The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024
Introduction
The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 are a new piece of UK legislation that came into force on 31 October 2024. These regulations amend the existing Supplementary Protection Certificates (SPCs) regime in the UK, in order to implement the provisions of the Windsor Framework agreement between the UK and the EU.
Background
SPCs are a type of intellectual property right that can be granted to pharmaceutical and agrochemical products. They extend the period of protection for these products beyond the normal 20-year term of a patent. This is to compensate for the time lost during the development and regulatory approval process.
The Windsor Framework agreement was reached between the UK and the EU in October 2022. It set out a new framework for the UK’s relationship with the EU, including on intellectual property matters.
Amendments to the SPCs regime
The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 make a number of amendments to the existing SPCs regime in the UK. These amendments include:
- Extending the scope of SPCs – The regulations extend the scope of SPCs to cover new types of products, such as biologics and medical devices.
- Simplifying the application process – The regulations simplify the application process for SPCs, making it easier for businesses to obtain protection for their products.
- Reducing the time to grant – The regulations reduce the time it takes to grant SPCs, meaning that businesses can get protection for their products more quickly.
Impact of the regulations
The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 will have a number of positive impacts on the UK pharmaceutical and agrochemical industries. These include:
- Increased investment in research and development – The regulations will make it more attractive for businesses to invest in research and development in the UK, as they will be able to obtain longer protection for their products.
- Increased competitiveness – The regulations will help to level the playing field for UK businesses, by giving them access to the same SPCs regime as their competitors in the EU.
- Improved patient access to medicines – The regulations will help to ensure that patients have access to the latest and most innovative medicines, by making it easier for businesses to obtain SPCs for their products.
Conclusion
The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 are a significant piece of legislation that will have a positive impact on the UK pharmaceutical and agrochemical industries. The regulations will make it easier for businesses to obtain SPCs for their products, which will encourage investment in research and development, increase competitiveness, and improve patient access to medicines.
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