As the field of research and development progresses at unprecedented levels to provide solutions for humanity’s emerging needs, so does the legal area of life sciences. As such, life sciences lawyers are here to guide institutions on the touchpoints of the fields of law and medicine.
What is the law of life science?
The practice area on life sciences law generally pertains to the regime of laws and regulations governing the activities of the companies or organizations that are engaged in the fields of biotechnology, pharmaceuticals, medical devices, and other medical or health related fields. It also includes laws and regulations that apply to its corporate and internal activities.
There is no single federal law in Canada governing life sciences. The applicable common law and federal or provincial laws for every aspect and activity of life sciences companies would govern.
What does a life sciences lawyer do?
A life sciences lawyer or firm focuses on two main things: first, the life sciences company or corporation itself; and secondly, the products of the life sciences company.
A life sciences lawyer is not only knowledgeable in the law but also in the fields of medicine, biotechnology, and other related areas.
The life sciences lawyer guides companies on the legal considerations in every stage in the life of the corporation – from its set up, financing, and other regulatory compliances as mandated by Canadian law.
Some examples of client-corporations that life sciences lawyers work with are:
- biotech start-ups
- institutions doing research and development (R&D)
- pharmaceutical corporations
- manufacturing and/or distribution companies
- hospitals, pharmacies, and retailers
The life sciences lawyer also assists in a product’s licensing and authorizations – from its R&D and trial stage, to its registration under relevant intellectual property laws, until it is manufactured and produced.
Life sciences lawyers also assist in post-production transactions such as the products’ marketing and advertising according to law.
The legal practice of life sciences lawyers and law firms are both litigious and transactional in nature.
Contracts and Agreements
The bulk of transactional activities of a life sciences lawyer involves contracts. Most of the time, their legal practice revolves around negotiating and preparing contracts and commercial agreements for their client-corporations. This will also involve legal counseling regarding the contracts’ execution, renewal, and repeal whenever necessary.
Here, common law principles on the law on contracts of Canada would govern, or Québec’s Civil Code if the client-corporation is in Québec.
If a client-corporation decides to partner with another institution, their life sciences lawyer can help with:
- technology transfers
- R&D collaborations
- partnerships on licensing
- manufacturing, supply, and/or distribution
There are other industry trends in life sciences, such as convergence with artificial intelligence (AI).
Check out more of this emerging trend by consulting a life sciences lawyer in your province. If you are based in Montréal, contact one of the best life sciences lawyers in Québec as ranked by Lexpert.
Financing and Taxation
Raising capital for these institutions through contracts and agreements is important. Operations in the life sciences industry are costly and would entail huge amounts of resources. Canadian taxation laws and international laws which will apply here, especially for investments coming from different countries.
Mergers and Acquisitions
Two or more corporations may go into a merger and acquisition (M&A) to increase their capital and sharing of technologies. For such contracts or transactions on M&A, a life sciences lawyer works with their client-corporation regarding the legal regulatory regime that would prevail such as the pertinent provisions of Investment Canada Act and the Competition Act.
Find out about the biggest mergers and acquisitions in Canada with this article.
Regulations on Products
Certain Canadian laws and regulations apply to life sciences products such as drug products, pharmaceuticals, and medical devices.
Numerous Canadian laws would typically apply during the manufacture, importation, labelling, distribution, and sale of these products, such as the Canada Consumer Product Safety Act and the Food and Drugs Act (FDA).
Relevant regulations of the FDA would also apply such as the Food and Drug Regulations, the Medical Devices Regulations, and the Natural Health Products Regulations. These laws and regulations are primarily administered by the Department of Health Canada (Health Canada).
These laws and regulations would also govern the following activities or transactions:
- drug establishment licensing
- non-clinical studies
- clinical trials
- “named-patient basis” procedures
- compassionate use procedures
- market authorizations or pre-market clearances
- post-approval obligations
Liaising with Health Canada and other regulatory bodies would also be part of the job of a life sciences lawyer. They would be especially involved when there are objections and disputes before the grant or approval of any necessary licenses and permits.
Advertising and Marketing
Aside from Canadian laws on advertising and marketing, FDA regulations, and the Competition Act, medical field-specific regulations and codes of conduct will also apply to these life sciences companies such as those published by MedTech Canada, the Pharmaceutical Advertising Advisory Board, and the Innovative Medicines Canada.
Compliance with these codes, in addition to other guidelines from Health Canada and the Competition Bureau on advertising and marketing, may be consulted with life sciences lawyers.
Intellectual Property
As new medical products are developed, the companies that created them would typically want these products to be protected as intellectual property (IP). Here, a life sciences lawyer may apply their legal knowledge on licensing and registering IPs under Canadian laws.
For new products, patent registration with the Canadian Intellectual Property Office falls under Canada’s Patent Act and its specific regulations applicable to life sciences, such as:
- Patented Medicines (Notice of Compliance) Regulations
- Patented Medicines Regulations
- Certificate of Supplementary Protection Regulations
Aside from patents, trade secrets are also vital to these companies, especially during the R&D and trial stages. Life sciences lawyers may also assist companies in protecting these trade secrets through contracts and other internal systems.
Litigation
The life sciences lawyer’s expertise in Canada’s legal processes and court rules applies when litigation is an option in resolving disputes. This is without prejudice to alternative dispute resolution methods which may be preferred in settling these disputes.
Causes of action for these litigations may include violations of the contracts that the client-company entered with another institution or cases of intellectual property infringement.
Find out more about the work of life sciences lawyers by consulting with the best life sciences lawyers in Canada as ranked by Lexpert.