Showing posts with label legal liability. Show all posts
Showing posts with label legal liability. Show all posts

Tuesday, 14 September 2021

What’s the law on vaccine exemptions? A religious liberty expert explains

‘Many schools, businesses and governments requiring vaccination have offered religious exemptions. Some are loath to challenge people’s claims that getting the shot goes against their beliefs for fear of being sued, but organizations have come up with a variety of ways to assess claimants’ sincerity. But the legal basis of Americans’ supposed right to a religious exemption to vaccination is less clear than such policies’ popularity would suggest.

‘As a lawyer and scholar who focuses on religious liberties, I have supported religious exemptions for a baker who refused to create a cake for a same-sex wedding, a family-owned business that refused to provide emergency contraception to its employees, a Muslim prisoner who was obligated to grow a beard and many others.

‘Even so, I believe that under the general law of religious liberty – including the Constitution and state and federal religious freedom laws – the government has an easy case to refuse religious exemptions from vaccines against infectious disease.’

Read here (Religious News Service, Sept 15, 2021)

Wednesday, 10 February 2021

How to manage vaccine liability in Malaysia

‘While different systems vary in terms of elements of compensation and funding mechanisms, we can adapt the policies related to funding, proving injury and distributing compensation involving multiple parties. For example, we can set up a bespoke Covid-19 vaccine compensation programme. The programme could be co-financed by a mixture of public and private funds (eg. led by insurers), to achieve effective immunisation roll-out while providing a fair and equitable remedy and reduce overall costs to society.  

‘Two, Malaysia’s government can adapt the Singapore model and completely assume the financial costs of any serious adverse events from the vaccine. The list of serious adverse events that are covered, the mechanism of approval and the ministry which will pay are details that can be decided by a relevant committee. Given serious adverse events are rare, the overall cost should be manageable and represents a good investment for public confidence.

‘A third option is the Covax Facility’s no-fault-compensation scheme for indemnification and liability. The scheme proposed by Covax aims to set up a compensation fund for vaccine recipients in participating countries who might suffer any side-effects from COVID-19 vaccines. The scheme proposes a new mechanism to pay a lump-sum based on severity of harm to victims from Covid-19 vaccines associated side effects. The proposed mechanism would be funded by earmarking funds from high income countries or by charging taxes on pharmaceutical companies.  

‘There are reasonable solutions to the problem, and Malaysia must have a full-frontal and honest conversation about how to manage adverse events, no matter how unlikely they might be. All the solutions described above are not mutually exclusive. However, implementing them requires political will and courage. Covid-19 vaccination is a collective national effort, and we must do all we can to increase public confidence in the vaccine by providing appropriate liability protections.’

Read here (Malay Mail, Feb 11, 2021) 

Thursday, 4 February 2021

Covid-19: Social murder, they wrote — elected, unaccountable, and unrepentant

‘After two million deaths, we must have redress for mishandling the pandemic... Murder is an emotive word. In law, it requires premeditation. Death must be deemed to be unlawful. How could “murder” apply to failures of a pandemic response? Perhaps it can’t, and never will, but it is worth considering. When politicians and experts say that they are willing to allow tens of thousands of premature deaths for the sake of population immunity or in the hope of propping up the economy, is that not premeditated and reckless indifference to human life? If policy failures lead to recurrent and mistimed lockdowns, who is responsible for the resulting non-covid excess deaths? When politicians wilfully neglect scientific advice, international and historical experience, and their own alarming statistics and modelling because to act goes against their political strategy or ideology, is that lawful? Is inaction, action?1 How big an omission is not acting immediately after the World Health Organization declared a public health emergency of international concern on 30 January 2020?

‘At the very least, covid-19 might be classified as “social murder,” as recently explained by two professors of criminology. The philosopher Friedrich Engels coined the phrase when describing the political and social power held by the ruling elite over the working classes in 19th century England. His argument was that the conditions created by privileged classes inevitably led to premature and “unnatural” death among the poorest classes. In The Road to Wigan Pier, George Orwell echoed these themes in describing the life and living conditions of working class people in England’s industrial north. Today, “social murder” may describe the lack of political attention to social determinants and inequities that exacerbate the pandemic. Michael Marmot argues that as we emerge from covid-19 we must build back fairer...

Getting redress

‘Where then should citizens turn for accountability, if they don’t find it in their leaders and feel unsupported by experts and the media? The law remains one form of redress, and indeed some legal avenues, including criminal negligence and misconduct in public office, are being explored, although proving any such claims will be difficult and drawn out. But the notion of murder, at least “social murder,” is hard to shake emotionally, and strengthens with every denial of responsibility and every refusal to be held accountable or to change course.

‘That leaves three options. The first is to push for a public inquiry, as The BMJ and others argued for in the summer of 2020—a rapid, forward looking review rather than an exercise in apportioning blame that will identify lessons and save lives. The second is to vote out elected leaders and governments that avoid accountability and remain unrepentant. The US showed that a political reckoning is possible, and perhaps a legal one can follow, although research suggests that mishandling a pandemic may not lose votes.21 The third is for mechanisms of global governance, such as the International Criminal Court, to be broadened to cover state failings in pandemics...

‘The “social murder” of populations is more than a relic of a bygone age. It is very real today, exposed and magnified by covid-19. It cannot be ignored or spun away. Politicians must be held to account by legal and electoral means, indeed by any national and international constitutional means necessary. State failures that led us to two million deaths are “actions” and “inactions” that should shame us all.’

Read here (British Medical Journal, Feb 4, 2021)

Monday, 4 January 2021

Peter Doshi: Pfizer and Moderna’s “95% effective” vaccines—we need more details and the raw data

Peter Doshi: Pfizer and Moderna’s “95% effective” vaccines—we need more details and the raw data 

‘Five weeks ago, when I raised questions about the results of Pfizer’s and Moderna’s covid-19 vaccine trials, all that was in the public domain were the study protocols and a few press releases. Today, two journal publications and around 400 pages of summary data are available in the form of multiple reports presented by and to the FDA prior to the agency’s emergency authorization of each company’s mRNA vaccine. While some of the additional details are reassuring, some are not. Here I outline new concerns about the trustworthiness and meaningfulness of the reported efficacy results...’

Read here (BMJ, Jan 4, 2021) 

Sunday, 27 December 2020

Covid-19 vaccines for Malaysia: A call for transparency in registration & purchasing

By Citizens’ Health Initiative (citizenhealthinitiative@gmail.com)

With the exception of the People’s Republic of China and a few other countries like New Zealand, Vietnam, Cuba, Senegal, and Kerala state in India, which seem to have largely brought Covid-19 under control without the help of vaccines, most countries are struggling with succeeding waves of the pandemic and a likely global spread of a more contagious mutant of SARS-CoV-2.  

The collateral damage to economic and social well-being worldwide has been unprecedented, and it underscores the urgently felt need for vaccines and a return to some semblance of normalcy.

Despite a major lapse with a 16,000 plus person religious gathering which erupted into several clusters locally and in the region (March 2020), Malaysia had performed creditably earlier.

Sources of current outbreaks

Unfortunately, since October 2020, a resurgence of clusters emerged from non-compliant returnees from abroad, and porous Sabah state border controls, exacerbated by lax enforcement of SOPs during the September 2020 Sabah state elections. 

Immigration and health authorities were not sufficiently pro-active to prevent its further spread in the peninsula, resulting in numerous outbreaks, especially among workers in congested accommodations and workplaces, and in prisons and detention centres.

Unlike Singapore’s experience with outbreaks in migrant dormitory complexes, we in Malaysia are additionally reaping the consequences of decades of corrupt mismanagement of labor migration, viz. a persistently large pool of undocumented migrant workers (currently estimated at 1.2-1.5 million) who have strong incentives to avoid contact with government agencies.   

Senior Minister Ismail Sabri’s disastrous U-turn in going after undocumented migrants (after initially promising them sanctuary and no arrests and deportation during the pandemic) greatly complicated pandemic control efforts, in particular the crucially important contact tracing.

As generally younger daily-paid workers, more likely to ride out the milder symptoms of Covid-19 infection, they are now even less inclined to cooperate in testing and isolation, given the risks of arrest, detention and deportation.

\We thus face the prospect of protracted and repeated seeding of the general population by the asymptomatic or mildly symptomatic, especially undocumented workers reluctant to seek treatment unless severely ill. (We should also note that active avoidance of contact tracing and testing involves others disinclined to divulge network contacts or contact history, e.g. underworld elements, drug and sexual encounters, etc).

As in many other countries, many Malaysians support efforts to secure vaccines to enhance pandemic control efforts.

Procuring vaccines for Malaysia

The minister for Science, Technology, and Innovation Khairy Jamaluddin has announced commitments to purchase a basket of Covid-19 vaccines, and options for further orders .

Khairy Jamaluddin needs to be transparent about the technical rationales, criteria, and pricing for his ministry’s purchasing decisions.  In particular, he needs to respond to very pertinent points raised by the Covid Research Centre (KL) , chest specialist Dr Jeyakumar Devaraj , and others, which include the following:

  • there is currently little information on long-term safety beyond 2 months or on durability of protection, for all candidate or approved vaccines (any late-manifesting adverse effects will only be detected by conscientious follow-up surveillance, monitoring, and reporting systems).  This is especially pertinent for novel mRNA vaccines, in comparison with the more familiar inactivated whole-virus vaccines with which we have decades of experience
  • the decision by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) to grant immunity to Pfizer from legal liability for late-manifesting adverse effects, and the Pfizer CEO declining to be among the early vaccinees (claiming selflessness in prioritising those more vulnerable, in contrast to some vaccine researchers who vaccinated themselves even before phase 1 human trials) perhaps reflects the true risk perception or assessment of the pharmaceutical corporations (whose profitable research and development work has been highly subsidised by governments for ‘vaccine nationalist’ reasons)
  • stringent logistic requirements (deep-freeze or ultra-low temperature facilities) for the mass deployment of mRNA vaccines to under-served remote areas
  • one additional advantage of the inactivated whole-virus vaccine is that the host immune response is mounted against a spectrum of antigens from the whole virus, rather than against a much more limited array of antigenic sub-components of say, the spike protein.  This could provide some insurance against mutations, say in the coding sequences for the spike protein, which might render vaccines directed solely against the spike protein wholly or partially ineffective.

Beyond the immediate urgency of securing access to adequate quantities of safe, efficacious and affordable vaccines, the larger question of our continuing dependency on foreign vaccine developers, producers and suppliers remains unaddressed.

National capabilities in production of medicines and vaccines

Consider Cuba, a nation of 12 million citizens hamstrung by a 60-year economic blockade by the US, which has invested in human and material resources to become a biotech power-house:  recombinant hepatitis B vaccines, synthetic polysaccharide vaccine against Haemophilus influenzae type B , CIMAvax vaccine against lung cancer , and innovative treatment of diabetic foot ulcers.

Cuba’s repeated offers of scientific collaboration in R&D, and joint ventures to position Malaysia as a regional production and distribution platform for Southeast Asia , have elicited only a lukewarm response.  Tan Sri Dr Abu Bakar Suleiman, the retired Director General of Health, has shown greater foresight and entrepreneurial verve as chairman of Bioven , which is shepherding CIMAvax through US-FDA and UK phase 3 clinical trials .

It is not too late to make the necessary strategic decisions for a promising growth area (pharmaceuticals and vaccines) in the national and regional economies of the newly launched RCEP.

For more information/clarifications, please contact:

  • Chan Chee Khoon     cheekhoon50@gmail.com 
  • Chee Heng Leng        cheehengleng@gmail.com 

Endorsers

  • Aliran
  • Citizens’ Health Initiative
  • Freedom
  • Kuala Lumpur & Selangor Chinese Assembly Hall (KLSCAH) 
  • Malaysian Physicians for Social Responsibility (MPSR)
  • North South Initiative
  • Pengguna Pahang
  • Parti Sosialis Malaysia (PSM)
  • Pergerakan Tenaga Akademik Malaysia (GERAK)
  • Suara Rakyat Malaysia (SUARAM)
  •  Childline Foundation

Monday, 14 December 2020

Whose liability for Pfizer’s vaccine?

‘The well-known The Independent newspaper reports that the United Kingdom Department of Health and Social Care has confirmed that Pfizer required, and has been given, an indemnity by the government, protecting it from legal action if any ill-effects arise from the dispensation of the vaccine.

‘What does this mean? What is the effect in law of such an indemnity? Simply, that the country that provides the indemnity becomes primarily and independently liable if anything goes wrong with the uptake of the vaccine.’

Read here (The Sun Daily, Dec 14, 2020)

Friday, 4 December 2020

Tucked into the Covid-19 stimulus package? Protection for corporations

‘US Representative Alexandria Ocasio-Cortez has been one of the few Democratic lawmakers to spotlight what’s really going on. Last week, she tweeted: “If you want to know why Covid-19 relief is tied up in Congress, one key reason is that Republicans are demanding legal immunity for corporations so they can expose their workers to Covid without repercussions.”

‘The bipartisan initiative aims to obscure its Dr Evil level of depravity by superficially depicting the liability shield as merely temporary. But that seems like a ruse, as indicated by private equity mogul and senator Mitt Romney of Utah, who said the federal Covid-19 liability shield provision “provides a temporary suspension of any liability-related lawsuits, state or federal level associated with Covid-19, giving states enough time to put in place their own protections”.’

Read here (The Guardian, Dec 5, 2020)

Thursday, 14 May 2020

‘A license for neglect.’ Nursing homes are seeking — and winning — immunity amid the coronavirus pandemic

‘Consumer advocates, industry watchdogs and personal injury attorneys say that providing legal immunity to thousands of private companies is dangerous. They contend the pandemic has exposed longstanding problems in the industry, such as staffing shortages and infection control violations, and that taking away its legal liability will make it harder to hold facilities to account now and in the future.’

Read here (Time, May 14, 2020)

Worst ever Covid variant? Omicron

John Campbell shares his findings on Omicron.  View here (Youtube, Nov 27, 2021)