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{{Short description|International criminal law treaty}}{{Tone|date=January 2023}}{{Infobox treaty
{{Short description|International criminal law treaty}}
{{Tone|date=January 2023}}{{Infobox treaty
| name =MEDICRIME Convention
| 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
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| languages =French and English
| languages =French and English
| wikisource =
| wikisource =
|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.
|date_effective =1 January 2016}}
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=https://www.coe.int/en/web/conventions/full-list|title=MEDICRIME Convention|last=|first=|date=|website=Council of Europe Treaty Office|language=en-GB|url-status=live|archive-url=|archive-date=|access-date=2019-09-30}}</ref> is an international criminal law [[Treaty|convention]] of the [[Council of Europe]] addressing the falsification of medicines and medical devices.

== Background ==
The falsification of medicines and medical devices is an extremely profitable, low-risk form of crime, even in comparison with drug trafficking. These crimes endanger people’s health and lives, and thus may even violate the right to life enshrined in the [[European Convention on Human Rights]]. They also undermine public trust in health-care systems and health surveillance authorities.


== History ==
== History ==
The convention was adopted by the [[Committee of Ministers of the Council of Europe]] in 2010, and opened for signature at a high-level conference organised in Moscow on 28 October 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> Its official texts are in English and French, which are [[Equal authenticity rule|equally authentic]].<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|url-status=live|archive-url=|archive-date=|access-date=2019-09-30}}</ref> Other translations in non-official languages are also available,<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|url-status=live|archive-url=|archive-date=|access-date=2019-09-30}}</ref> but they are for information purposes only.
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.


To date, the MEDICRIME Convention is the only international legal instrument providing the means to criminalise the falsification of medical products.
Currently, the MEDICRIME Convention stands as the sole international legal instrument that enables the criminalization of counterfeit medical products.


Although drafted by a European institution, this convention is also open for signature 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 |url-status=live |archive-url= |archive-date= |access-date=2019-09-30 |website=Council of Europe Treaty Office |language=en-GB}}</ref> by non-European countries.
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 ==
== Products covered by the convention ==
Medicines for human and veterinary use, ingredients, parts and materials used in the production of medicines, [[Medical device|medical devices]], accessories and [[Clinical trial|clinical trial medicines]].
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 ==
== Key provisions ==
The treaty contains 33 articles, organised in three fundamental pillars:
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.
# [[Criminalization|criminalising]] the falsification of medicines and medical devices;
# protecting victims’ rights;
# encouraging national and international co-operation.


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.
As a criminal law instrument, the convention does not deal with 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|url-status=live|archive-url=|archive-date=|access-date=2019-09-30}}</ref> nor with the violation of [[Intellectual property|intellectual property rights]]. It may use the term “counterfeit” meaning a “false representation as regards identity and/or source", but “falsification” is preferred as Medicrime is solely about protecting public health.


Article 7 specifies that intentionally producing false documents and tampering with existing ones are criminal offenses.
=== Criminalising the falsification of medicines and medical devices ===
The convention criminalises certain acts because dangerous to public health. Only intentional acts are punishable offences.


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>
* Article 5 stipulates that the intentional manufacturing of falsified medical products, [[Active ingredient|active substances]], [[Excipient|excipients]], parts, materials and accessories is a criminal offence.
* Article 6 provides that the intentional supplying (brokering, procuring, selling, donating or offering for free and promoting), keeping in stock, importing and exporting of falsified medical products, active substances, excipients, parts, materials and accessories are criminal offences.
* Article 7 specifies that intentionally producing false documents and tampering with existing ones are criminal offences.
* Article 8 establishes offences that are considered similar to falsification because they pose a serious threat to public health, such as intentionally manufacturing or placing medicinal products on the market without authorisation,<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|url-status=live|archive-url=|archive-date=|access-date=2019-09-30}}</ref> including medical devices that fail to 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|url-status=live|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|url-status=live|archive-url=|archive-date=|access-date=2019-09-30}}</ref>


=== Protecting victims’ rights ===
=== Protecting victims’ rights ===
The convention reinforces victims' rights by ensuring that they have access to all information relevant to their case, assisting them in their recovery and providing for their compensation, among others. Victims are not required to file charges or prove any harm suffered for an investigation to be opened – the risk of a threat to health is sufficient.
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 ===
=== Encouraging national and international co-operation ===
Co-operation at national and international level is an important aspect of the convention. Given the wide range of stakeholders confronted with the increasing prevalence of such crimes, from health authorities and law-enforcement agencies to customs services and the judiciary, synergies and co-operation among them should be promoted and facilitated. States parties to the convention are encouraged to set up a mechanism enabling the smooth exchange of information and co-operation within and across borders.
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==
== 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)]]
[[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, there are 18 State Parties to the Convention on the Falsification of Medical Products and Similar Crimes involving Threats to Public Health: [[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]]. Another 15 countries have signed but not ratified it. The Committee of Ministers of the Council of Europe invited [[Democratic Republic of the Congo|Congo]], [[Ecuador]] and [[Tunisia]] to accede to 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|url-status=live|archive-url=|archive-date=|access-date=2019-09-30}}</ref>
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 to facilitate 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 12-13 December 2020.<ref>{{Cite web|url=https://www.coe.int/en/web/medicrime/committee-of-parties|title=Committee of Parties}}</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==
==See also==
Line 67: Line 67:


==External links==
==External links==
{{Commonscat|Council of Europe Convention on the Counterfeiting of Medical Products}}
{{Commons category|Council of Europe Convention on the Counterfeiting of Medical Products}}
*[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]
*[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]
*[https://www.coe.int/en/web/medicrime/home The MEDICRIME Convention – Latest news]
*[https://www.coe.int/en/web/medicrime/home The MEDICRIME Convention – Latest news]

Latest revision as of 17:00, 29 April 2024

MEDICRIME Convention
Council of Europe Convention on the Counterfeiting of Medical Products and Similar Crimes involving Threats to Public Health
Signed28 October 2011
StandortMoscow, Russia
Effective1 January 2016
Condition5 ratifications, including at least 3 Council of Europe member states
Signatories16 signatures and 16 ratifications
Parties16 (as of October 2019)
DepositarySecretary General of the Council of Europe
LanguagesFrench and English

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

[edit]

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

[edit]

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

[edit]

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

  1. Criminalizing the falsification of medicines and medical devices.
  2. Safeguarding the rights of victims.
  3. 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

[edit]

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

[edit]

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

[edit]

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

[edit]
Signatures and ratifications of the Council of Europe MEDICRIME Convention (CETS No. 211)
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, 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]

See also

[edit]

References

[edit]
  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.
  5. ^ a b "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".
[edit]