On April 18th we celebrate European Patients’ Rights Day. In 2002 we were a part of these negotitaitos and efforts to implementing the rights into the charter.
Despite their differences, national health systems in European Union countries place the same rights of patients, consumers, users, family members, weak populations, and ordinary people at risk. Despite solemn declarations on the “European Social Model” (the right to universal access to health care), several constraints call the reality of this right into question. As European citizens, we do not accept that rights can be affirmed in theory but then denied in practice, because of financial limits. Financial constraints, however, justified, cannot legitimize denying or compromising patients’ rights. We do not accept that these rights can be established by law, but then left not respected, asserted in electoral programs, but then forgotten after the arrival of a new government. The Nice Charter of Fundamental Rights will soon be part of the new European constitution. It is the basis of the declaration of the fourteen concrete patients’ rights currently at risk: the right to preventive measures, access, information, consent, free choice, privacy and confidentiality, respect of patients’ time, observance of quality standards, safety, innovation, avoidance of unnecessary suffering and pain and personalized treatment, and the right to complain and to receive compensation. These rights are also linked to several international declarations and recommendations, issued by both the WHO and the Council of Europe. They regard organizational standards and technical parameters, as well as professional patterns and behaviour. Each of the national health systems of the EU countries manifests quite different realities with respect to patients’ rights. Some systems may have patients’ rights charters, specific laws, administrative regulations, charters of services, bodies such as ombudspersons, procedures like alternative dispute resolution, etc. Others may have none of these. In any case, the present Charter can reinforce the degree of protection of patients/citizens’ rights in the different national contexts, and can be a tool for the harmonisation of national health systems that favours citizens’ and patients’ rights. This is of the utmost importance, especially because of the freedom of movement within the EU and the enlargement process.
1-Right to Preventive Measures
Every individual has the right to a proper service in order to prevent illness. The health services have the duty to pursue this end by raising people’s awareness, guaranteeing health procedures at regular intervals free of charge for various groups of the population at risk, and making the results of scientific research and technological innovation available to all.
2-Right of Access
Every individual has the right of access to the health services that his or her health needs require. The health services must guarantee equal access to everyone, without discriminating on the basis of financial resources, place of residence, kind of illness or time of access to services. An individual requiring treatment, but unable to sustain the costs, has the right to be served free of charge. Each individual has the right to adequate services, independently of whether he or she has been admitted to a small or large hospital or clinic. Each individual, even without a required residence permit, has the right to urgent or essential outpatient and inpatient care. An individual suffering from a rare disease has the same right to the necessary treatments and medication as someone with a more common disease.
3-Right to Information
Every individual has the right to access to all kind of information regarding their state of health, the health services and how to use them, and all that scientific research and technological innovation makes available. Health care services, providers and professionals have to provide patient-tailored information, particularly taking into account the religious, ethnic or linguistic specificities of the patient. The health services have the duty to make all information easily accessible, removing bureaucratic obstacles, educating health care providers, preparing and distributing informational materials. A patient has the right of direct access to his or her clinical file and medical records, to photocopy them, to ask questions about their contents and to obtain the correction of any errors they might contain. A hospital patient has the right to information which is continuous and thorough; this might be guaranteed by a “tutor”. Every individual has the right of direct access to information on scientific research, pharmaceutical care and technological innovations. This information can come from either public or private sources, provided that it meets the criteria of accuracy, reliability and transparency.
4-Right to Consent
Every individual has the right of access to all information that might enable him or her to actively participate in the decisions regarding his or her health; this information is a prerequisite for any procedure and treatment, including the participation in scientific research. Health care providers and professionals must give the patient all information relative to a treatment or an operation to be undergone, including the associated risks and discomforts, side-effects and alternatives. This information must be given with enough advance time (at least 24 hours notice) to enable the patient to actively participate in the therapeutic choices regarding his or her state of health. Health care providers and professionals must use a language known to the patient and communicate in a way that is comprehensible to persons without a technical background. In all circumstances which provide for a legal representative to give the informed consent, the patient, whether a minor or an adult unable to understand or to will, must still be as involved as possible in the decisions regarding him or her. The informed consent of a patient must be procured on this basis. A patient has the right to refuse a treatment or a medical intervention and to change his or her mind during the treatment, refusing its continuation. A patient has the right to refuse information about his or her health status.
5-Right to Free Choice
Each individual has the right to freely choose from among different treatment procedures and providers on the basis of adequate information. The patient has the right to decide which diagnostic exams and therapies to undergo, and which primary care doctor, specialist or hospital to use. The health services have the duty to guarantee this right, providing patients with information on the various centres and doctors able to provide a certain treatment, and on the results of their activity. They must remove any kind of obstacle limiting exercise of this right. A patient who does not have trust in his or her doctor has the right to designate another one.
6-Right to Privacy and Confidentiality Every individual has the right to the confidentiality of personal information, including information regarding his or her state of health and potential diagnostic or therapeutic procedures, as well as the protection of his or her privacy during the performance of diagnostic exams, specialist visits, and medical/surgical treatments in general. All the data and information relative to an individual’s state of health, and to the medical/surgical treatments to which he or she is subjected, must be considered private, and as such, adequately protected. 6 Personal privacy must be respected, even in the course of medical/surgical treatments (diagnostic exams, specialist visits, medications, etc.), which must take place in an appropriate environment and in the presence of only those who absolutely need to be there (unless the patient has explicitly given consent or made a request).
7-Right to Respect of Patients’ Time
Each individual has the right to receive necessary treatment within a swift and predetermined period of time. This right applies at each phase of the treatment. The health services have the duty to fix waiting times within which certain services must be provided, on the basis of specific standards and depending on the degree of urgency of the case. The health services must guarantee each individual access to services, ensuring immediate sign-up in the case of waiting lists. Every individual that so requests has the right to consult the waiting lists, within the bounds of respect for privacy norms. Whenever the health services are unable to provide services within the predetermined maximum times, the possibility to seek alternative services of comparable quality must be guaranteed, and any costs borne by the patient must be reimbursed within a reasonable time. Doctors must devote adequate time to their patients, including the time dedicated to providing information.
8-Right to the Observance of Quality Standards
Each individual has the right of access to high quality health services on the basis of the specification and observance of precise standards. The right to quality health services requires that health care institutions and professionals provide satisfactory levels of technical performance, comfort and human relations. This implies the specification, and the observance, of precise quality standards, fixed by means of a public and consultative procedure and periodically reviewed and assessed.
9-Right to Safety
Each individual has the right to be free from harm caused by the poor functioning of health services, medical malpractice and errors, and the right of access to health services and treatments that meet high safety standards. To guarantee this right, hospitals and health services must continuously monitor risk factors and ensure that electronic medical devices are properly maintained and operators are properly trained. All health professionals must be fully responsible for the safety of all phases and elements of a medical treatment. Medical doctors must be able to prevent the risk of errors by monitoring precedents and receiving continuous training. Health care staff that report existing risks to their superiors and/or peers must be protected from possible adverse consequences.
10-Right to Innovation
Each individual has the right of access to innovative procedures, including diagnostic procedures, according to international standards and independently of economic or financial considerations. The health services have the duty to promote and sustain research in the biomedical field, paying particular attention to rare diseases. Research results must be adequately disseminated.
11-Right to Avoid Unnecessary Suffering and Pain
Each individual has the right to avoid as much suffering and pain as possible, in each phase of his or her illness. The health services must commit themselves to taking all measures useful to this end, like providing palliative treatments and simplifying patients’ access to them.
12-Right to Personalized Treatment
Each individual has the right to diagnostic or therapeutic programmes tailored as much as possible to his or her personal needs. The health services must guarantee, to this end, flexible programmes, oriented as much as possible to the individual, making sure that the criteria of economic sustainability does not prevail over the right to health care.
13-Right to Complain
Each individual has the right to complain whenever he or she has suffered a harm and the right to receive a response or other feedback. The health services ought to guarantee the exercise of this right, providing (with the help of third parties) patients with information about their rights, enabling them to recognise violations and to formalise their complaint. A complaint must be followed up by an exhaustive written response by the health service authorities within a fixed period of time. The complaints must be made through standard procedures and facilitated by independent bodies and/or citizens’ organizations and cannot prejudice the patients’ right to take legal action or pursue alternative dispute resolution.
14-Right to Compensation
Each individual has the right to receive sufficient compensation within a reasonably short time whenever he or she has suffered physical or moral and psychological harm caused by a health service treatment. The health services must guarantee compensation, whatever the gravity of the harm and its cause (from an excessive wait to a case of malpractice), even when the ultimate responsibility cannot be absolutely determined.