Seeking Novel Treatments Abroad. Stem Cell Tourism: Risks, Legal Issues and Mitigation – Proceeding of the STEMSO Conference

CellR4 2014; 2 (1): e700

  Topic: Uncategorized     Category:

Abstract

Cross-border travel by patients seeking medical treatment has increased significantly in the past decade. Increasingly, medical tourists are seeking access to treatments that are not yet fully recognized as safe and effective in a patient’s home country, such as certain types of stem cell treatments. However, stem cell tourism poses potential risks and legal issues. This article addresses those issues and provides mitigation strategies for healthcare providers to allow patients access to desired treatments while limiting risks and exposure to liability.

Introduction

Medical tourism, in which a patient travels to another jurisdiction to obtain healthcare services, often assisted by a home-based referring physician and a medical travel facilitator (“MTF”), has grown in popularity over the past several yearsé 1. Although the estimates vary, the market is set to continue to grow at a rate of 15-25% yearly 2. In 2013 alone, it’s estimated that 900,000 Americans traveled abroad for medical treatments 3. There are numerous reasons patients travel outside of their home state or country to seek treatment. Often the costs associated with a specific treatment are significantly reduced by traveling abroad.

Another reason, and the focus of this article, is to gain access to a desired treatment that is simply not available in the patient’s home state or country. These often include novel and sometimes risky procedures that may not be widely utilized or approved. The advent of medical tourism has made it possible to seek out these treatments because, it often happens, that even if the desired treatment is not available in a patient’s home country, it is available somewhere in the world. A prime example is stem cell therapy. Traveling abroad for stem cell treatments, “stem cell tourism,” poses potential significant risks and legal issues. This article addresses the concept of stem cell tourism, the risks and legal issues associated with it, and ways to reduce exposure to liability.

Background

Access to Stem Cell Therapies

Stem cell tourism is travel to acquire cell-therapy related healthcare. According to a Transparency Market Research Report, the global stem cell market is projected to reach US$120 billion by 2018. Stem cell therapies remain unapproved, with few exceptions, in most countries around the world, including the United States. Although touted to be potential treatments for multiple conditions including heart damage and multiple sclerosis, actual results are still uncertain. To date, there are very few stem cells therapies that have proven successful. Those include treatments for blood and immune disorders 4. Advertisements for therapies on the web make stem cell therapies appear endless, although most therapies are still in their infancy, enticing people to try these treatments for conditions that may have little or no alternatives. For those seeking access to such innovative treatments, medical tourism has made this a real option.

The availability of stem cell therapies is more limited than traditional forms of medical treatment for several reasons. In many countries, like the United States, stem cell treatments have been marred by political controversy over the use of embryonic stem cells to treat patients. This has slowed development of stem cell therapies using adult stem cells as well. It is also extremely expensive to conduct stem cell clinical trials and many countries’ regulatory frameworks require demonstrations of efficacy and safety through well controlled trials before approval of a new therapy. By traveling to a location with more permissive regulations regarding stem cell treatments, a patient can avail themselves of treatments that may not have been previously available to them.

Over the past decade hundreds of thousands of people have engaged in medical tourism. Of that number, many have utilized stem cell therapies 5. According to MyMedHoliday.com, one of many medical tourism informational websites, the most popular destinations for stem cell therapies include China, Singapore, Malaysia, Japan and Thailand 6. These countries specialize in many stem cell treatments including for age related diseases and cancer.

Discussion

Risks Associated with Stem Cell Tourism

There are numerous risks associated with stem cell tourism for patients, MTFs, referring physicians and treating providers. One of the most prominent issues for patients is a lack of understanding of stem cell therapies offered as part of a clinical trial as opposed to fraudulent stem cell therapy practices 7. Although there are many reputable stem cell therapy clinics conducting treatments within the bounds of the law, over the past several years, numerous stem cell clinics have been shut down for making fraudulent claims of no risk and raising safety concerns 8. Although many countries do have stem cell therapy regulations, not every medical practitioner claiming to perform these therapies is legally permitted to do so. Even with legal or regulatory permission, stem cell therapies available abroad may still be in their infancy, including the clinical trial phase. Patients should understand that stem cell treatments available abroad may not be a treatment in the traditional sense, but may be through a clinical trial or another experimental form of treatment.

Additionally, medical risks for patients include uncertain side effects, medical complications, infection, tumor formation, unpredicted outcomes, lack of continuity of care and post-treatment monitoring, and lack of cross-border coordination of care.

Often with a bad outcome in violation of a recognized standard of care, there is a legal remedy for a patient. However, stem cell tourism can complicate legal remedies for patients. Importantly, because stem cell therapies are novel, there may not be a fully recognized standard of care for treatment, or a well-established accreditation body, like the Joint Commission International, for stem cell clinics. Depending on the particular jurisdiction, legal remedies may be limited which a patient may not be aware of until seeking a remedy. The jurisdiction in which the patient received treatment and experienced a bad outcome, many not have a recognized legal remedy for that particular situation. Additionally, may countries with favorable stem cell treatment regulations may actually lack a government watchdog overseeing such treatments.

More generally, cross-border medical treatments can result in negative outcomes leading to complex cross-border issues in resolving disputes. Many jurisdictions may have advanced sciences, but they may also have underdeveloped legal systems making dispute litigation cumbersome. Jurisdictional issues could arise over proper venue to hear a dispute and applicable laws governing the dispute. Procedural issues may also arise. International service of process is expensive and can be ineffective. Additionally, it is usually difficult for a domestic-based court to obtaining personal jurisdiction over a foreign treating physician. If and when jurisdiction is established and a dispute is litigated, there are uncertainties regarding damages as well. The inability of a domestic body to enforce an injunction or damages award in a foreign country may leave a patient and other parties to a lawsuit without an actual remedy.

Likewise, for the person or group facilitating the medical travel and the physicians referring the patients, there are risks. Although bad outcomes are always a risk, for treatments as new as stem cell therapies there are more opportunities to impute liability to the individuals and organization linking patients with certain treatment facilities. Facilitators can fall victim to various forms of negligence claims, as well as claims for breach of contract and lack of informed consent if the facilitator does not make the patient fully aware of the risks associated with the particular treatment. They may also be subject to enforcement by government bodies like the Federal Trade Commission (the “FTC”) for truth in advertising, based on what the patient was told by the entity or information contained in its advertising 9. The referring physician may also be subject to negligent referral claims and liability under the theory of agency. Both the MTF and the referring physician are vulnerable to legal claims simply because there may be no other adequate defendant based on the aforementioned challenges in litigating cross-border disputes.

The risks for the treating provider are also numerous. Physicians face malpractice liability for treatment errors. The potential for a malpractice claim is higher when treating medical tourists because the foreign treating physician may have more limited access to the patient’s medical history than a typical treating physician. Because of the experimental nature of stem cell therapies, there is additional malpractice risk. Providers are subject to certain standards of care, although they may not be fully realized in the stem cell therapy context, and falling below those standards can be grounds for imposing liability. Like MTFs, treating physicians can be subject to vicarious liability and corporate negligence claims as well. In certain circumstances, providers can lose their licenses to practice medicine, and if practicing or seeking approval in the United States, may be subject to Food and Drug Administration (the “FDA”) and FTC enforcement 10.

Although the risks associated with stem cell tourism tend to be high, there are ways to mitigate those risks to allow patients to access desired treatments they may not otherwise have the opportunity to receive.

Results

Mitigating Risks When Engaging in Stem Cell Tourism

For all parties involved, patients, MTFs, referring physicians, and treating physicians, the risks and exposure to liability can be mitigated. The two most effective ways to mitigate risks and limit liability are through informed consents and strategic contracting.

Informed Consent

Informed consent makes the patient aware of the risks and benefits for a particular course of treatment. It explains the diagnosis, nature, and purpose of the proposed treatment and explains potential adverse outcomes. These risks should include risks associated with traveling before and after treatment, any potential side effects of the actual treatment, and the treating physician’s expertise in the procedure to be performed. The consent should also inform the patient of additional risks associated with stem cell therapies, as well as provide alternative treatments that the patient could seek. It should also disclose the experimental nature of the treatment, as many stem cell therapies fall within a clinical trial or pre-approval phase. If the patient will be engaging in a stem cell clinical trial, there are additional requirements that informed consents must meet. Specific inclusion guidelines may vary based on the regulatory body overseeing the trial. Full disclosure of the benefits, risks, and experimental nature a stem cell procedure can help ensure that a patient is fully informed and help prevent liability to MTFs, referring physicians, and treating physicians for failing to obtain informed consent. Each jurisdiction has a different definition of what constitutes informed consent so MTFs, referring physicians, and treating physicians should be aware that informed consent thresholds may vary from jurisdiction to jurisdiction. Additionally, as language barriers often arise in the context of medical tourism, informed consents should be properly translated and explained in a way that ensures the highest degree of understanding by the patient.

Strategic Contracting

Contracts between parties can also be drafted to mitigate risks. For example, including contract provisions clarifying payment terms, indemnification obligations, disclaimers of liability, allocation of liability, dispute resolution mechanisms and available remedies before the patient seeks treatment can help not only manage client expectations, but establish steps a party should take in the event a dispute arises. Contract provisions requiring specific physician licensure, credentialing, and treatment facility accreditation and licensure are also advantageous to ensure all necessary medical standards are met. Contracts can also set the jurisdiction, venue, and applicable law under which disputes will be resolved and can provide alternatives to costly and onerous cross-border litigation, in the form of alternative dispute resolution (“ADR”). ADR is a growing substitute for litigation in the medical tourism industry. A contract provision requiring that parties seek resolution before a neutral mediator or arbitrator in a contract can allow for more flexible, cost-effective resolution process, so in the event of a dispute, the parties know in advance their path to remedy.

Other Mitigation Strategies

There are several other risk mitigation tips to consider in the context of cross-border stem cell tourism. Patients can protect themselves through the purchase of medical malpractice insurance for medical procedures. In advance, patients should determine what procedures and outcomes are covered, and if coverage applies to the jurisdiction in which the patient is seeking treatment. The Centers for Disease Control, the American Medical Association, and the International Society for Stem Cell Research have published educational materials to help inform patients and other parties engaged in medical tourism of the risks and ways to avoid them 11 , 12. The American Medical Association’s “Guidelines on Medical Tourism,” which lay out important considerations when participating in medical tourism, are a helpful tool for parties 13. MTFs and referring physicians can consider utilizing liability waivers, which can include disclaimers about endorsing, recommending, or approving healthcare providers. Treating physicians, although it may not be fully developed, can look to bodies like the International Cellular Medicine Society, which have established “Best Practices for Cell Based Medicine” and appear to have an international accreditation framework for stem cell clinics 14. The International Society for Stem Cell Research has also published adherence guidelines for conducting stem cell research 15. Not to be overshadowed by the written mitigation strategies, is the focus on communication between parties. Before, during, and after treatment the referring and treating physicians, as well as the patient should remain connected to ensure a continuum of care that reduces known complications.

Conclusions

The Future of Stem Cell Tourism

As stem cell therapies gain in popularity and credibility, the number of stem cell tourists is bound to grow. The industry is lucrative and can give patients access to treatments that may not have been previously available. Although there are risks and legal issues associated with engaging in stem cell tourism, there are ways to mitigate those risks to allow patients and providers to benefit from stem cell treatments. Proceeding cautiously by using the aforementioned mitigation tips and consulting with appropriate legal counsel can help ensure a safe and sound stem cell tourism experience.

References

  1. See Centers for Disease Control, Medical Tourism Overview, http://wwwnc.cdc.gov/travel/yellowbook/2014/chapter-2-the-pre-travel-consultation/medical-tourism  (back)
  2. See Patients Beyond Borders, Medical Tourism Statistics & Facts, http://www.patientsbeyondborders.com/medical-tourism-statistics-facts  (back)
  3. See Patients Beyond Borders, Medical Tourism Statistics & Facts, http://www.patientsbeyondborders.com/medical-tourism-statistics-facts  (back)
  4. See ISCT White Paper, Cell therapy medical tourism: Time for action (2010), Cytotherapy 12: 965-968, available at http://c.ymcdn.com/sites/www.celltherapysociety.org/resource/resmgr/uploads/files/Resources/Regulatory/CT_Medical_Tourism_ISCT_WP.pdf  (back)
  5. See Centers for Disease Control, supra note 1  (back)
  6. See Centers for Disease Control, supra note 1  (back)
  7. See ISCT White Paper, supra note5 at 966  (back)
  8. See Patient Handbook, supra note 4 at 6  (back)
  9. See U.S. Federal Trade Commission, Truth in Advertising, http://www.ftc.gov/news-events/media-resources/truth-advertising  (back)
  10. See U.S. Food and Drug Administration, FDA Warns About Stem Cell Claims (Jan. 6, 2012), http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm286155.htm  (back)
  11. See Centers for Disease Control, supra note 1  (back)
  12. See Patient Handbook, supra note 4  (back)
  13. See The American Medical Association, New AMA Guidelines on Medical Tourism (2008), available at http://www.ama-assn.org/ama1/pub/upload/mm/31/medicaltourism.pdf  (back)
  14. See International Cellular Medicine Society, Draft Best Practices Standards in Cell Based Medicine (2012), available at http://www.cellmedicinesociety.org/icms-guidelines  (back)
  15. See International Society for Stem Cell Research, Guidelines for Clinical Translation of Stem Cells (Dec. 3, 2008), available at http://www.isscr.org/docs/default-source/clin-trans-guidelines/isscrglclinicaltrans.pdf  (back)

To cite this article

Seeking Novel Treatments Abroad. Stem Cell Tourism: Risks, Legal Issues and Mitigation – Proceeding of the STEMSO Conference

CellR4 2014; 2 (1): e700

Publication History

Published online: 04 Feb 2014