Ian Youngman from IMTJ examines the new European Union Provision of Services regulation and the implications for medical tourism agencies and facilitators operating within the EU. The new regulations may also have an impact on companies based outside of Europe but dealing with healthcare providers within Europe.
If you are involved in medical tourism, particularly if you are based outside of Europe, you may not bother too much with details of new European directives. But as anyone involved in producing or selling any health products around the world will tell you, EU legislation tends to be the benchmark that many countries outside of the USA follow.
EU regulations that affect daily what businesses around the world do, tend to appear quietly and without much fuss, as they are the ones that all EU countries agree on. The new regulations on services will affect many medical tourism businesses.
There are many people and companies in medical tourism charging other businesses for services or charging customers for acting as their agents. Many of these companies and individuals do not call themselves agents, preferring other names such as facilitator or consultant. But what you call yourself does not matter as far as these new rules are concerned.
The EU Provision of Services Regulations
In December 2009 a new European directive came into force which applies to the majority of business to business or consumer services businesses. The main bulk of the regulation concerns what information you must provide your customers with, the way you handle complaints and who you can and cannot refuse to offer services to. This article covers key points only. Individually enacted country laws will have some differences in detail and there is nothing to stop any country using these regulations as a base to impose much wider services regulation for businesses in their own country.
Do the regulations apply to your business?
The Provision of Services Regulations 2009 apply to most businesses that provide some form of service to another company or individual in exchange for payment. Consultants, accountants, lawyers, estate agents, and travel agents, are all examples of professions that fall within the remit of the directive. The directive does not list included professions; businesses and professions that are not excluded are automatically included.
There are some exceptions such as businesses in the financial services sector, transport providers and healthcare services. The regulations do not apply to the manufacture or sale of goods.
The regulations apply whether or not you do business just in your own country or across borders in any of the states in The European Union.
Some examples of where the regulations apply:
Business services: management consultancy; professional services such as lawyers; advertising; certification and testing; training providers; and the services of commercial agents.
Services provided to both business and to consumers: estate agents and the organisation of trade fairs.
Consumer services: tourism, including tour operators and tour guides; travel agents; and beauty services
Do the regulations apply to health/ medical tourism?
Healthcare services, whether or not they are provided via healthcare facilities, and regardless of the ways in which they are organised and financed at national level, or whether they are public or private are excluded
So it is clear that healthcare services provided in a hospital or clinic, and any treatment or advice, is excluded.
But the healthcare exclusion is only aimed at those organizations directly providing the healthcare, NOT to agents or other intermediaries.
Interpreting EU regulations can be a full-time job. EU regulations are always written to be as inclusive as possible. You can argue against interpretations, as long as you have years to spare and money to burn on legal fees.
This author’s view is that the regulations will apply to any health tourism agent whatever they call themselves, if they either take money from a patient and/or a hospital.
I believe that the regulations apply to the type of services, not the type of service provider. So it is highly likely that the rules apply to non-medical services offered by hospitals and clinics when they charge medical tourists and their companions for food, accommodation, travel, translation and other services.
What do you need to do to comply?
You will need to observe certain requirements about the provision of information to service recipients, the handling of complaints, and principles of non-discrimination within general conditions. The aim of these requirements is to ensure that service recipients have access to a minimum amount of information and to a complaints procedure. This should enable recipients to make more informed decisions when considering whether to buy services from a particular provider. The following requirements are, in general, already common practice in terms of information that should be provided:
The name of your business.
Your legal status and form (for example, whether you are a sole trader or limited company).
The geographic address at which you are established and details by which you may be contacted rapidly and communicated with directly and, if you can be contacted by electronic means, the relevant e-mail address.
If you are subject to an authorisation scheme, the relevant authority.
If you are carrying on a regulated profession, any professional body or similar institution with which you are registered.
The general terms and conditions that you use.
The existence of contractual terms, if any, that you use concerning the competent courts (for example, that the English courts have jurisdiction) or the law applicable to the contract (for example, that it is governed by English law).
The existence of an after-sales guarantee, if any, not imposed by law.
The price of the service, where a price is pre-determined by your business for a given type of service.
The main features of the service
You must make this information available without the customer or potential customer having to contact you for it. You must make it easily accessible on your website and in any information documents you supply to the recipient, which set out a detailed description of the service you provide, whether these are in a printed leaflet or supplied by e-mail. If you supply the information by phone you should follow up any serious service request with a written/emailed document including the information above.
You must also make available contact details where recipients can request information or make a complaint. This must include a telephone number and postal address.
You are also prohibited from refusing to provide your services on the grounds of a customer’s location unless you can justify this with ‘objective criteria’ such as the extra costs involved in providing a service that is too far from your business base.
Information you must supply if asked
You must supply the following information if the recipient asks for it (you may choose to make this information available in all cases if you prefer):
a) Where the price is not pre-determined by your business for a given type of service, the price of the service or, if an exact price cannot be given, the method for calculating the price so that it can be checked by the recipient, or a sufficiently detailed estimate.
b) Information on any other activities carried out by you or your business, which are directly linked to the service in question and on the measures taken to avoid conflicts of interest. That information should be included in any information document in which you give a detailed description of your services.
c) Any codes of conduct to which you are subject and the websites from which these codes are available, specifying the language version available.
All the information must be given in a clear and unambiguous manner so that it can be easily understood, taking into account the choice of words and style, as well as factors such as the format and structure. The information must also be given in good time before the contract is concluded or before the service is provided when there is no written contract. This is so that the recipient has enough time to digest the information and change their mind about entering into the contract.
Where does it apply?
EU regulations apply not only in the member states, but also in countries that are part of the wider European Economic Area. Countries applying for membership are expected to make laws so that they comply with as many EU regulations as possible prior to becoming members.
Membership of the EU is growing. As of early 2010, these countries are full members-Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and United Kingdom.
There are three official candidates for membership: Croatia, Macedonia and Turkey. There are four other applications in progress: Albania, Iceland, Montenegro and Serbia. Two other applications are under discussion: Bosnia and Kosovo. Switzerland and Norway have been candidates but preferred not to join, but could quickly do so in the future if local opinion changes.
The regulations also apply to non-EU states that are members of the European Economic Area: Iceland, Liechtenstein and Norway.
My company is not based in Europe…….so why should I care?
If you are doing business with any agency or services provider based in Europe, and particularly if they are dealing with customers in your name, then you should ensure that your agents are complying with EU law. It is worth pointing out that the rules apply to businesses in the EEA area, even if their business is,for example, sending patients to Asia.
The rules apply to any business in Europe, and it does not matter where you are based. So if you have a contact office or subsidiary in Europe, but are based in Asia or America-it still applies to you, even if the local office refers people to a website not based in Europe.
It is highly unlikely, but not impossible, that the regulations apply to businesses totally based outside Europe, but targeting European consumers. The logic is to protect EU consumers so there is nothing to stop judges ruling in any individual case that the regulations apply to overseas businesses targeting EU consumers
Should you take notice if you are a healthcare provider or agency outside Europe?
Yes. Although the directive may have no legal impact on your business, if you think it through, what the regulators want is only what most self-respecting consumer friendly businesses will want to do anyway.