A proposal for increasing EU cooperation on vaccination, published by the European Commission on 26 April, contains some surprisingly ambitious ideas. The stated aim of proposal is to foster a levelling upwards of vaccination coverage so that, in the words of Commission President Jean-Claude Juncker, “no child anywhere in the EU dies of a vaccine preventable disease”.
Much of the policy analysis accompanying the proposal focuses on “vaccine hesitancy”: people avoiding getting themselves or their children vaccinated, often due to fears about vaccine safety. The Commission has some interesting ideas on this. However, even more interesting, is its analysis of vaccine supply problems and its proposals for addressing these – particularly regarding development of new vaccines. Might these be a glimpse of future EU policy in the area of other pharmaceutical products such as medicines? Or will the proposal have its guts ripped out by Member States as soon as it gets to the Health Council?
The publication date for the Commission’s proposal was auspicious. It came out during European Immunization Week 2018, which runs 23-29 April. The World Health Organization’s (WHO’s) Regional Office for Europe has been running this annual campaign since the mid-2000s, initially as a way to eliminate measles from the European Region. The Americas Region of WHO had eliminated measles in 2002. If Paraguay, Brazil and Mexico could stop endemic transmission of measles in their countries what was to stop France, Germany and Italy doing the same? Quite a lot, as it turned out. The WHO European Region, which stretches from Lisbon to Vladivostok and covers 53 countries, missed deadlines of 2010 and then 2015 for eliminating measles. Not only that, but Europe exported so many measles cases to the Americas that the virus became endemic again there. Most of the fault for this failure lay with the numerous EU Members States, including France, Italy, Germany and the UK, where the percentage of children receiving two doses of measles vaccine was too low to stop the virus causing periodic outbreaks.
The failure of EU countries to eliminate measles is not just embarrassing. It comes with a cost in terms of illness, deaths and hospital fees (people with severe illness from measles can spend weeks or months in intensive care). In 2017, EU countries reported nearly 15,000 cases of measles. This lead to 37 deaths in 2017: 26 in Romania, 4 in Italy, 2 in Greece and one each in Bulgaria, France, Germany, Portugal and Spain. A further 7 measles related deaths have been reported so far in 2018. (all figures from ECDC rapid risk assessment on measles in EU, March, 2018).
Why are so many children and young people in the EU unvaccinated against this deadly disease? In Romania many of the unvaccinated are in the Roma community. The health system has, in the past, found it difficult to connect with the Roma. This continues to be the case for some parts of this community. However, in the richer EU countries like France, Italy, Germany and the UK the big problem has been “vaccine hesitancy” among middle class parents. Economically secure, reasonably well-educated people are making an active decision not to get their children vaccinated against measles. They have a mixture of motives for this. Some believe it is healthier for their children to be infected with measles and develop “natural immunity” than to acquire immunity through vaccination. Others believe in a link between the measles vaccine and autism. This rumour is based on speculation in one scientific paper published in the UK in the 1990s. Even though that paper and its author, Dr Andrew Wakefield, have been thoroughly discredited since then, the rumour persists. Unfortunately, though, the internet and social media are full of misinformation, pseudoscience and conspiracy theories about the supposed dangers of vaccination.
Changing people’s beliefs, perceptions and behaviour in notoriously difficult. It requires more than just publishing authoritative scientific information, or conducting yet another large scale study that finds no link between measles vaccines and autism. In recent years, public health communicators have started using some of the techniques of the anti-vaccine movement. With the consent of the people involved, they have posted heart rending video-clips telling the stories of children left brain damaged by measles (click here for example). This and a range of interventions, like more proactive follow up with parents of unvaccinated children and catch-up vaccination programmes for teenagers who did not get the vaccine as children have helped the UK and Germany raise their vaccine coverage over the past few years. A 2017 law in Italy making measles vaccination compulsory for children enrolling in state schools also seems to have had a positive impact – though it is possible the incoming Italian government may repeal the law.
In its proposal and the accompanying policy documents, the Commission makes a convincing case of how it can support Member States in raising uptake of existing vaccines, such as the Measles, Mumps and Rubella vaccine. There are innovative initiatives in many Member States, so there is certainly a role for the Commission in facilitating exchange of best practice and new ideas. There is certainly a need for more research on vaccine hesitancy and the factors that influence people’s decisions around vaccination. The EU’s research programmes can and should fund some of this research. Convening an EU-level stakeholder Coalition for Vaccination, as the Commission proposes, should be helpful. And most intriguing of all (to me at least) is the idea of conducting regular survey’s on the State of Vaccine Confidence in the EU. If the Commission can find a credible way of measuring and comparing vaccine confidence (several big ifs there…) this will be a valuable tool for assessing the impact of communication initiatives by Member States and other players (e.g. vaccines producers).
Another issue addressed by the Commission’s proposal is ensuring a steady and secure supply of vaccines. Manufacturing vaccines is a highly specialised and highly regulated business. For many vaccines there are just a handful of producers worldwide. The Commission notes there has disinvestment in production in the EU, possibly due to market fragmentation and unpredictable demand. The Commission offers support to making procurement and forecasting of demand more efficient – for example, by creating a virtual data warehouse on vaccine needs and stocks. The “virtual data warehouse” can help create a virtual EU stockpile of key vaccines to buffer Member States against supply shortage: this could possibly progress into being a real stockpile. Beyond this, though, the Commission seems to be proposing a bargain between Member States and the industry. The memo accompanying the Commission’s proposal notes that vaccination currently represents only 0.5% of healthcare budgets in the EU, and this percentage seems to be decreasing. However, “spending on vaccination should be regarded as an essential and smart investment in health, given its broader economic impact and societal value.” The underlying assumption seems to be that renewed political commitment to invest in vaccines and vaccination programmes by Member States will lead to new investment in production capacity by the industry.
The area where the Commission’s proposals are most intriguing is on development of new vaccines. It proposes developing “a roadmap of unmet population needs and agreed priorities for vaccines” to inform both EU and national research spending. There could also be “early dialogue with [vaccine] developers, national policy makers and regulator” to fast track authorisation of innovative vaccines relevant to emerging health threats. This looks like EU public health officials playing rather a hands-on role in identifying and supporting the research agenda for industry. With these same health officials complaining that spending on medicines is too much driven by what the industry offers, and not enough by what the public health system needs, might this be a glimpse of future EU pharmaceutical policy?
The Commission’s proposal needs to be debated and agreed by EU health ministers before it becomes a formal EU Recommendation. The European Parliament plenary in April adopted a resolution on vaccine hesitancy and the drop in vaccination rates in Europe and may also wish to give an opinion on this Recommendation. A number of ideas in the Recommendation, such as creating a common EU vaccination card and a common EU vaccine schedule have been discussed before in Council, notably during the Hungarian EU Presidency in 2011. They were, and no doubt still are, strongly opposed by a number of Member States, including most notably Germany. The Commission would like the Council to adopt the Recommendation by the end of 2018. It is by no means certain this will happen.