Medical, Health Law and Pharmaceutical Law

Medical law is the body of laws concerning the rights and responsibilities of medical professionals and their patients. Issues such as confidentiality, negligence and malpractice, often giving rise to not only civil but also criminal action, are the focus of this area of law. The medical practitioner owes his patient a duty of care, and a breach of this duty renders the practitioner liable to damages and prosecution. A medical lawyer is a legal professional who is trained not only in the general field of law, who also possesses a profound understanding of medicine and bioethics and the standards involved in medical practice.

The World Health Organisation (WHO) defines health law as ‘the area of law concerned with the health of individuals and populations, the provision of health care and the operation of the health care system.’ In Malta, the Public Health Regulation Department / Superintendence of Public Health is responsible to develop and implement strategies to promote and improve public health; issue standards for public health; licence health care service and diagnostic facilities; regulate health care professions; advise the Minister responsible for Health on matters regarding public health; ensure that the regulatory functions emanating from law are properly discharged and carry out any other function emanating from national legislation. Examples of laws dealing with health law in Malta are the Health Act of 2013, the Public Health Act of 2003, the Mental Health Act of 2013, Health Care Professions Act of 2003, etc…

Pharmaceutical law is the body of law which regulates the manufacture, sale, distribution, and use of pharmaceuticals. These laws include intellectual property rights to protect pharmaceutical manufacturers' research, safety standards to protect the public from harmful side effects, restrictions on advertising and marketing of medicines, and rules regarding such medicinals may be prescribed and distributed. The main legislation related to medicinal products is Directive 2001/83/EC as amended. This Directive was transposed in the Maltese legislation as the Medicines Act (Chapter 458 of the Laws of Malta). The Medicines Authority was established by virtue of the Medicines Act of 2003. The mission of the Medicines Authority is to protect and enhance public health through the regulation of medicinal products and pharmaceutical activities.

Lexvirtualis™ can assist you in the following areas:

Medical Law

• Malpractice cases (advancing or defending a malpractice claim)

• Liability (both civil and criminal) and compensation

• Medicolegal research

• Forensic cases

• Legal advice and assistance to medical professionals (eg. liability, insurance, etc)

Health Law

• Compliance with national and EU laws

• Drafting of laws and regulations (eg. transposition of EU directives)

• Entitlement to healthcare services

• Liability and Compensation

• Bioethics

Pharmaceutical Law

• Regulatory Compliance with EU and national laws and regulations such as product compliance (eg. labelling, packaging, medical packaging leaflet)

• Licenses (importer, wholesaler, distribution, pharmacy)

• Product Liability

• Intellectual Property rights (eg. trademarks)

• Certification relating to manufacture and distribution

• Marketing authorisations of medical products