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User:BD2412/Vaccine law resources/International and comparative

< User:BD2412 | Vaccine law resources

Silas P. Trumbo, Cara B. Janusz, Barbara Jauregui, Mike McQuestion, Gabriela Felix, Cuauhtémoc Ruiz-Matus, Jon K. Andrus, and Ciro De Quadros, Vaccination legislation in Latin America and the Caribbean, Journal of Public Health Policy, Vol. 34, p. 82–99 (February 14, 2013), https://www.ncbi.nlm.nih.gov/pubmed/23407412 / https://link.springer.com/article/10.1057%2Fjphp.2012.66

Olivier Ethgen, Murielle Cornier, Emilie Chriv and Florence Baron-Papillon, The cost of vaccination throughout life: A western European overview, Human Vaccines & Immunotherapeutics, Volume 12, 2016, Issue 8, Pages 2029-2037, https://doi.org/10.1080/21645515.2016.1154649, https://www.tandfonline.com/doi/full/10.1080/21645515.2016.1154649, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4994732/

UN

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European Community

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TITLE I: DEFINITIONS

Article 1

4. Immunological medicinal product:

Any medicinal product consisting of vaccines, toxins, serums or allergen products:

(a) vaccines, toxins and serums shall cover in particular:

(i) agents used to produce active immunity, such as cholera vaccine, BCG, polio vaccines, smallpox vaccine;

(ii) agents used to diagnose the state of immunity, including in particular tuberculin and tuberculin PPD, toxins for the Schick and Dick Tests, brucellin;

(iii) agents used to produce passive immunity, such as diphtheria antitoxin, anti-smallpox globulin, antilymphocytic globulin;

Article 114

1. Where it considers it necessary in the interests of public health, a Member State may require the holder of an authorization for marketing:

— live vaccines,

— immunological medicinal products used in the primary immunization of infants or of other groups at risk,

— immunological medicinal products used in public health immunization programmes,

— new immunological medicinal products or immunological medicinal products manufactured using new or altered kinds of technology or new for a particular manufacturer, during a transitional period normally specified in the marketing authorization,

to submit samples from each batch of the bulk and/or the medicinal product for examination

3.2.1.2. Manufacturing process of the active substance(s)

...

c) For biological medicinal products, the following additional requirements shall apply.

Whenever possible, vaccine production shall be based on a seed lot system and on established cell banks. For bacterial and viral vaccines, the characteristics of the infectious agent shall be demonstrated on the seed. In addition, for live vaccines, the stability of the attenuation characteristics shall be demonstrated on the seed; if this proof is not sufficient, the attenuation characteristics shall also be demonstrated at the production stage.

1.2. Vaccines For vaccines for human use and by derogation from the provisions of Module 3 on ‘Active substance(s)’, the following requirements when based on the use of a Vaccine Antigen Master File system shall apply. The marketing authorisation application dossier of a vaccine other than human influenza vaccine, shall be required to include a Vaccine Antigen Master File for every vaccine antigen that is an active substance of this vaccine.

Specific countries

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Australia

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Mandates
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  • Emily Cossgrove, Holly Gretton and Darcy Harwood, Mandate to vaccinate: can employers make employees roll up their sleeves for the COVID-19 vaccine?,
    • Employer can direct employees to get vaccinated "so long as the direction is lawful and reasonable".
    • Ms Nicole Maree Arnold v Good­start Ear­ly Learn­ing Lim­it­ed T/A Good­start Ear­ly Learn­ing [2020] FWC 6083: "‘equally arguable’ that a policy issued by the child-care business requiring mandatory immunisation was lawful and reasonable in the context of its operations which principally involved the care of children".
    • Glover v Ozcare [2021] FWC 231 - case in progress in progress.
  • No jab, no job? legal risks for employers requiring covid-19 vaccination
    • "Work Health and Safety Act 2011 (Cth) (WHS Act), and equivalent state health and safety legislation (in Victoria, the Occupational Health and Safety Act 2004), broadly require employers to ensure, so far as is reasonably practicable, the health and safety of their workers and other persons while in the workplace".
    • Arnold v Goodstart Early Learning Limited T/A Goodstart Early Learning [2020] FWC 6093, childcare centre mandated flu vaccine for all workers, except those with a valid medical exemption. An employee refused and was terminated. Found to be reasonable given work with small children.
  • Glover v Ozcare [2021] FWC 231. Employer put employee on indefinite unpaid leave after flu vaccine refused due to previous anaphylaxis reaction. Employer argues that employee's position of administering care to vulnerable patients requires vaccination anyway, Case is pending.
  • Caitlin Walsh, Meena Iskandar, Natasha Sim, Morgan Smithe & Ellena Kouris, No jab, no job? Not at this stage for COVID-19 vaccinations (02 Mar 2021)
    • Employer can only require employee vaccination if "lawful and reasonable"
    • Safe Work Australia says "most employers" can get by with other safety measures
    • Fair Work Ombudsman guidelines say "the coronavirus pandemic, on its own, does not automatically make it reasonable for an employer to direct their employees to be vaccinated against coronavirus"
    • Can't discriminate against those with medical grounds for nonvaccination
    • Arnold v Goodstart Early Learning Limited t/as Goodstart Early Learning [2020] FWC 6083; claim against influenza vaccine mandate dismissed as untimely
Appointment of Enduring Guardian; depends on whether you have an Advanced Care Directive
  • Heather Richardson, Natalie Lasek, Jessica Seferis, How should employers manage the COVID-19 vaccination rollout (AU, April 12, 2021)
    • Fair Work Act 2009 (Cth) (Fair Work Act); reasonableness of mandate depends on industry/conditions
    • Office of the Australian Information Commissioner (OAIC) has released guidelines on COVID-19 vaccination privacy obligations
      • Employee must consent to info collection; info should only be collected as necessary for business functionsm, and should be the minimum needed; info must be kept secure
Adverse events
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IP
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  • Nicole Murdoch, Australia Can Over Ride European Hijack Of Covid Vaccine (18 March 2021)
    • EU reportedly seeks to strip AstraZenica IP rights in order to keep COVID-19 vaccine doses in Europe (rather than being shipped to Australia); piece proposes that Crown use exception in the Patents Act could be used by AU to similarly strip AU patent rights, so AU can manufacture its own doses of the vaccine.

Austria

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Brazil

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Canada

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  • Tatha Swann, Levitt Sheikh Chaudhri Swann, Persistent COVID-19 vaccine refusal potential firing offence, say employment lawyers (February 5, 2021)
    • "An employer’s duty under Ontario’s Occupational Health and Safety Act to take all reasonable precautions to protect the health and safety of workers provides a sound starting point for requiring workers to be vaccinated."
    • Up to employers unless there is a medical or human rights (i.e. religious) issue.
    • Occupational Health and Safety Act and the Reopening Ontario Act.
    • Likely not a breach of privacy to request documentation of diagnosis.
  • Ian Wilson, Jenifer C. Gentle, Alberta creates COVID-19 vaccine paid leave (April 22, 2021) - Alberta Government amended Employment Standards Code to require all employees (F/T, P/T, any length of employment) up to three hours of paid leave to get COVID-19 vaccine. Saskatchewan did so previously. British Columbia is working on it.

China

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2022
  • Beijing Rolls Out China’s First Ever Covid Vaccine Mandate, Bloomberg News (July 6, 2022): "The city will require live performances, entertainment venues such as movie theaters, museums and gyms, as well as training and tutoring locations, to restrict entry to people who are vaccinated".
  • Shuai Zhang, Beijing imposes, then backs off COVID vaccine mandate amid fresh outbreaks, CBS News (July 7, 2022): "Beijing authorities issued a requirement for all residents entering large public places, including museums, theaters, and gyms, to show proof of vaccination, according to an official with the Municipal Health Commission. Senior citizens were also told they must show proof of vaccination to enter community facilities". However, two days later, "a local health authority said people could still enter public venues as long as they could show a negative COVID-19 test result from within 72 hours, and their body temperatures were normal".

Colombia

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France

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Germany

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A form of emergency use of an investigational vaccine was employed in Germany in 2009, when a laboratory worker sustained a needlestick while handling Ebola virus. An investigational vaccine developed in Canada and based on vesicular stomatitis virus expressing an Ebola virus envelope glycoprotein was administered to the worker, who did not develop symptoms of disease (Enserink 2009).

  • Robert Grohmann, COVID-19: STATE INTERVENTION IN TIMES OF VACCINE SHORTAGES (March 2, 2021)
    • German Infection Protection Act (Infektionsschutzgesetz – "GIPA") amended early in pandemic to allow faster action, allowing "measures to ensure the supply of medicinal products, including vaccines"
    • Discusses requirements to take extraordinary measures, patent, liability for vaccine injury

Guatemala

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  • Liz Gordillo Anleu and Carlos Flores Presa, GUATEMALA - AUTHORIZATION OF THE NORM OF EXCEPTION OF LIABILITY AND COMPENSATION FOR SERIOUS ADVERSE REACTIONS ATTRIBUTED TO COVID-19 VACCINES (February 2021)
    • "COVID-19 vaccination is voluntary, universal, and free"
    • Manufacturers supplying the state "may only be responsible for intentional or severely blamed actions or omissions for non-compliance with their obligations of good manufacturing practices"
    • Committee on the Evaluation of Serious Adverse Reactions to Vaccines is established; five national experts w/ extensive experience in vaccination
    • "compensation system shall be determined through the care of the affected person, as needed, in the national health services network" (but no compensation if the person was injured due to their own fraud)

Hungary

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  • Braner Torsten, Can vaccination be made mandatory? (March 2021)
    • "In Hungary–and in most European countries–employers should not require their employees to be vaccinated or subject to sanctions if they are not vaccinated. The exception is health workers"
    • "Slovakia and the Czech Republic cannot oblige anyone to vaccinate because there is no legal basis for the obligation".
    • Austria allows unvaccinated workers to be refused workplace access or relocated, but must be paid full wage.

India

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Ireland

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  • Anne O’Connell, Covid-19 Vaccine and the Workplace– What is the Position for Employers and Employees (25th February 2021)
    • Article 40.3 of the Constitution of Ireland implies a right to bodily integrity; Article 8 of the European Convention on Human Rights provides for right to respect for private and family life
    • Employment Equality Acts 1998-2011 prohibits discrimination due to religion, age, gender (due to pregnancy) or disability
    • Safety, Health and Welfare at Work Act 2005-2014 requires employers to control workplace risks and employees to cooperate; "likely that employers could rely on this obligation in seeking employees to get vaccinated".
    • Data Protection/GDPR does not prohibit employer inquiries into reasons for refusing vaccinationAuthors – Anne O’Connell & Ethna Dillon
  • Mandatory COVID-19 Vaccines for Children? (Ireland, 19 March 2021) - Article 42A of the Constitution (enacted 2015) allows government intervention where parents "fail in their duty towards their children to such extent that the safety or welfare of any of their children is likely to be prejudicially affected"; has been held to cover refusal to consent to medical care.

Israel

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Italy

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  • Fabrizio Spagnolo, COVID-19: vaccination of employees and virus containment in the workplace
    • Decree-Law no. 44 of 1 April 2021 provides for workplace vaccination obligations
      • particularly for healthcare workers
      • unvaccinated can be moved to positions with lower risk of spread, even if the job functions pay less
      • if there is no place to move them, they can be put on leave without pay until 31 December 2021
    • Protocol signed 6 April 2021 by government, employers and trade unions allows for COVID-19 workplace vaccination cites for workers voluntarily seeking vaccination
    • Companies can also contract with private providers
    • Article 3 of Decree-Law no. 44 of 1 April 2021 "expressly exempts healthcare workers from criminal liability for adverse events"

Japan

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Netherlands

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New Zealand

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  • June Hardacre, Gillian Service, Megan Richards, NZ Covid vaccination and the workplace (NZ, 14 April 2021)
    • Ministry of Business, Innovation and Employment (MBIE) says that employers generally cannot require that employees be vaccinated, disclose vaccination status, or disclose reasons for not vaccinating.
    • May be exceptions for specific roles that must be performed by a vaccinated person (enclosed environments, working with vulnerable populations).
    • Employers may encourage, facilitate with on-site, lead by example by getting vaccinated

South Africa

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Turkey

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  • Orcun Cetinkaya, Baran Arslanargin, Import Duties for Human Vaccines are Zeroed in Turkey (March 24, 2021): Presidential Decree No. 3685, “Amending the Turkish Customs Tariff Schedule Divided into Statistical Positions", published in the Official Gazette (March 2, 2021), no. 31429 (Turkish only).

Ukraine

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UK

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  • Lucy Lewis, Colin Leckey, and Helen Coombes, COVID-19 vaccination – FAQs for employers (24 February 2021)
    • "Mandating vaccination for employees has never been tested in UK law"; unlikely to prevail in most cases
    • Employees "with over two years' service" are protected from dismissal
    • Employers "could in theory mandate the vaccination as a health and safety requirement" if an assessment showed it to be the most reasonable risk mitigation method, notes that "government is the largest employer in health and care settings and is not making the vaccination mandatory"
    • Discrimination claims can arise from lack of exceptions for "medical, pregnancy or belief reasons"
    • Safeguards make it hard for employers to require employee vaccination status
    • Standards should apply the same to contractors/agency workers/visitors
    • Health and Safety at Work Act 1974: must take reasonable steps to reduce any workplace risks
    • Incentivization "not properly tested under UK law"
    • Can employers provide the vaccine? Not now because only gov't is providing it; in the future, would be a taxable benefit if worth more than £50
    • Might limit workplace access to vaccinated
    • Needle phobia might be an issue, but "[m]ost individuals with such a phobia would probably struggle to bring themselves within the protected characteristic of disability for Equality Act purposes".
  • Anne-Marie Balfour, Covid-19 Vaccination – can an employer make it compulsory for employees? (17 December 2020)
    • Must ensure employee health and safety, but can't dismiss employees unfairly or for whistleblowing.
    • Genuinely held beliefs must be respected if "worthy of respect in a democratic society" and "not in conflict with the fundamental rights of others"; also can't discriminate base on disability, sex, pregnancy, maternity, age, ethnicity.
    • Mandates may harm employer reputation, implicate "sensitive personal data, which has strict protection under data protection laws".
  • Ruth Meyer, Best Interest Decisions: ‘Mental Incapacity and the Covid-19 vaccine’ (8 March 2021): Section 4 of the Mental Capacity Act 2005 requires a Deputy to make best interest decisions for unable unable to make their own decisions. Case is E (vaccine) [2021] BWCOP7, elderly woman with dementia and schizophrenia; son objected to COVID-19 vaccination. Judge noted that E was indeed incapable, but had previously received vaccines when she was capable, and would want to be vaccinated.
  • Kerrie Taylor, Covid-19: Further Court of Protection decision on the administration of the vaccine (April 14, 2021): CR is a 31-year-old autistic and otherwise disabled man; under s. 4(7) of the Mental Capacity Act 2005 the court must focus on the interests of the recipient. Court found that the vaccine should be administrated; noted in part that CR's father objected due to the debunked theory that the measles vaccine had caused CR's autism.
  • Douglas McGregor and Alison McAteer, COVID-19 Vaccines and Civil Liability (17 March 2021)
    • MHRA approves all UK vaccines. Regulation 46 of the 2012 Regulations prohibits "unauthorised" medicinal products, but Regulation 174 allows temporary authorisation in response to emergencies including "pathogenic agents" which "may cause harm to human beings". Regulation 345 immunizes involved parties (license-holder, manufacturer, their agents) from civil liability. Regulation 174A(3) of 2020 restores liability where there is a "sufficiently serious" breach of conditions of temporary authorization.
    • Regulation 345 of the 2012 also immunizes vaccine administrators.
    • Liability is not barred under Section 2 of the Consumer Protection Act 1987, for product defects (as opposed to side-effects of correctly manufactured vaccines).
    • In December 2020, the COVID-19 vaccine was added to list of vaccines covered by the Vaccine Damage Payments Act 1979 (recovery permitted for severe disability, defined as 60% or more).
    • Vaccine administrators may be liable for negligence if, e.g., they fail to take contraindications into account.
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