My passion, your safety!
The life sciences (broadly understood as medicinal products, medical devices, dietary supplements, cosmetics and functional foods) sector has seen more mergers and acquisitions than most over the last few years. This is true of both share transactions and product portfolio sales. Effecting transactions on this market requires specialised knowledge. Moreover, a number of administrative regulations need to be taken into account (not all the legal solutions permitted in other sectors can be applied to e.g. medicinal products or medical devices). Being aware of these special conditions, and being able to factor them into any legal solutions, opens up a sea of opportunities for businesses operating in or planning to enter this market.
The Law Firm offers the following M&A transaction services:
- Pre-transactional analysis (due diligence);
- Transaction handling (negotiating transactions and drawing up the necessary documents, including instruments to protect the party we act for);
- Post-transactional services (acquiring rights and shares is usually the starting point for the next stage of intensive work. This involves fulfilling the statutory and regulatory requirements of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, the Patent Office of the Republic of Poland, the Chief Pharmaceutical Inspectorate, and the National System for the Registration of Cosmetic Products, and the National Court Register).
The manufacture, sale and distribution of medical devices is a rapidly developing sector of the industry. Streamlined administrative procedures and lower market entry thresholds (relative to those for medicinal products) have increased demand for medical devices. However, uncertainties invariably arise over “borderline” products, i.e. products that may or may not be classified as medicinal. These cases not only require scientific and/or technological analyses, but also an assessment of the legal risks involved.
These issues have now assumed greater significance than ever. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, and Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices come into effect in May 2020. These new EU laws will replace the existing domestic statutes and require all market players to adjust their business operations accordingly. The Law Firm can assist with this process and ensure that your business complies with the new regulations.
The marketing of an innovative medicinal product can take well over a decade and cost hundreds of millions of dollars, and there is no guarantee that this investment will break even, let alone make a profit. Few pharmaceutical companies have the necessary resources to take this risk. So, how do new drugs come on to the market? The vast majority are generic products, i.e. equivalents of established registered drugs. They offer identical therapeutic results, but are considerably cheaper for both manufacturers and patients. These medicines are usually marketed locally under licence. The licence agreement is therefore the fundamental document granting unrestricted manufacturing, marketing and distribution rights. I have been involved in negotiating numerous licence agreements for medicinal products and medical devices. These negotiations were held with licensors from the UK, Germany, Greece, Portugal, Spain, Cyprus, and Italy.
Marketing medicinal products is one of the most heavily regulated areas of the market, but it also enjoys the greatest degree of harmonisation at the EU level. Every stage of marketing a medicinal product requires obtaining the relevant permits, authorisations and approvals from the appropriate regulatory and administrative bodies. Related products, such as medical devices, cosmetics and dietary supplements, while not subject to such stringent requirements, are still governed by specific rules and regulations. Drug reimbursement is another crucial and legally complex marketing issue. My familiarity with the relevant issues and the regulations governing them, along with my longstanding experience, means that I can assist you with the following issues and procedures:
- Obtaining and altering marketing authorisations;
- Changing marketing authorisation holders;
- Obtaining or altering manufacturing and/or import authorisations;
- Obtaining the necessary permits to operate a pharmaceutical warehouse and/or engage in parallel importing;
- Distribution Agreements;
- Advertising and promotional activities;
- Reimbursing medicinal products, medical devices and food products.