Last year Médecins Sans Frontières (MSF) refused free vaccinations for pneumonia from Pfizer, who had offered the medicines as a corporate donation to the humanitarian organisation. The explanation MSF provided (available here) makes for an interesting, if uncomfortable read. Looming large is the lengthy history of negotiations between MSF with the only manufacturers of the vaccine, GlaxoSmithKline and Pfizer. MSF claim that the only sustainable solution to a disease that claims the lives of almost a million children each year is an overall reduction in the cost of the vaccine, and not one-off donations that come with restrictions on where MSF may use the medicines, and a constant power disparity between the parties, where Pfizer may release the medication on their own timeline, and revoke access as they see fit.
It’s a rainy day on the East Coast; what better way to get through the damp than four new legal epidemiology articles? Our colleagues have published papers examining vaccine policies, telehealth reimbursement policies, scope of practice laws for health care providers, and the field of legal epidemiology as a whole:
Legal Epidemiology: The Science of Law
T Ramanathan, R Hulkower, J Holbrook, M Penn – The Journal of Law, Medicine and Ethics
The Latest in Vaccine Policies: Selected Issues in School Vaccinations, Healthcare Worker Vaccinations, and Pharmacist Vaccination Authority Laws
L Barraza, C Schmit, A Hoss – The Journal of Law, Medicine & Ethics
Legal Mapping Analysis of State Telehealth Reimbursement Policies
KE Trout, S Rampa, FA Wilson, JP Stimpson – Telemedicine and e-Health
Expanding Access to Care: Scope of Practice Laws
K Hoke, S Hexem – The Journal of Law, Medicine & Ethics
Since the 1990s, there has been a growing movement to improve access to immunization services by giving pharmacists the authority to administer vaccines.
The newest map on LawAtlas.org explores state laws from 1990 to 2016 that give pharmacists authority to administer vaccines and establish requirements for third-party vaccination authorization, patient age restrictions, and specific vaccination practice requirements, such as training, reporting, record-keeping, notification, malpractice insurance, and emergency exceptions.
As of January 1, 2016:
- Pharmacists were explicitly authorized to administer vaccines in 46 states and the District of Columbia.
- Thirteen states and the District of Columbia permit exceptions to vaccination requirements for emergencies or epidemics.
- Ten states grant pharmacists prescriptive authority to administer vaccines (i.e., pharmacists can vaccinate without a third-party authorization).
The dataset was created by Cason Schmit, JD, Research Assistant Professor, Texas A&M University, and Allison Reddick, JD, MPH, Associate Attorney at Hill & Ponton, PA.
Whether it is Ebola, H1N1, the season flu, or the next nasty bug that we cannot yet even imagine, if we wanted to efficiently spread the disease, one could not do much better than packing several hundred people into a cylinder for a few hours, while they eat, drink, defecate, and urinate. Even more, to make sure that the disease cannot be contained in a particular locality, we could build thousands of those cylinders and move them rapidly from one place to another worldwide, remix the people, and put them back in the cylinders for return trips back to their homes, schools, and jobs.
We are (hopefully) not going to stop airline travel. But we can make it a lot safer, by ensuring that almost everyone who boards these flights is vaccinated. That’s the thesis of a new paper out this week.
Airlines carry two million people every day. And, prior research has shown that airline travel is a vector of disease. In fact, when the September 11 attacks caused airline travel to fall, seasonal flu diagnoses fell too.
The threat of pandemics is quite real, and more generally, the mortality and morbidity associated with infectious disease is a severe public health burden. About 42,000 adults and 300 children die every year from vaccine-preventable disease. New vaccines are on the horizon.
Arguably, airlines have market-based and liability-based reasons to begin screening passengers, whether for vaccinations generally or for particular ones during an outbreak. Although the states have traditionally exercised the plenary power to mandate vaccinations, and have primarily focused on children in schools, the U.S. federal government also has substantial untapped power to regulate in this domain as well.
By George Maliha, Harvard Health Law Society
As flu season begins, we are bombarded by ubiquitous reminders to get our flu shot. So, it is a good opportunity to reflect on how we provide vaccines to our fellow citizens 65 and older. By law, Medicare Part B covers 4 preventive vaccines (flu, two pneumococcal, and hepatitis B for medium-to high-risk patients). Part D picks up the rest, namely shingles, TDaP, and any other commercially available vaccine. But, that’s where the trouble begins.
When Congress passed Part D, the vaccines recommended for those 65 or older were basically covered by Part B. Now, they aren’t. In 2006, the zoster (or shingles) vaccine came onto the market. In 2010, the recommendations for the TDaP (the P for pertussis or whooping cough being the most relevant here) changed to include the elderly.
But, so what, they’re still covered, right? Continue reading
This week, the Supreme Court appropriately declined to hear an appeal of a 2nd Circuit decision upholding the right of the state to require vaccination as a condition of enrollment in public schools, and to exclude exempted children from attending school during an infectious disease outbreak.
Under the Constitution, states have police power to protect the public’s health, welfare, and safety. A long-standing use of this authority is to protect communities from risks related to vaccine-preventable illnesses. In addition, when an infectious-disease outbreak occurs, states may use their police power to interrupt further transmission of the disease by restricting the movement of individuals. All states have incorporated this concept of social distancing into their school immunization laws. Schools can prohibit an unvaccinated child, who is more susceptible to acquiring highly infectious vaccine-preventable illness and more likely to become a carrier and vector for it, from coming to school until the danger subsides. Such measures, coupled with ready availability of vaccines, reduce the potential spread of serious disease in a vulnerable and tightly packed community. Continue reading
I’ve started writing for Forbes as a regular contributor. My first piece, Carly Fiorina Says Her Views On Vaccines Are Unremarkable; For Better Or Worse, She’s Right, analyzes GOP presidential candidate Carly Fiorina’s recent ad hoc remarks on the relative rights of parents and schools with respect to vaccinations and to some of the hyperbolic reactions to those remarks. Fiorina’s remarks are ambiguous, in ways that I discuss. But, as the title of the article suggests, and for better or worse, I think that the best interpretation of them places her stance squarely in the mainstream of current U.S. vaccination law. I end with a call for minimally charitable interpretations of others’ views, especially on contentious issues like vaccination.
By Wendy Parmet
Australia’s recently announced “no jab, no pay” policy offers a potent reminder of the all-too-common tendency to penalize vulnerable populations for public health problems. Like many other countries, Australia has experienced a worrisome increase in the number of families deciding not to vaccinate their children. In response, the government of Prime Minister Tony Abbott has announced a program of carrots and sticks. The carrots include increased payments to physicians to incentivize them to urge families to vaccinate their children. The sticks include tightening the religious exemption (Australia does not provide an exemption for personal belief) and the “no jab, no policy” which will deny families whose children aren’t vaccinated certain income-based childcare and family tax benefits.
Governments have long used the denial of public benefits – traditionally public education – to push parents to vaccinate their children. Studies have shown that laws conditioning attendance in schools and daycares on vaccination can increase vaccination rates, although the particular formulation of the law (especially how difficult it is to receive an exemption) matters.
To be sure, laws that require children to be vaccinated to attend schools or daycare impose heavier burdens on poor families who are more apt to need daycare and are less able to homeschool their children. Still, these laws reach broadly, especially when they apply to private schools. Homeschooling remains relatively rare. Significantly, school-based vaccine laws do not single out low-income families. Continue reading
Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology & Global Health Policy, University of California, Irvine School of Law
In a previous post, I discussed three possible methods of increasing vaccination and decreasing vaccine refusals in the United States. One of these options was using tort law and allowing lawsuits against parents for refusing/failing to vaccinate their children. The Pakistani government has recently taken it one step further, arresting and issuing arrest warrants for parents refusing to vaccinate their children against polio. Last week, approximately 512 people, 471 in Peshawar and 41 in Nowshera, were arrested and jailed and arrest warrants were issued for 1,200 more parents for refusing to vaccinate their children.
Currently, the government allows parents to be released from jail and return home if they sign an affidavit promising to vaccinate their children. Despite the fact there is no law requiring polio vaccination, some view the recent crackdown as “a blessing in disguise” for unvaccinated children. This drastic approach responds to high rates of refusal, a contributing factor to Pakistan’s significant number of polio cases. According to the World Health Organization, in the period since March 2014 Pakistan registered 296 polio cases, the most in the world and drastically higher than even the second-highest rate of 26 cases registered by Afghanistan. Why is Pakistan’s vaccination rate so low? For many reasons, including religious beliefs, attacks on medical workers, displacement of individuals due to ongoing military operations, and a lack of trust in health care workers and the vaccine. Continue reading
There are lots of reasons why measles, having gone to Disneyland, is enjoying a comeback around the United States and Canada. Unfounded fears of autism scare some parents. Others buy the daffy conspiracy theory that pharmaceutical companies are just pushing vaccination to make a buck. Some parents invoke religious concerns despite that fact that hardly any religions think vaccination is bad and most teach that it is an obligation in order to protect children and the vulnerable in the community.
One key reason behind falling vaccination rates is that if you believe any of the above untruths it is very easy to get an exemption. Most states let you out on religious or philosophical grounds. Every state excuses you or your kids for health reasons. So you might presume those ducking vaccines get approval to dodge vaccination from physicians. Uh uh. In 17 states, D.C. and Puerto Rico naturopaths, healers who believe in a mishmash of nutritional medicine, botanical medicine, naturopathic physical medicine including chiropractic manipulative therapy, rolfing, iridology, and homeopathy among other New Agey philosophies can get licenses in their state. There are thousands practicing in the United States. Put aside the issue of why states are recognizing these ‘healers’ who rely on an evidence base only a few steps above astrology and palm-reading. The fact is in many states a naturopath can excuse a child from vaccination. And since many naturopaths take a pretty dim view of vaccination they give a lot of exemptions. […]
Read the full article here.
By Allison M. Whelan (Guest Blogger)
For many years now, there has been ongoing debate about childhood vaccinations and the recent measles outbreak in Disneyland and its subsequent spread to other states has brought vaccinations and questions about communicable diseases back to the headlines. Politicians, including potential presidential candidates such as Hilary Clinton, Rand Paul, and Chris Christie, are also wading back into the debate.
Most recently, five babies who attend a suburban Chicago daycare center were diagnosed with the measles. As a result, anyone in contact with these infants who has not received the MMR (measles, mumps, rubella) vaccine must remain home, essentially quarantined, for the next twenty-one days—the incubation period for measles. All five of these infants were under the age of one and therefore did not yet have the chance to receive the vaccination, which is not administered until one year of age.
The Chicago outbreak is a prime example of why public health officials emphasize the reliance on herd immunity to protect those who are not yet, or cannot be, vaccinated for legitimate reasons. Unfortunately, the United States has reached a period where it can no longer place much reliance on herd immunity, particularly as more parents decide not to vaccinate their children against very contagious, yet highly preventable diseases. Illness and death are two of life’s certainties, but why should they be given that they are preventable in this situation? What are the strongest, most rational arguments in this debate? What policy solutions should states consider? Several options have been proposed over the years, some more feasible and likely than others. Continue reading
By Timo Minssen
The current Ebola outbreak already attracted much attention on “Bill of Health” resulting in some excellent blogs on a horrible topic.
While it is evident that the current health crisis requires both immediate responses and more sustainable changes in health care policy, research and regulation, medicines regulators are collaborating internationally to find innovative solutions enhancing evaluation of and access to potential new medicines to fight Ebola outbreaks. In a statement announced by the International Coalition of Medicines Regulatory Authorities (ICMRA) in September 2014, regulators around the world led by the FDA and the EMA have vowed to collaborate in supporting accelerated evaluation of experimental new drugs to treat Ebola virus infections and say they will encourage submission of regulatory dossiers. This clearly backs up the World Health Organization’s (WHO) decision to test experimental Ebola treatments in infected patients in the current outbreak region in West Africa and to speed up the development of vaccines.
In the following I would like to summarize and discuss some of the recent European responses to the current crisis starting with an overview on recent initiatives at the EMA.
Like its US counterpart, the EMA leads a close and consistent dialogue with public and private developers of Ebola products and spends much effort in reviewing available information on the various experimental Ebola treatments currently under development. These experimental drugs range from experimental antivirals or vaccines based on the adenovirus or stomatitis vaccine to experimental therapies based on mono- and polyclonal antibody technologies. One of these unapproved antibody combination drugs – MAPP Biologicals’ ZMapp – has already been used in some care workers affected by Ebola. Other experimental drugs that are currently reviewed by the EMA include Biocryst’s BCX 4430, Fab’entech’s Hyperimmune horse sera, Sarepta’s AVI-7537, Toyama Chemicals and MediVector’s Favipiravir and Tekmira’s TKM-Ebola.
In addition to monitoring experimental drugs and enhancing global collaboration, the European Medicines Agency has like the FDA initiated several activities in order to support and speed up the development of these drugs towards market approval. Continue reading
Fairbanks School of Public Health and McKinney School of Law, Indiana University, Indianapolis.
This has been a big year for outbreaks of Vaccine-Preventable Illnesses (VPIs) in the United States. While we are only halfway through 2014, there have been more measles cases this year than we have seen since before 2000, when the Federal government officially declared the United States “measles free” (in other words: there are no more domestically-generated measles cases; all of our outbreaks are imported). We’ve also seen large mumps and whooping cough outbreaks. You can follow all the disease outbreak action, both here and worldwide, via the Council on Foreign Relations’ very cool interactive map.
States use their police power authority under the Constitution to try to minimize our risk of exposure to VPIs. First, every state requires that children demonstrate proof of immunization against many VPIs as a condition of entry into schools, preschools and day cares. States also permit exemptions to these laws – every state allows a child who may be medically susceptible to injury from vaccines to receive an exemption (with proper documentation of vulnerability), and most states allow parents to apply for an exemption based on either religious or broader philosophical grounds. A combination of factors, including: a nearly two decade trend of increasing numbers of families obtaining exemptions and clustering in particular communities (or avoiding vaccine requirements by taking advantage of law loopholes, such as if a state’s vaccine law does not cover private schools); waning effectiveness of vaccination protections over time (as has been seen with whooping cough); increased international travel facilitating ready reimportation of VPIs from abroad; and many more immunocompromised individuals living in our communities; have slightly weakened our overall protection against VPI outbreaks. Continue reading