Masterstudiengang "Drug Regulatory Affairs"
The impact of changing legislation on the development, marketing authorisation and commercialization of medicinal products ***
Monique Mendel-Ott (Abschlußjahr: 2020)
Mostly triggered by tragedies related to the unsafe use of medicinal products, different regions of the world introduced at different moments in history an independent assessment process for new medicinal products before their entry into the market. The regulatory environment is in constant evolution due to continuous scientific development, experiences gained with tragedies associated with the unsafe use of medicinal products and with previous products. Recently, flexible regulatory adaptations were implemented due to corona virus disease (COVID-19).
The average cost for developing and launching an innovative product increased from $ 1.188 million in 2010 to $ 2.168 millions in 2018. Most of the investment for developing new products is made in the late stages of research and development, which has a high failure rate. Changing regulatory legislation might lead to the need to update an ongoing development program, thus impacting companies of different sizes and strategies at different degrees. Multi-regional clinical trials are often conducted by global researching companies. Scientific Advice/Protocol Assistance is essential to ensure that the data collected is accepted by various countries and especially beneficial when a lack of sufficient information is available from existing or draft guidelines.
A strategic lifecycle management of approved products is essential to recover the investment done during its development. Legislation changes might influence how the strategic regulatory decisions are made for an approved product. Data exclusivity might be prolonged by introducing a new indication with significant clinical benefit. Clinical trials to support the new indication might need to be repeated in case these are not in line with guidelines valid at submission. An ongoing development program of generic products might be affected by changing legislation either positively impacting the innovator or the generic product’s company, by either delaying or speeding product launch.
The entry into force of the EU Paediatric Regulation caused a significant impact to companies. Despite its benefits, the Paediatric-Use Marketing Authorisation (PUMA) does not normally result in attractive prices for the industry. The complexity and the needed expertise for the conduction of clinical trials in the paediatric population for products authorised under Article 8(3) of Directive 2001/83/EC might require companies to re-structure, re-locate, combine, create new or close existing departments with the aim of improving productivity.
Implementing measures to further strengthen internal Regulatory Intelligence and improve the relationship between industry and competent authorities support companies to overcome or better manage the challenges associated with changing regulatory legislation. Existing procedures and tools, such as Scientific Advice and Priority Medicines (PRIME) could be further improved by competent authorities in order to make interactions with industry better. The rolling review introduced due to the COVID-19 pandemic and measures to ensure higher Intellectual Property (IP) protection could be implemented in the future.
Changes in regulatory legislation are necessary to ensure access to safe and efficacious medicinal products to patients. Companies must adapt to changes and ensure the exchange of experiences with regulators to enable continuous improvement. A balance between patient needs/health care systems and the IP of companies should always remain the focus of any change in legislation.