MAKING HEALTH LAW WORK FOR YOU
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Elsabé Klinck & Associates is a dynamic health care consulting service, focusing on law, regulation and policy in the health sector. They are committed to overcoming challenges in health care regarding policy and law. Their consultants are intensely aware of how these factors influence health care professionals, pharmaceutical companies, medical device companies and other health care stakeholders.
Health law has been developing at a rapid pace and a number of new laws are proposed annually and envisaged for the foreseeable future. Elsabé Klinck Consulting keeps clients abreast of these developments and create awareness and understanding of the implication of new legislation. They assist with submissions to parliament, or relevant government departments. Such legislation includes the National Health Act and its regulations, the Children’s Act, medicines legislation, health professional regulation, etc.
Since the 2008 Roadmap to Health, there has been a significant shift in health policy. Understanding developments in health policy and consultation is critical in responding to, or effecting change. It also assists investors and gives an understanding of the environment in which new health products or services are launched.
EKA renders a B-BBEE preparatory service for clients up to the point of verification. This process normally starts with a pillar-by-pillar analysis and a report indicating the options available to the business. They assist clients in implementing sustainable practices to maintain and better their scores and provide an interpretation service, should there be uncertainty as to the meaning of B-BBEE provisions.
The Access to Information Act (PAIA) as well as the Protection of Personal Information Act (POPIA) affect all health sector role-players. Policies and practices relating to the collection, storage and use of data and personal information, as well as the circumstances under which information could be accessed by third parties, are governed by these laws. The sale of data and patient registries and patient and doctor databases are also affected. It also affects patient registries, outcome databases and vigilance reports.
This service assists clients in, not only complying with the submission of an annual employment equity (EE Report), but also in complying with some of the important legal criteria found in the Act and regulations. These criteria go beyond the numerical analysis, focusing on workplace transformation. A stronger emphasis by the Department of Labour on Employment Equity compliance is likely to lead to greater scrutiny of employers. New EE Regulations have now changed the way in which employment equity must be implemented.
Although part of human rights, consumer rights are set to change the health service and product provision landscapes tremendously over the coming years. The Consumer Protection Act (CPA) impacts on all forms, contracts, terms and conditions, marketing materials, displays, pricing and invoicing, policies on delivery and return, etc. EKA is capable of doing a complete analysis of all aspects in all types of health sector business (from individual practices to multi-nationals) from a CPA perspective. They also review marketing materials for clients against the CPA.
The funding of health care is a hot topic and many businesses find themselves at the receiving end of debates on this issue. EKA understands how the Medical Schemes Act and its regulations work and keep tabs on rulings of the Appeal Committee at the Council for Medical Schemes (CMS). They assist with complaints to the Council for Medical Schemes. EKA has a solid understanding of social security principles and the implications of various possible forms of national health insurance. With NHI currently on the horizon, they assist role-players in building scenarios as to how it will affect them and keep them up to date on developments in the field. Elsabe’s work for the Taylor Commission on Social Security also enhanced her principled understanding of NHI as a social security mechanism. Recent developments in market access models form an important service to clients.
Public sector health funding impacts not only on service delivery, but also on relationships with suppliers and academic institutions. EKA understands how the current funding mechanisms work and how one could leverage to contribute meaningfully to the public health sector. Issues relating to essential mediaries – including essential equipment lists , as well as state tenders are addressed for clients.
Ethics go beyond informed consent to treatment and the right to confidentiality in the health sector. Codes of Conduct, ethical rules, Codes of Marketing, Business Practice Codes and similar mechanisms have become the norm in the health sector landscape. Due to their experience in the health sector, EKA understands the rationale behind these principles and its interpretation and application to various settings. They are able to assist clients in evaluating conduct, projects and practices against such principles. EKA develops SOP’s for clients on these matters, evaluate materials and projects and provide assistance on code complaints.
As with general health care legislation, laws relating to health care professionals are also changing. EKA is familiar with the Health Professions Act, the Nursing Act, the Pharmacy Act and the regulations and guidelines issued in terms of it. This means they are able to evaluate agreements, business models, and conduct against professional legal frameworks.
For the past couple of years, health care has been mentioned in industrial policy. The conditions for trade locally and policies in favour of export into other countries, have prompted stakeholders to explore new avenues. The export market and local manufacturing has also increased in importance as key government priorities. Competition law is another important shaper of market conditions and its impact on the health sector is a matter of continued debate and practical importance. EKA renders business environment services, as well as competition law assessments.
The King III report has placed renewed emphasis on the duties of Boards of Directors and the need for external and independent monitoring. EKA does legal compliance audits for entities, ensuring that risks that could materialize from non- or partial compliance with legal principles, are anticipated and corrective action taken, where needed. EKA also renders company secretarial services.
Nothing has impacted the health sector more than the Constitution and human rights. Major cases affecting the health sector (such as the pharmacists’ dispensing case, the RPL case and the road accident fund challenges) have been decided on the basis of the Constitution. EKA assists clients in understanding how these constitutional principles “work” in circumstances that affect them.
All interactions between subjects and state institutions, as well as regulatory bodies, such as the Medicines Control Council (MCC), Pricing Committee, Health Professions Council (HPCSA), Council for Medical Schemes (CMS) and others are subject to the principles of administrative justice. Proper processes have to be followed, conduct has to be authorised and reasons given. This field of law is often under-utilised by those who are subject to decisions by such bodies, or not well-known by such bodies.
Occupational Health Law
As part of legislation adopted after 1994, Occupational Health Law has taken on new meaning within a constitutional dispensation. Training and systems development are often needed to ensure compliance. The above services are rendered in formats that suit the needs of our clients, such as: · Memoranda · Power point presentations · Talks to stakeholders’ audiences · Legal opinions · Tools (e.g. checklists, templates, guides) Short summaries · Brochures · Reports · Training / update sessions Â· Monthly client-specific updates or scans