Sergey Lavrov at the Opening for Signature Ceremony of the Council of Europe Convention on Falsification of Medical Products and Similar Crimes involving Threats to Public Health (Medicrime Convention), Moscow, October 28, 2011|website=www.mid.ru|language=en-GB|access-date=2019-09-30}}</ref> The official versions of the convention are in English and French, both of which have [[Equal authenticity rule|equal authenticity]].<ref>{{Cite web|url=https://www.coe.int/en/web/conventions/translations|title=Translations|last=|first=|date=|website=Council of Europe Treaty Office|language=en-GB|archive-url=|archive-date=|access-date=2019-09-30}}</ref> Non-official translations in other languages are also accessible,<ref>{{Cite web|url=https://www.coe.int/en/web/conventions/full-list|title=Official and non-official languages|last=|first=|date=|website=Council of Europe Treaty Office|language=en-GB|archive-url=|archive-date=|access-date=2019-09-30}}</ref> but should be considered for informational purposes only.
+Currently, the MEDICRIME Convention stands as the sole international legal instrument that enables the criminalization of counterfeit medical products.
+Despite being developed by a European institution, this convention is open for signing and [[ratification]]<ref name=":0">{{Cite web |last= |first= |date= |title=Chart of signatures and ratifications of Treaty 211 |url=https://www.coe.int/en/web/conventions/full-list |archive-url= |archive-date= |access-date=2019-09-30 |website=Council of Europe Treaty Office |language=en-GB}}</ref> by countries outside of Europe as well.
+== Products covered by the convention ==
+The scope of the MEDICRIME Convention encompasses various categories, such as medicines intended for human and veterinary use, as well as the ingredients, components, and materials utilized in the manufacturing of medicines. Additionally, it includes [[medical device]]s, accessories, and medicines employed in [[clinical trial]]s.
+== Key provisions ==
+The treaty comprises 33 articles that are structured around three main pillars:
+# [[Criminalization|Criminalizing]] the falsification of medicines and medical devices.
+# Safeguarding the rights of victims.
+# Promoting cooperation at national and international levels.
+It is important to note that the convention focuses on criminal law aspects and does not address unintentional quality defects<ref>{{Cite web|url=https://www.ema.europa.eu/en/human-regulatory/post-authorisation/compliance/quality-defects-recalls|title=Quality defects and recalls|last=|first=|date=17 September 2018|website=European Medicines Agency|language=en|archive-url=|archive-date=|access-date=2019-09-30}}</ref> or violations of [[Intellectual property|intellectual property rights]]. While the term "[[counterfeit]]" may be used to refer to a false representation regarding identity and/or source, the preferred term within the medical context is "falsification," as the primary aim is to protect public health.
+=== Criminalizing the falsification of medicines and medical devices ===
+The convention addresses certain acts that are deemed dangerous to public health and criminalizes them. It is important to note that only intentional acts are considered punishable offenses.
+According to Article 5 of the convention, the intentional manufacturing of falsified medical products, [[Active ingredient|active substances]], [[excipient]]s, parts, materials, and accessories is classified as a criminal offense.
+Article 6 states that the intentional supply (including brokering, procuring, selling, donating, offering for free, and promoting), possession for the purpose of supply, import, and export of falsified medical products, active substances, excipients, parts, materials, and accessories are criminal offenses.
+Article 7 specifies that intentionally producing false documents and tampering with existing ones are criminal offenses.
+Article 8 identifies offenses that are considered similar to falsification due to their significant threat to public health. This includes the intentional manufacturing or placing on the market of medicinal products without authorization<ref>"[https://www.ema.europa.eu/en/documents/leaflet/european-regulatory-system-medicines-european-medicines-agency-consistent-approach-medicines_en.pdf The European regulatory system for medicines"], ''European Medecines Agency''. Retrieved 2019-09-30.</ref><ref>{{Cite web|url=https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process|title=The Drug Development Process|last=|first=|date=|website=U.S. Food and Drug Administration|language=en|archive-url=|archive-date=|access-date=2019-09-30}}</ref> as well as the inclusion of medical devices that do not comply with [[conformity]] requirements.<ref>{{Cite web|url=https://ec.europa.eu/growth/single-market/goods/building-blocks/conformity-assessment_en|title=Conformity assessment|last=|first=|date=|website=European Commission – Internal Market, Industry, Entrepreneurship and SMEs|language=en|archive-url=|archive-date=|access-date=2019-09-30}}</ref><ref>{{Cite web|url=https://europa.eu/youreurope/business/product-requirements/labels-markings/ce-marking/index_en.htm|title=CE marking|last=|first=|date=|website=European Union – Your Europe|language=en|archive-url=|archive-date=|access-date=2019-09-30}}</ref>
+=== Protecting victims’ rights ===
+The convention strengthens the rights of victims by guaranteeing their access to pertinent information, supporting their recovery, and facilitating their compensation, among other provisions. It is important to note that victims are not obligated to press charges or provide evidence of harm in order for an investigation to be initiated; the potential risk to public health is considered sufficient.
+=== Encouraging national and international co-operation ===
+Promoting and facilitating cooperation at both national and international levels is a significant aspect of the convention. Given the diverse range of stakeholders involved in addressing the growing occurrence of such crimes, including health authorities, law enforcement agencies, customs services, and the judiciary, it is important to encourage and facilitate synergies and collaboration among them. States that are parties to the convention are urged to establish a mechanism that enables seamless information exchange and cooperation within and across borders.
+== Parties==
+[[File:States Parties Medicrime Convention map EN.png|alt=Signatures and ratifications of the Council of Europe MEDICRIME Convention (CETS No. 211)|thumb|Signatures and ratifications of the Council of Europe MEDICRIME Convention (CETS No. 211)]]
+As of February 2021, the Convention on the Falsification of Medical Products and Similar Crimes involving Threats to Public Health has been ratified by 18 state parties. These include [[Albania]], [[Armenia]], [[Belgium]], [[Belarus]], [[Benin]], [[Bosnia and Herzegovina]], [[Burkina Faso]], Croatia, [[France]], [[Guinea]], [[Hungary]], [[Portugal]], [[Moldova|the Republic of Moldova]], [[Russia|the Russian Federation]], [[Spain]], [[Switzerland]], [[Turkey]], and [[Ukraine]]. Additionally, 15 countries have signed the convention but have not yet ratified it. The Committee of Ministers of the Council of Europe has extended invitations to [[Democratic Republic of the Congo|Congo]], [[Ecuador]], and [[Tunisia]] to join the MEDICRIME convention.<ref name=":0" /><ref>{{Cite web|url=https://www.coe.int/en/web/conventions/glossary|title=Treaty Office Glossary|last=|first=|date=|website=Council of Europe Treaty Office|language=en-GB|archive-url=|archive-date=|access-date=2019-09-30}}</ref>
+In July 2017, Burkina Faso became the 10th country to ratify the convention, triggering the establishment of the Committee of the Parties. This committee, named the MEDICRIME Committee, is the convention’s monitoring body and is tasked with facilitating the implementation and follow-up of the convention in the state parties as well as the collection, analysis, and exchange of information, experience, and good practice between states to improve their capacity to prevent and combat the counterfeiting of medical products and similar crimes involving threats to public health. Its first meeting took place in December 2018, and it adopted its rules or procedure in its second meeting on December 12–13, 2020.<ref>{{Cite web|url=https://www.coe.int/en/web/medicrime/committee-of-parties|title=Committee of Parties}}</ref>
 ==See also==
 *[[Anti-Counterfeiting Trade Agreement]]
+*[[List of Council of Europe treaties]]
 ==References==
@@ Line 35: / Line 67: @@
 ==External links==
+{{Commons category|Council of Europe Convention on the Counterfeiting of Medical Products}}
-*[http://conventions.coe.int/Treaty/EN/Treaties/Html/211.htm Treaty text]
+*[https://www.coe.int/en/web/conventions/full-list/-/conventions/rms/090000168008482f Council of Europe Convention on the Counterfeiting of Medical Products and Similar Crimes involving Threats to Public Health (CETS No. 211), the MEDICRIME Convention]
-*[http://www.conventions.coe.int/Treaty/Commun/ChercheSig.asp?NT=211&CM=8&DF=23/02/2012&CL=ENG signatures and ratifications]
+*[https://www.coe.int/en/web/medicrime/home The MEDICRIME Convention – Latest news]
+*[https://www.fondationchirac.eu/2016/01/la-convention-medicrime-entre-en-vigueur/ Fondation Chirac: "La Convention MÉDICRIME entre en vigueur !"]
+*[http://gabi-journal.net/the-medicrime-convention-criminalising-the-falsification-of-medicines-and-similar-crimes.html GaBi Journal: "The MEDICRIME Convention: criminalising the falsification of medicines and similar crimes"]
+*[http://fightthefakes.org/resources/the-medicrime-convention-2/ Fight the Fakes: The MEDICRIME Convention]
 [[Category:Anti-counterfeiting treaties]]
@@ Line 43: / Line 79: @@
 [[Category:Medical crime]]
 [[Category:Council of Europe treaties]]
-[[Category:Treaties not entered into force]]
 [[Category:Treaties concluded in 2011]]
+[[Category:Treaties of Albania]]
+[[Category:Treaties of Armenia]]
+[[Category:Treaties of Belgium]]
+[[Category:Treaties of Benin]]
+[[Category:Treaties of Burkina Faso]]
+[[Category:Treaties of Croatia]]
+[[Category:Treaties of France]]
 [[Category:Treaties of Guinea]]
 [[Category:Treaties of Hungary]]
 [[Category:Treaties of Moldova]]
+[[Category:Treaties of Portugal]]
+[[Category:Treaties of Russia]]
 [[Category:Treaties of Spain]]
+[[Category:Treaties of Switzerland]]
+[[Category:Treaties of Turkey]]
 [[Category:Treaties of Ukraine]]
 [[Category:2011 in Russia]]
-[[Category:Treaties entered into force in 2016]]<!-- should not be created until 1/1/2016 -->
+[[Category:Treaties entered into force in 2016]]