The practice area of Life Sciences and health lawyers is defined in the widest sense in order to identify those firms capable of providing a full service to industry clients in all life sciences and health-related fields. As such, the practice area encompasses all manner of professional regulation in healthcare and related fields; joint ventures and syndications; taxation; federal and provincial regulatory applications; project, structured, debt, capital markets, private placement and secured financings; intellectual property; privacy; antitrust and competition; sales, marketing, and advertising; outsourcing and service agreements; research and development; supply and distribution agreements; acquisitions, mergers, and takeovers; litigation, including patent infringement and impeachment; product liability; corporate governance; mediation and arbitration; administrative law; employment and labour law.
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A life sciences lawyer, sometimes referred to as a health lawyer or pharma lawyer, or even a biotech lawyer, generally works in relation to the regulation in patenting of pharmaceutical and biotech problems created by their client’s.
Their legal practise entails not only transactional processes but also alternative dispute resolution methods, and court litigations. A life sciences & health lawyer’s work is also cross-disciplinary, as it relates to other areas of law, such as taxation, corporate law, and labour law.
The work of a life sciences & health lawyer, to a large extent, revolves around the registration and licensing of companies they represent – pharmaceutical, biotechnology, drug, or R&D companies – including its new products or substances it may manufacture. When a new company is established, or even during its lifetime, regulations must still be followed, such as those mentioned in the F&DA and its regulations.
Similarly, when a new product has been produced, it must be licensed before it can be commercially distributed for public consumption. Also, in the conduct of R&D and its clinical trials, PDD regulations must be maintained. Hence, a life sciences & health lawyer helps in monitoring compliance of these regulations, especially when federal regulations are made more complex by provincial and territorial regulations.
When new biotechnology-derived products are discovered or manufactured by these pharmaceutical or biotechnology companies, a life sciences lawyer is at the forefront in registering its patent rights under the Patent Act of Canada before the Canadian Intellectual Property Office (CIPO). This is to protect these companies on their new inventions for its exclusive use on the exclusion of all others. In turn, when the IP rights of these companies are infringed, a life sciences & health lawyer proceeds against these violators before the Federal Court, or the superior courts of the provinces.
A life sciences & health lawyer or a life sciences lawyer may also transcend with corporate and finance law, when representing their clients in mergers, acquisitions, takeovers, and other contractual and financial agreements. When international trade or entities are involved, a life sciences lawyer may also have to apply public international law, or private international law when domestic conflicts with an international element arise.
Canadian pharmaceutical industry can be said to be made up of different stakeholders – the private corporations, in relation to the regulating government agencies, and the general public’s health concerns such as safety and reliability on such products. Private companies, which are mainly engaged in the manufacturing of medicines and other drug products, are composed of the different brand-name and generic companies, small and medium biopharmaceutical companies, and those which conducts research and development (R&D).
In regulating these pharmaceutical companies, the Pharmaceutical Drugs Directorate (PDD) implements the regulations set in the Food and Drug Regulations under the Food and Drugs Act (F&DA) at the federal level. The PDD, and the enforcement of F&DA and its regulations are under the portfolio of Health Canada, which is the federal authority on the R&D and production of health products, pharmaceuticals, and biopharmaceuticals.
Formerly the Therapeutic Products Directorate (TPD), the PDD is the agency whose main mandate is to examine the safety, efficacy, and quality requirements of medicines and other drug products before authorising its sale in the Canadian market. Aside from this, the agency is also tasked to evaluate the said drugs’ potential benefits and risks, among other procedures to ensure that it has been studied well through its clinical trials, monitored when there are adverse effects, and informing the public of necessary science-based medical information.
The Food and Drugs Act (F&DA) is the federal law regulating the production, importation, exportation, transportation, and selling of these products:
Accordingly, each product has its own set of Regulations, namely – the Food and Drug Regulations; the Cosmetic Regulations; the Medical Devices Regulations; and the Natural Health Products Regulations.
These products are classified by their respective definitions and criteria set in Section 2 of the F&DA upon application of the manufacturing or pharmaceutical companies. Common among the criteria for classification of either a product falls upon food, drugs, cosmetics, or therapeutic devices are its medical claims and representations; its purpose and intended use in fulfilling its claims and representations; its composition, ingredients or structure; and its format (prepackaged, ready-to-consume, or capsule- or tablet-form).
Applying the principles of a safe R&D space, biotechnology is focused on developing biotechnology-derived products, using novel or alternative methods of producing traditional products. As such, biotechnology is not only applicable in the life sciences sector (such as genetically modified foods, and therapeutic agents), but also in the agricultural (agricultural inputs, livestock products, pest control products), energy (bioenergy and biofuels), and environmental sector. It is also applied to consumer products, such as cosmetics, plastics, and cleaners.
The biotechnology industry has long been recognised by the Canadian government through various initiatives, policies, and other support programs. Thus, regulation of the industry has also been a priority of the federal government, to protect the health and safety of Canadians, while pursuing developments in biotechnology.
Policies and regulations imposed on the biotech industry is a shared responsibility of Health Canada, through the Canadian Food Inspection Agency; Environment Canada; and Fisheries and Oceans Canada.
Specifically, these agencies regulate the research, development, and production of biotechnology-derived products, such as genetically modified and other novel foods, biologics and genetic therapies and assisted human reproduction technologies.
The Canadian Environmental Protection Act, 1999 (CEPA 1999) is implemented by both Health Canada and Environment Canada when it comes to regulating new biotechnology-derived products to ensure the safety of the health and environment of Canadians.
The CEPA 1999, which may also cover the pharmaceutical products governed by the F&DA, mandates the regulation of new biotechnology substances, and toxic substances before and after any of these substances or products are registered, licensed, or released commercially.
First, this is done through risk pre-assessments of the substances’ potential health risks and environmental impacts before its manufacturing, or importation. If results perceive that the new biotechnology-derived product may pose such risks, Health Canada would take preventive action by imposing controls on the manufacture, import, use, release, and/or disposal of the product. The most drastic measure is that the said substance or product may be banned.
Second, after its release to the public or during the post-market stage, Health Canada is also empowered to monitor and track these biotechnology-derived product, or even its by-products.
Interested to know more about the field of life sciences law and its governmental regulations? Consult with a Lexpert Ranked life sciences & health lawyer below.