Perhaps you are in the international healthcare field in some capacity – as a provider, insurer, project developer, a medical tourism facilitator or patient. When it comes to the myriad of laws that may impact a medical tourism patient’s experience in travelling internationally for medical procedures and related services, you may ask, among other questions: What should I know about, and more specifically, what regulatory health care legal issues are relevant to the international/cross border healthcare experience? This article is intended to present, in a general, broad overview, those regulatory subject issues which Turkey-based and other health care consumers might confront or want answers to in planning their medical and health tourism experience.
International medical and health tourism law in Turkey comes into effect when consumers elect to travel across international borders with the intention of receiving some form of medical treatment. This treatment may span the full range of medical services, but most commonly includes dental care, cosmetic surgery, elective surgery, and fertility treatment.
Important legal issues may arise around consumer and privacy protection, malpractice, organ trafficking, cross border affairs, insurance and accreditation of facilities and so on. One of the most important problems to be discussed is the liability arising from the damage that occurs during the treatment process.
Movement of patients across borders
The global growth in the flow of patients and health professionals as well as medical technology, capital funding and regulatory regimes across national borders has given rise to new patterns of consumption and production of healthcare services over recent decades. A significant new element of a growing trade in healthcare has involved the movement of patients across borders in the pursuit of medical treatment and health; a phenomenon commonly termed “medical tourism”.
There has been a shift towards patients from richer, more developed nations travelling to less developed countries to access health services, largely driven by the low-cost treatments available in the latter and helped by cheap flights and internet sources of information.
Emerging global industry
Medical tourism is an emerging global industry, with a range of key stakeholders with commercial interests including brokers, health care providers, insurance provision, website providers and conference and media services.
It is apparent that the range of treatments available in Turkey for prospective medical tourists are wide, including;
- Cosmetic surgery (breast, face, liposuction)
- Dentistry (cosmetic and reconstruction)
- Cardiology/cardiac surgery (by-pass, valve replacement)
- Orthopaedic surgery (hip replacement, resurfacing, knee replacement, joint surgery)
- Bariatric surgery (gastric by-pass, gastric banding)
- Fertility/reproductive system (IVF, gender reassignment)
- Organ, cell and tissue transplantation (organ transplantation; stem cell)
- Eye surgery
- Diagnostics and check-ups.
Turkey is one of the world’s leading Health Tourism destinations. In addition to the available high-quality facilities, medical tourists have access to thermal spas and health care programs that incorporate five-star hotel accommodation into their package. Turkey has been a popular destination for medical tourists from European countries such as Russia, Ukraine, Germany, England, the Netherlands, Romania, Bulgaria, and other countries as well as the Middle East and Latin America.
According to data by the Turkish Ministry of Health;
- In 2002, the share of health expenditures in tourism revenues of Turkey was 1%; however, this rate increased to 4.5% in 2020.
- In 2019, 701,046 patients received health services, within the scope of health tourism and tourist health. The amount of tourism income from foreign visitors and citizens residing abroad visiting for health and medical reasons was 1.492.438.000 USD in 2019.
- In 2020, 407,423 patients preferred Turkey to receive health services as the global epidemic caused a noticeable decrease in the number of health tourists. The amount of tourism income from foreign visitors and citizens residing abroad visiting for health tourism and medical reasons decreased to 1.164.779.000 USD in 2020.
- In 2021, 670,730 people received health services and the amount of income obtained was 1.726.073.000 USD.
- In 2022, 1.258.382 people received health services and the amount of income obtained was 1.926.094.000 USD.
The most preferred clinical branches by international patients are respectively: Gynecology, internal diseases, ophthalmology, medical biochemistry, general surgery, dentistry, orthopedics and traumatology, infectious diseases and otorhinolaryngology.
Important questions remain with regard to how consumers assimilate and synthesise the information they retrieve from website searches, and how they take into account commercial interests and bias when making decisions. We assist individuals to access, process and judge medical tourist information they retrieve given such information may be confusing, overwhelming, and even contradictory.
Quality of information
The range of medical tourism sites and related content raise concerns associated with unregulated on-line health information. The internet sites are relatively cheap to set up and run, and contributors may post information without being subject to clear quality controls or advertising standards. Selective information may be presented, or presented in a vacuum, ignoring for example issues such as post-operative care and support. There is always the possibility of unreliable products being marketed via the internet – poor-quality surgery or inadvisable treatments, unnecessary and even dangerous treatments. The quality of health information online is variable and should be used with caution.
There has been a steady rise in the number of companies and consultancies offering brokerage arrangements for services and providing web-based information for prospective patients about available services and choices, which can be attributed to the transaction costs associated with medical tourism, where individuals have to assemble their own information and negotiate any treatment. Typically, brokers and their web-sites tailor surgical packages to individual requirements: flights, treatment, hotel, and recuperation.
A series of interrelated issues exist around the precise role of these intermediaries in arranging surgery in Turkey: how do they determine their market, source information, choose providers, and subsequently determine what the most appropriate advice is? A number of potential legal issues that arise with regard to brokerage may be identified.
Relatively small clinical providers may include solo practices or dual partnerships, offering a full range of treatments. At the other end of the scale are extremely large medical tourism facilities where clinical specialism is the order of the day. Hospitals may be part of large corporations, and ownership itself may lie primarily in the higher income countries from where patients mostly originate.
Quality, safety and risk
There are a range of organisational dimensions related to the quality and safety of medical treatment in Turkey. As with all medical treatments, an element of risk exists to the patients’ health, which is supposedly outweighed by the potential benefits resulting from the treatment.
Treatment processes (including consideration of quality, safety and risk) and system-level implications for countries of origin and destination (financial issues; equity; and the impact on providers and professionals of medical tourism) are highlighted by our legal team members. Patients should receive appropriate advice and input at all stages of the caring process. Our lawyer examines harm, liability and redress in medical tourism services with a particular focus on the legal, ethical and quality-of-care considerations.
Whilst legal issues arise for all forms of medical care – informed consent, liability and legislating for clinical malpractice – these are intensified for medical tourism. “Cosmetic tourism”, “fertility tourism”, “transplant tourism”, to say nothing of recent developments in the areas of “stem cell‘tourism” and “euthanasia tourism‘, raise ever-more complex medico-legal questions.
What procedure exists, if any, for obtaining the informed consent of the patient? Informed consent is the process whereby the patient is informed of the risks, benefits and treatment alternatives available so as to allow the patient to make an informed decision electing the care and treatment provided.
It is generally the duty of the licensed professionals and facilities as a condition of their licensure to obtain the patient’s informed consent before performing medical treatments and procedures, and whereas the governing rules generally arise from the location where the licensed provider or facility are rendering the services, the informed consent rules and laws of Turkey are likely to control in the case of medical tourism services.
With regard to informed consent generally, it should be understood whether the informed consent, to be effective, must be in written form. Does the patient have an understanding of the actual risks and benefits of a procedure or treatment, and any available alternatives?
Must the informed consent be provided and documented in the language that is the patient’s primary language? Are providers required to have interpreters available to explain the procedures and throughout the medical care experience, as needed?
Given the significant investment of time and money involved by both patients and providers, the informed consent process should be substantially addressed well before funds are invested for travel and procedures are scheduled by the provider, even if the final written consent forms are not presented to the patient until their initial in-country meeting with their surgeon and hospital intake staff.
In Turkey, signed informed consent prior to an elective procedure is considered best practice and a standard requirement ensuring that patients are fully informed as to the benefits and adverse effects of a procedure or treatment they are being advised to undergo, and they also have the opportunity to ask questions and seek answers
Patient Travel Issues
For the medical tourist, it is also important to know what travel documentation laws and requirements apply? What passports or visas are required for the patient and any travelling companion? Are there limits to the patient’s length of stay in Turkey where the medical procedure is being performed?
If so, what impact might such rules have if medical complications prolong the patient’s need to stay in Turkey longer? Is special permission required for extended stays? What actions should the patient take if a travel or visa issue arises related to the length of stay-should the patient or their advocate contact their home embassy, Turkish immigration authority, or both?
What are the options if the patient is unable to leave with medical clearance for travel before their original visa expires, such as when flying is against medical advice?
Licensing and Regulation of Facilities and Professionals
Turkish licensing requirements of professionals and facilities rendering the service may be of interest to the patient considering medical tourism?
Medical tourists, facilitators, and insurers in Turkey and elsewhere have come to ask whether the destination medical facility is accredited?
Where accreditation is present, it helps the travelling patient, their facilitators, family members, local providers, and insurers gain confidence in and choose the medical tourism option, including providing insurance coverage benefits for the patient’s out of country health care services.
A patient travelling for medical procedures should also inquire and understand whether and how patients have the right to designate a surrogate decision-maker if the patient becomes unable to voice his or her care preference at some point in the process.
If such rights exist, a medical tourist and their travelling companion should understand under what circumstances do they arise, and what are the limitations on the extent of authority which is given to a surrogate decision-maker? What forms and procedures are required to establish such a back up decision-maker?
Does Turkey have different rules than the patient’s home country? If so, which laws will control- those of the patient’s home country or the laws of the site of the provider?
Will the patient’s existing documentation be honored, or can the patient and provider contractually agree to honor and permit the surrogate decision-maker to step in if the same conditions exist which would vest authority in the patient’s country should arise, such as during the patient’s loss of capacity (due to heavy anesthesia, unconsciousness, or other condition)?
Payment and Insurance Benefits
Whether or not insurance payment benefits are available is important to all parties when expensive health care procedures and treatment are involved. Will the patient’s health insurance or related benefits apply outside of the patient’s home country borders, as in Turkey currently?
Medical tourists, their providers and insurers should understand how Turkish rules in the patient’s and the provider’s jurisdictions affect payment and claims processing. Can health coverage benefits be assigned to providers to bill insurers directly, or must the patient bear the burden of paying all expenses out of pocket and submitting a claim to his or her insurer for reimbursement?
Providers and patients should know if there are auditing procedures after payment (“post-payment review”) that require timely response, submission of supporting documentation, and which potentially place payments made at risk of recoupment or demand for repayment.
Medical Records Issues
Other practical considerations exist with regard to sharing and providing medical records to the out of country providers in advance of treatment. Are certain portions of the patient’s historical medical record needed in order to authorize and ultimately deliver care and perform procedures (such as diagnostic tests, imaging scans, or history and physical notation of certain diagnostic codes/disease states under the international classification of diseases system)?
What authorizations are required by the providers and the patient’s governing laws as a condition of releasing records to other providers, to insurers-for payment or reimbursement of patient’s charges, and to the patients or their advocates?
What technical mechanisms are present to exchange and share records of the patient’s care, including for proper after care coordination and follow up back in the patient’s home country? How can the out of country medical records become a part of the medical record of the patient and available to their home country providers for access later?
Privacy and confidentiality
How is personal patient data protected? This data can include financial and other very personal and private information above and beyond medical care and conditions. Is there a right to privacy and protection with regard to the use and disclosure of patient information?
What rights are provided to patients under the laws of Turkey? Does each patient have the right to be informed and participate in their care decisions, the right to have advance notice of their payment obligations, the right to have visitors, and a right to access and have complete copies of their own medical records?
The use of IT information by professionals and how patient information flows across national boundaries are further important questions for the regulation of the medical tourism industry.
One may ask whether tourists and visitors have the same rights as citizens of Turkey with regard to the confidentiality of their personal data and information, especially when these are stored in electronic formats.
There may also be issues of confidentiality related to the clients of companies who act as facilitators of medical tourism. The staff of medical tourism facilitators’ offices may be party to clinical information on patients, and this private and sensitive information would need to be dealt with very carefully and there is potential for them to sell the information to other medical service companies.
Common questions raised by medical tourists are;
- What happens if something goes wrong?
- May I seek a refund for the initial surgery, compensation for the cost of a new surgery, and damages for the emotional distress I have suffered?
- Can I sue the provider in the home country or in Turkey?
- What range of optional and mandatory dispute resolution methods are available in Turkey?
- Is there a system of litigation of personal injury claims in Turkey?
- What procedures govern disputes between the patient and any provider of care?
- Do procedures vary with the type of dispute, such as a payment dispute versus a liability claim for a bad result?
- May remedies be limited and governed by agreement in advance?
- Are claims limited to return or forgiveness of fees, or are there rights to recover consequential damages, such as lost earnings?
- Is it possible to recover monetary damages for claims of permanent harm or disfigurement?
- Are there any treaties and conventions between the nations of the participants that limit remedies, direct dispute resolution to certain forums and bodies, or otherwise impact resolution of disputes and the remedies available?
If patients experience poor-quality treatment which results in adverse outcomes and as a result wish to bring a civil or criminal case, our legal team members do not let clients face potential confusion with a number issues not fully clarified.
Our legal team members give advice whether a dissatisfied medical tourist should sue the individual surgeon, the clinical team, the hospital, or even the broker that may have arranged the treatment.
A potential difficulty in pursuing a breach of contract or clinical negligence is that medical tourists may be encouraged to sign legal disclaimers prior to receiving treatment that restrict where any subsequent case will be held, the law that will cover it, and include further liability limitation or exclusion clauses.
Pursuing a legal case in Turkey brings its own difficulties. Should complications arise during medical tourism, patients may not be covered by insurance or indemnity policies that are carried by the hospital, the surgeon or physician treating them, and they may have little recourse to local courts or medical boards.
Travelling to Turkey to pursue a legal case also involves having to employ a suitable lawyer, and problems with regard to arranging travel and accommodation as well as the potential legal, language and cultural difficulties of courtroom understanding.
If a favourable judgement is handed down in Turkish jurisdiction – to what extent is this enforceable or likely to ensure a significant financial award?
Controversial Treatments and Procedures
As if the above legal and regulatory issues material to cross-border health care/medical tourism are not enough, some of the most complex issues can arise when controversial issues are involved, such as use of stem cell therapies, organ transplant, (organ donation, harvest/ and transplantation), fertility and conception-including genetic screening, gene therapy/genetic code splicing, and use of certain pharmaceutical, biological agents, or medical devices which are not approved for use in the medical tourist’s home country.
Often there are fewer rules and prohibitions when it comes to the most cutting edge of therapies, treatments and procedures; and opportunities often exist where the medical community is “out front”.
Although payers often deny payment of innovative or controversial treatments and therapies as being “experimental”, it does not mean that the patient does not have the choice (provided that the patient has the means) to obtain such cutting edge treatments.
As a procedure or treatment moves into and becomes “evidence-based medicine”, it often also becomes a covered service under payment and insurance benefits, and part of the accepted and ever changing landscape of medical care.
Medical tourism has a place at the forefront, given that with the myriad of geographic locations and governments, and cultural and religious diversity around our world, there are always going to be places where a meritorious, innovative treatment or procedure can be obtained by those medical tourists of our time in search of excellence in health care.
Working closely with each client, we provide comprehensive services, offering strategic planning advice, regulatory assistance, and litigation services to meet their specific goals and assure their compliance with all applicable laws.