European Standards

ECO is trying to establish a European Standard in the care of babies born with clefts .  Product standards at national and European level have been around for decades and are universally understood and accepted (product kite marks, such as BSI in the UK and CE in Europe).  In recent years the European Standards Office in Brussels  has also been focusing  on service standards.  The European Commission has been keen to encourage this and over the past year CEN has been  expanding its work to cover aspects of healthcare service delivery. SEE UPDATE

 A European Standard in Aesthetic Surgery is currently being developed and  will be published by April 2012.  A proposal to develop a Standard for osteopaths is on the way.  At the end of last year ECO, set out a proposal to establish a European Standard in the early management of babies born with cleft lip and palate.  The aim is to try to address the huge inequality in cleft care across Europe (babies with clefts are still abandoned in some countries in Europe). 

 

Rationale for  European Standards in healthcare delivery

Effecting  pan-European change to healthcare practices through EU mechanisms and directives is a long, unwieldy process.   The development of a European standard aimed a particular service or health condition is relatively short - typically two to  three years from start to finish.  Moreover, Standards are usually written 'bottom-up' by experts in the field, comprising a mix of users and health professionals.  A  European Standard, once adopted, must be adopted as a national Standard in all EU and EFTA countries and Croatia, replacing any existing national standard. .  Whilst these standards are voluntary, in practice it becomes difficult for governments to ignore them.  Service directives can be formulated quoting the standards as a baseline level of service. Funding streams could be held back, for instance, until a particular government agreed to work towards a standard.  DG Sanco puts European health inequalities high on its agenda and if there is an agreed European Standard for  condition-specific healthcare delivery,  DG Sanco can use this  to bring about a reduction in inequalities.   Additionally, any potential funder  would welcome assurances that a grant given for a particular project would be spent on services that conformed to an agreed European Standard. 

The use of  European Standards to improve healthcare  also supports the “social innovation” agenda of the Commission and commission president.

See here: http://ec.europa.eu/social/main.jsp?langId=en&catId=89&newsId=445

and here http://ec.europa.eu/social/main.jsp?langId=en&catId=547

 

Translational benefits beyond Europe

Whilst the aim is to improve standards in Europe there may be some translational benefits to other parts of the world.  If workable standards are implemented in Europe, they may provide models that can be used elsewhere

 

Benefits in summary

  • Agreed baseline standard of care which can be used as a model throughout Europe
  • Consistency of approach facilitates measurement of health outcomes
  • Wittenby real experts - users and health professionals
  • Can be used by as an empowering tool, enabling patient groups to lobby for change   
  • Facilitates reduction of health inequalities and can be used to inform DG Sanco Directives
  • Supports Commission's Social Innovation agenda
  • Process forces development of new networks of health professionals and patient groups 
  • Standard can have translational benefits beyond Europe and be used as template by the International Standards Office (ISO),  meshing with relevant WHO Directives

 

The process

1)  A proposal is submitted to CEN in Brussels through one of the CEN member organisations (one of the national standards offices, e.g. BSI in the UK). 

2) CEN then sends the proposal to all Standards bodies in Europe who must consult with stakeholder groups in their country over a three month period.

 3) Voting then takes place and at least 5 countries must want to actively participate in developing the standard.  The process can be halted if any country voices a 'fundamental disagreement'.

 4)  Once the proposal has been accepted by CEN as being appropriate for a Europe wide standard,  a project committee is established comprising experts - a mix of health professional and users.. 

5) Once a draft standard has been agreed by the project committee it will be circulated by CEN to all national standards bodies for comment.  The received comments are then evaluated and a final draft version is compiled and circulated.  All offices will then have a weighted vote (based on population size) on the standard.

6) Once ratified,  the Standard must be adopted by all national standards bodies.

 

European Cleft Organisation

At the end of 2010 ECO submitted an application to the Bulgarian Standards Office (BDS) proposing that a European Standard is introduced spelling out  treatment pathways for all babies born with clefts.  These guidelines cover the period from diagnosis (pre or post natal) until the moment of  definitive surgery to repair the cleft.  ECO's own studies have shown that many babies are abandoned in parts of Europe because parents are given the wrong or misleading information about clefts at the time of diagnosis.   This proposal was in turn sent  to CEN in Brussels who finalised documentation for Europe-wide three-month consultation.  This began in early January 2011.

In April ECO learned that though this proposal had received wide support,  two countries (France and Spain) expressed concerns that a standard in cleft care might interfere with their own internal healthcare legislation.  They voiced 'fundamental disagreements' to the proposal which has effectively halted the process. We have now found out that in these countries neither patient groups nor cleft specialists were consulted by their national standards bodies (AFNOR and AENOR), contravening CEN's own guidelines on 'consulting with stakeholder groups.  We know that patient groups and health professionals in  France and Spain support our initiative.  It appears that both AFNOR and AENOR bowed to pressure from their own health ministries to reject the proposal without going through a wider consultation process.

What next?

ECO plans to continue undeterred and will re-launch the proposal later this year.  There will be some amendments and clarifications to the text of the proposal in response to some feedback we have received during consultation but its aims and scope will remain the same.

We will ensure that we target stakeholder groups ourselves in France and Spain during the next consultation process and demand that they write directly to AFNOR and AENOR in support of the proposal.

However, we see a need for support beyond our own immediate stakeholders as we feel that the process has been derailed by ministers and politicians.  We need to send strong messages of support to CEN which they can use in their own internal discussions with AFNOR and AENOR.  The development of European Standards for other health conditions may similarly be blocked if we do not address this now.