The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2025
These regulations amend the 2004 National Health Service regulations concerning prescription drugs.
Specifically, they update the list of drugs for erectile dysfunction, removing Tadalafil and Vardenafil while adding Cialis and Levitra, and remove notification requirements for prescribing Oseltamivir and Zanamivir.
These changes aim to improve efficiency and access to necessary medications while streamlining administrative processes.
Arguments For
Improved efficiency in healthcare: Streamlining the prescription process for certain drugs can lead to quicker access to necessary medication for patients.
Greater patient access to treatments: Removing restrictions on prescribing influenza antivirals allows for year-round availability, potentially improving public health outcomes.
Alignment with current medical practice: Updating the list of drugs for erectile dysfunction reflects advances in the market and ensures that regulations stay relevant.
Legal basis in the National Health Service Act 2006: The amendments are made under the authority granted by sections 88(1) and (2) and 272(7) and (8) of the NHS Act 2006, providing a strong legal foundation.
Arguments Against
Potential for increased drug misuse: Easier access to certain medications could lead to increased misuse and potential public health issues.
Unintended financial consequences: Changes in prescribing practices might impact the overall cost of healthcare provision.
Lack of consultation prior to enactment: Absence of widespread prior discussion could lead to oversight of potential negative effects.
Inadequate monitoring and evaluation: The lack clear mechanisms to monitor and evaluate the impact of these regulations may make it difficult to identify any unintended consequences.
- Citation, commencement, extent and application (1) These Regulations may be cited as the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2025. (2) These Regulations come into force on 1st October 2025. (3) These Regulations extend to England and Wales and apply in relation to England only.
This section details the title, effective date, and geographical scope of the regulations.
The regulations are titled the "National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2025" and will come into effect on October 1st, 2025.
They apply to England and Wales, but their application is limited to England.
- Amendments to Schedule 2 to the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004 In Schedule 2 to the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004 (drugs, medicines and other substances that may be ordered only in certain circumstances)— (a) in column 1 of the table (drugs), in the entry relating to drugs for the treatment of erectile dysfunction, omit “Tadalafil” and “Vardenafil”; (b) in column 1 of the table, in the entry relating to drugs for the treatment of erectile dysfunction, after the entry for “Avanafil” insert “Cialis” and “Levitra”; (c) in column 2 of the table (patient), in the entry relating to “Oseltamivir (Tamiflu)” omit sub-paragraph (a) in paragraphs (1) and (2) and in the entry relating to “Zanamivir (Relenza)” omit sub-paragraph (a) in paragraph (1).
This section outlines specific amendments to Schedule 2 of the 2004 regulations.
The amendments modify the list of drugs for treating erectile dysfunction by removing Tadalafil and Vardenafil and adding Cialis and Levitra.
Additionally, it removes a notification requirement for prescribing the influenza antiviral drugs Oseltamivir and Zanamivir.
Signed by authority of the Secretary of State for Health and Social Care Karin Smyth Minister of State Department of Health and Social Care at 3.00 p.m. on 1st September 2025
This section provides the signature and authority of the Minister of State from the Department of Health and Social Care, confirming the regulations' official adoption.
The regulations were signed on September 1st, 2025.
Explanatory Note (This note is not part of the Regulations) These Regulations amend the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004 (“the principal Regulations”). The principal Regulations make provision in respect of the drugs, medicines and other substances that may be ordered for patients in the provision of services under a general medical services contract within the meaning of section 84 of the National Health Service Act 2006. Regulation 2 makes amendments to the table in Schedule 2 to the principal Regulations (drugs, medicines and other substances that may be ordered only in certain circumstances) which restricts the circumstances in which certain drugs, medicines and other substances specified in column 1 of the table may be ordered for the category of patients described in column 2 of the table for the purposes specified in column 3 of the table. The entry in the table relating to certain drugs which may only be ordered for the treatment of erectile dysfunction in restricted circumstances has been amended so as to remove the generic drugs Tadalafil and Vardenafil, and include the brand names Cialis and Levitra. The effect of this amendment is that the restrictions continue to apply to these branded versions of these two erectile dysfunction drugs. Regulation 2 also removes the notification requirement in relation to the prescription of the influenza antiviral treatments Oseltamivir and Zanamivir, which has the effect of allowing year-round prescribing of these treatments if the other conditions in column 2 of Schedule 2 are met.
This explanatory note summarizes the regulations' purpose and key changes.
It clarifies that the amendments modify the 2004 regulations concerning the prescription of drugs and medicines.
The note details the specific changes made to the list of restricted drugs for erectile dysfunction and the removal of notification requirements for influenza antivirals, emphasizing that restrictions remain in place for the branded versions of these drugs.
It reiterates that the changes are intended to simplify the prescription process and improve access to necessary medications.
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