Companies in the health and science sector face constant challenges and are now subject to multiple constraints. These include cost and pricing pressures, counterfeit drugs and the tightening of regulatory requirements from European and international authorities.
As new regulations take place day by day, the legal environment you have to deal with is also changing. Added to this are increasing pressures from European and international restrictions and more and more control from public institutions and health regulators. The medical and pharmaceutical fields have also made significant progress, and companies in this industry have become more competitive.
In a context of increasingly fierce competition, the challenge for your company is to remain innovative. Consequently, you must adapt to, and even anticipate, these developments, which raise increasingly complex issues that require the advice of legal professionals.
Our specialist lawyers, operating in a variety of jurisdictions, are aware of the scientific, commercial and legal obligations of your health and life sciences activities. Our multi-disciplinary approach gives us unparalleled expertise in regulatory matters and enables us to assist you nationally and internationally in both advice and litigation.
Our team is used to working with companies active in the health and life sciences industry in sectors such as human and animal health, pharmaceuticals, medical equipment, medical devices, cosmetics, biotechnology and agribusiness.
Our Life Science and Health Law Department is supported by a team of nearly 150 lawyers who are experts in Life Science and are available in all the languages and jurisdictions you may need.
Our experience in these different fields allows us to design the legal framework adapted to the life sciences and health sectors and to advise companies active in these fields as well as their partners.
We are competent to provide you with advice on topics related to life sciences and health such as ;
Marketing and distribution of drugs
Delivery of medication (prescription and non-prescription)
Advertising and promotion of medicines
Sales and design of medical devices
Protection of personal health data and trade secrets
Digital health (e-health)
We are also competent to advise you in strategic agreements (joint ventures), mergers and acquisitions (M&A), asset disposals, private equity or medical litigation such as product liability.
Our team specialising in health and life sciences law offers pragmatic and operational services for all stages of your company’s development. From the start-up stage to the international development of your business or the sale of your activities, the inital public offering (IPO) or the takeover bid.
Whether you are an investor, an IP provider, a founder or a company, we are able to advise all those involved in the life sciences and healthcare fields.
We work with health actors such as :
1. Medical device manufacturers (MedTech):
We provide legal advice on the development, public marketing and promotion of medical devices. The marketing must be accompanied by the respect of numerous European regulations to guarantee the reliability of the product and the safety of the patient in a compliance approach. Our team will guide you to limit the risks of non-compliance.
2. Manufacturers of laboratory apparatus and equipment (LabTech):
LabTech manufacturers are also subject to national and European standards. We can guide you through the development and marketing stages of your projects to ensure compliance with legislation and limit financial and legal risks.
3. Entrepreneurs, Start-ups and SMEs:
We provide legal advice in the research and development (R&D) phase of drugs or cosmetic products and in the launch of your products on the market.
Whether you are a public hospital or a private clinic, we provide advice on various aspects of health and life sciences law: medical liability, development and use of health software or technologies, drafting and analysis of contracts or compliance with the GDPR for the processing of personal data of your clients.
5. Pharmaceutical companies
6. Medical research centres
7. Retirement homes
Our team in the science and health department can assist pharmaceutical, biotech and biochemical companies in their creation and fund raising. We can assist you in choosing the legal form best suited to your needs.
With our lawyers specializing in all areas of law, we pay particular attention to the aspects of intellectual property law and tax law in order to enforce your copyright income.
As far as the development of your products is concerned, our expertise allows us to accompany you at all levels:
• Ensure the confidentiality of your designs by registering patents and licences
• Overseeing research and development and technology transfer from the public to the private sector
• Oversee the setting of prices and reimbursement terms
• Manage your relationships with government agencies, regulatory authorities and healthcare professionals.
With the help of the compliance department, our team of health and life sciences lawyers will assist you in the compliance and regulation of your products. This includes:
• Protection and development of your intangible assets
• Belgian and European marketing authorizations for products in various sectors such as ;
◦ The pharmaceutical industry
◦ Biotechnology industry
◦ The agri-food industry
◦ The biochemical industry
◦ The cosmetics industry
• Obtaining European certifications and CE marking
• Clinical trials
• Health risk management, namely:
• Research and development grants
• The development and negotiation of contracts such as ;
◦ Manufacturing contracts
◦ Sales contracts
◦ General Terms and Conditions of Sale (GTCS)
• Protection and enhancement of medical data (in accordance with the GDPR)
• Marketing your products:
◦ Distribution contracts as well as the registration and traceability of your products
• Product liability
• Registration of trademarks and patents
Finally, our team will assist you during inspections carried out by the health authorities and we will defend you in the event of administrative or legal disputes. We are competent to represent you in both European and national proceedings.
If you wish to benefit from a high level of expertise in the field of health and life sciences law with the help of lawyers adapted to your problems and capable of transforming your legal and regulatory constraints into a competitive advantage, do not hesitate to contact us. We can be reached by e-mail or on our website GOlegal and will contact you within 24 hours.