Seventh Report Contents

Instruments of interest

Draft Road Transport (International Passenger Services) (Amendment) Regulations 2024

27.This draft instrument concerns market access arrangements between the UK and EU for bus and coach operators running international services. The Interbus Agreement provides a framework for international ‘occasional’ bus and coach services (such as holiday tours or private hire). The Protocol to the Interbus Agreement (RSR Protocol) extends this to cover ‘regular’ services (scheduled services with specified routes and fixed stopping points) and ‘special regular’ services (regular services for specific groups, such as school pupils), collectively termed RSR services. Following Brexit,, the road traffic passenger transport (RPT) chapter of the Trade and Cooperation Agreement replicated the provisions of the RSR Protocol (which was not yet in force for the UK or EU) on a temporary basis to secure market access provisions for UK-EU passenger transport. The provisions in the RPT chapter expire on 1 April 2025; this instrument would implement the RSR Protocol so these arrangements can continue.

28.Though it primarily maintains the status quo, two changes would result from this instrument. First, once the RSR Protocol comes into effect, UK bus and coach operators would be able to run RSR services which transit through the EU to reach non-EU states that have ratified the RSR Protocol (currently only Moldova and Bosnia and Herzegovina). The Department for Transport (DfT) expects this benefit for UK bus and coach operators to increase as more countries ratify the RSR Protocol over time. Second, this instrument would remove current cabotage rights for EU operators in Great Britain (GB), which means they would no longer be able to run services which start and end within GB. The DfT says this change would level the playing field between UK and EU operators because UK operators have not been able to provide cabotage services in the EU since Brexit. The RPT chapter will continue to allow cabotage arrangements for both occasional and RSR services on the island of Ireland, meaning a UK or EU operator can pick up and set down passengers in the territory of the other, to ensure continuity of passenger service availability.

Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (SI 2024/1075)

29.These Regulations amend assimilated law (previously known as retained EU law) on supplementary protection certificates (SPCs). According to the Intellectual Property Office (IPO), SPCs are valuable intellectual property rights which take effect when a patent expires. They provide up to five years of additional protection for patented human and veterinary medicines to reflect the fact that such products must undergo lengthy regulatory approval procedures during the patent lifetime before authorisations to place the products on the market can be granted, limiting the time in which research investment can be recouped.

30.The IPO explains that while under the original Withdrawal Agreement, EU law on medicines applied in Northern Ireland (NI), the Windsor Framework that was agreed by the UK and the EU in February 2023 provides for a UK-wide licensing regime for medicines. This means that the same medicinal products, in the same packs with the same labels, will be available across the whole of the UK, without the need for separate marketing authorisations and packaging requirements, and that the Medicines and Healthcare products Regulatory Agency will be able to authorise all medicines across the UK, including novel medicines such as cancer medicines. The changes made by this instrument allow SPCs to be granted based on the new arrangements for authorising human medicines on a UK-wide basis from 1 January 2025. In addition, transitional provisions will ensure that existing SPC applications and rights that were authorised under the previous arrangements are protected.





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