Overview
In the field of life sciences and pharmaceuticals, the focus is on delivering positive results for health and well being and targeting the optimal management of illnesses, while at the same time navigating through a wave of new challenges facing life sciences and pharmaceutical companies. In this climate, the need for a team of lawyers who, in addition to an inherent understanding of legal provisions and the current status quo, have the knowledge, experience and capabilities to proactively help clients face the everyday challenges of the industry, is essential.
We are proud of our Life Sciences and Pharmaceutical practice which is at the forefront of developments and is committed to delivering excellence in all its dealings.
Our Relevant Experience
- We have advised many international innovative pharmaceutical companies on strategic issues from a pricing and reimbursement perspective in the context of the multiple changes of the pricing legislation.
- We have advised various international innovative pharmaceutical companies in respect of regulatory issues related to clinical trials, including drafting and revising different types of agreements and the supporting documentation necessary to the performance of the clinical trials.
- We have advised several international pharmaceutical companies in relation to the transparency obligations and disclosure procedure as regulated by local Romanian legislation and by the pharmaceutical industry disclosure codes, including revising all documentation to be submitted to the relevant authorities.
- We have advised and assisted large international pharmaceutical companies in relation to various internal investigations, including forensic activities, revision of information, interviewing employees, drafting investigation reports, assisting with internal standard operation procedures and providing training for employees.
- We have advised and assisted an international company regarding the restructuring of a local hospital.
- We have advised various international medical device manufacturers and distributors in relation to the commercial activity performed in Romania, and the necessary authorisations to be obtained from the relevant authorities.
- We have advised and assisted local and international healthcare professionals with their relationship with public and/or private local hospitals or private clinics.
Key Contacts
Pharmaceuticals
The pharmaceutical industry is responsible for the development, production and marketing of medication and its importance as a global sector is indisputable and cannot be underestimated.
The main aim of the industry is to develop and provide medicines that prevent or cure diseases and help maintain health. As such, it is an industry that directly affects the lives of everyone around the world and has several international regulatory bodies to monitor the safety, quality and pricing of medication, together with patent applications and registrations.
In Romania, medicines are subject to a variety of laws and regulations issued by various authorities including the Romanian Ministry of Health, the National Agency for Medicines and Medical Devices and the National Health Insurance House. These authorities have a role in relation to the patenting, testing and marketing of medicines, especially prescription-only medicines.
While most observers predict a robust expansion of the Romanian pharmaceutical market in comparison with its fellow EU member states, there are caveats to this. Issues over pricing, claw back taxes and the uncertainty about financing of the healthcare system are likely to become more prominent over the coming months and years and this is may create an increasingly negative outlook for the market.
Key Contacts
Our Relevant Experience
- Advising many innovative international pharmaceutical companies on strategic issues related to pricing and reimbursement in light of the multiple changes to pricing legislation.
- Advising various innovative international pharmaceutical companies in relation to regulations governing clinical trials, including drafting and revising different agreements and any supporting documents required in the performance of clinical trials.
- Advising several international pharmaceutical companies in relation to the transparency obligations and disclosure procedure required under Romanian legislation and the pharmaceutical industry disclosure codes, including revising all documents to be submitted to the relevant authorities.
- Advising and assisting large international pharmaceutical companies in relation to various internal investigations, including performing legal and forensic investigations, revision of information, interviewing employees, drafting investigation reports, assisting with revising and implementing internal standard operating procedures and providing legal and compliance training for employees.
- Advising and assisting various large international pharmaceutical companies on strategic issues relating to the healthcare assessment procedure and during the negotiation of cost-volume/cost-volume-result agreements.
- Advising and assisting various large international pharmaceutical companies on patient support programmes, national therapeutic programmes, outpatient healthcare, distribution of medicines outside the traditional distribution chains and administration with professional healthcare support.
Healthcare
Healthcare is an industry that affects everyone but it is, unfortunately, one that has a reputation for negative patient experiences. As a result, the patient experience is now becoming a focus of many healthcare companies and clinics and this is aided by new approaches and technology that have the power to transform healthcare.
Romania’s healthcare system has many shortcomings regarding patient rights, access to information, treatment waiting times, treatment outcomes, the range and reach of services provided and the prevention of ill health.
The local healthcare sector is affected by, and coping with, low spending, a shortage of staff and an all too high mortality rate. Out-of-pocket payments are the second largest source of revenue for the Romanian healthcare sector.
Cardiovascular disease and cancer are the cause of most deaths in Romania. The standardised death rate for acute myocardial infarction (AMI) is much higher than the EU average and, in 2014, was the highest in the EU. Cerebro-vascular disease in Romania has the second highest rate in the EU and contributes significantly to the overall mortality rate. At the same time, over 40% of disease and illness in Romania can be attributed to behavioural factors, including smoking, alcohol, diet and low physical activity.
Our Relevant Experience
- Acting as co-counsel for The Rohatyn Group on the investment in Amethyst Radiotherapy Limited, resulting in the former gaining co-control of the Company alongside the two co-founders.
- Advising and assisting an international company regarding the restructuring of a local hospital facility.
- Advising and assisting local and international healthcare professionals in relation to public and/or private local hospitals and clinics.
Key Contacts
Medical devices
The medical device sector is one of the biggest sectors in the healthcare industry and is driven by innovation and new technologies.
The last decade has seen an unprecedented growth in innovative and improved technologies that have, in turn, led to the development of state-of-the-art medical devices and increased growth and advancement in the healthcare industry.
With the increase in general healthcare spending in recent years, the Romanian medical device market has grown significantly. The market will, in all likelihood, remain heavily reliant on imports as the domestic industry mainly produces out-dated equipment that can only compete with foreign products on price rather than quality.
According to publicly available information, the Romanian medical device market is similar to that of the Ukraine in terms of market value and to Russia in terms of funds allocated per capita. The Romanian domestic market is also influenced by the significant growth of the private medical services market, which has been one of the fastest developing markets in Romania in recent years.
In 2016, the estimated value of Romania’s medical device market was EU 400 million and this is forecast to increase over the coming years.
Key Contacts
Our Relevant Experience
- Advising and assisting various international medical device manufacturers and distributors in relation to their commercial activity in Romania and the necessary authorisations required from the relevant authorities in this respect.
- Advising and assisting an international company concerning a local hospital’s restructuring process.
- Advising and assisting medical experts, locally and internationally, regarding their relationships with local public/private hospitals and clinics.
Crop Sciences
A continuously growing world population, changing eating habits and volatile weather conditions are three of the most prominent factors affecting global agricultural production today and into the future.
The world’s population increases by three people every second and, although this seems like an eminently manageable number, in 2050 when this second’s three new-borns are adults, an almost inconceivable 9.7 billion people will inhabit the Earth – that’s about one third more than currently do today.
In order to meet the major challenges of modern agriculture we need innovative solutions. Developing plants with a high tolerance to the increased volatility of worldwide weather conditions will be just as important as the development of innovative solutions for disease and pest control.
Considering the above, and evaluations performed by public authorities such as the National Sanitary Veterinary and Food Safety Authority, it is no exaggeration to say that in today’s world small farmers and their families on six of the seven continents are the people who feed the entire world.
Key Contacts
Animal Health
Animals, just like humans, suffer from disease and require proper care from qualified veterinarians, farmers and pet owners.
Improving the health of pets and livestock and treating them effectively is the foremost objective of the animal health industry. The industry broadly consists of two sectors – the production sector and the companion sector.
Every animal has distinct needs of its own and requires individualised treatment consistent with its breed. Further, based on available products, the animal health market is divided into three main areas: pharmaceuticals, biological and medicinal feed additives. Animal pharmaceuticals account for over half the overall animal health products market, followed by biological and the medicinal feed additives.
In Romania, the National Sanitary Veterinary and Food Safety Authority is responsible for veterinary pharmaceutical activities.
Key Contacts
Food, Nutrition & Supplements
Food, nutrition and supplement sales are stimulated by consumers’ increasing focus on health and well being which, in turn, leads individuals to take a more proactive approach to their health.
According to statistics, in 2017 multivitamins remained the most popular type of vitamins in Romania commanding the majority, in value terms, of retail sales. This suggests that consumers tend to take something of a catch-all approach when it comes to ensuring they get enough nutrients.
Vitamins and supplements are actively advertised, especially those well-known international brands using mass media, including national TV channels and print media. With constant reminders about their existence, these advertised brands usually maintain healthy sales.
Food, nutrition and supplement consumption in Romania will largely depend on the speed of the country’s economic recovery. If income levels are sufficient, Romanians will eagerly spend on such products based on the perceived health benefits.
Key Contacts
Health-Tech & Biotech
Advances in technology have created a new wave of products designed to improve patient care and comfort. Using connectivity and automation, these products alleviate some of the pressure on healthcare providers and help put patients in control.
Smart technology comes in a variety of forms – increasing comfort and efficiency and decreasing associated risks. Hospitals and clinics around the world are now using smart beds that self-adjust to the correct pressure and support for each individual patient’s condition and preferences. Others use robots to monitor a patient without the need for the physical presence of a healthcare professional. These type of smart devices and applications will continue to grow and spread throughout the healthcare field.
The medical sector is also taking advantage of technologies originally developed in other industries and adapting them to improve and broaden healthcare provision.
The role, and value, of medical technology is increasing in leaps and bounds as healthcare becomes ever more digital.
In addition, the pharmaceutical industry has made a great deal of progress over the last decade due to a research-orientated approach that has resulted in the improvement of technologies, developed infrastructures and increased research in the field of bio-science. It is with thanks to biotechnology, that various formulations have been developed to help cure or stop the growth of several major illnesses, including HIV and certain types of cancer.
With data taking centre stage both this year and going forward, artificial intelligence and block-chain technology is expected to expand significantly in the digital healthcare market. These innovations will, in all likelihood, include supporting clinical decision-making and identifying patient health risk factors in advance.
2019 is forecast to be the year when artificial intelligence really impacts the healthcare industry and some experts believe that the expansion of its use could well bring about a true healthcare revolution.
With the embracing of these new technologies by an increasingly digital healthcare market, traditional organisations will have to step-up their development and partner with technology providers.
Key Contacts
Our Relevant Experience
- Advised XVision, a MedTech start-up developing Artificial Intelligence algorithms for medical imaging, on a 1M EUR Seed Funding Round.
Cosmetics
The European cosmetics industry is a science-driven and highly innovative sector that plays a leading role in product development. Research and development programmes delve into all imaginable aspects of beauty and well being, from investigating consumer behaviour and beauty aspirations to the biology of skin, hair, teeth and mouths and then on to new innovative technologies and sustainable development methods. Every year, a quarter of all cosmetic products available on the market are either improved or completely new. Patent activity is a useful indicator of innovation, and a large proportion of patents granted in the EU are for the cosmetic industry’s products.
Ultimately, it is the consumers’ desire for new, better and safer products, delivered by dynamic and responsible companies, that drives the constant innovation in this industry.
Last year, the sale of cosmetics and perfume in Romania exceeded RON 5.5 billion or EUR 1.2 billion and the market still hasn’t reached its maximum potential. The sector includes around 2,000 companies with over 11,000 employees, numbers that have remained steady since 2009, showing a stable and well-defined market.
In Romania, most people still acquire their cosmetics products in physical stores, followed by pharmacies and finally beautician salons, although online sales have significantly increased in the last three years.
Consumers are increasingly conscious of the environment and the social and ethical ramifications of consumption and production. They expect businesses to share their concerns, which means that the industry must commit to the responsible use of resources in the development and production of all its products, giving rise to a whole new level of innovation across the entire industry.
