Freedom of information requests

Rare diseases and it's related clinical trials - Send to Heidi Gregory

Questions

Q1. Within your trust, how many patients currently have a diagnosis for:

• Fabry Disease (ICD10 code E75.21)
• Gaucher Disease (ICD10 code E75.22)
• Pompe Disease (ICD10 Code E74.02)
• Pompe Disease (ICD10 Code E74.02) Infantile-onset (Patients Diagnosed before age 1)
• MPS II (Hunter Syndrome) (ICD10 code E76.1)

Q2. Of the patients above, how many patients have been newly diagnosed within the past 3 months for:

• Fabry Disease (ICD10 code E75.21)
• Gaucher Disease (ICD10 code E75.22)
• Pompe Disease (ICD10 Code E74.02)
• Pompe Disease (ICD10 Code E74.02) Infantile-onset (Patients Diagnosed before age 1)
• MPS II (Hunter Syndrome) (ICD10 code E76.1)

 Q3. How many patients have been treated in the last 3 months with the following products:

• Replagal (agalsidase alfa)
• Fabrazyme (agalsidase beta)
• Galafold (migalastat)
• Elfabrio (pegunigalsidase alfa)
• VPRIV (velaglucerase alfa)
• Cerezyme (imiglucerase)
• Cerdelga (eliglustat)
• Zavesca (miglustat)
• Myozyme (alglucosidase alfa)
• Nexviadyme (avalglucosidase alfa)
• AT-GAA (cipaglucosidase alfa/miglustat)

Q4. Do you participate in any clinical trials for Fabry Disease? If so, can you please provide the name of each trial along with the number of patients taking part?

 

Q5. Do you participate in any clinical trials for Gaucher Disease? If so, can you please provide the name of each trial along with the number of patients taking part?

Response

The Trust does hold the information requested but we are withholding it for the following reason:

 

Refusal Notice – Section 14(1) of the Freedom of Information Act 2000

 

The right of access to information is not without exception and is subject to a number of exemptions and other provisions under the Act, including section 14(1) of the FOIA which provides:

 

"14. Vexatious and repeated requests

(1) Section 1(1) does not oblige a public authority to comply with a request for information if the request is vexatious."

 

In ICO Decision Notice FS50493150, the ICO clarified that the term vexatious is not defined in the FOIA.  The Upper Tribunal also considered the issue of vexatious requests in the case of the Information Commissioner v Devon County Council & Dransfield (Upper Tribunal Case No. GIA/3037/2011).

 

The Tribunal commented that vexatious could be defined as the 'manifestly unjustified, in appropriate or improper use of a formal procedure'. The Tribunal's definition clearly establishes that the concepts of proportionality and justification are relevant to any consideration of whether a request is vexatious.

We believe that the current request is vexatious because it will be burdensome to the

Trust, by virtue of S14(1) of the FOIA. There is no public interest test, so we have not

gone on to consider the same.

 

The Information Commissioner's Office (ICO) has provided guidance on dealing with

vexatious requests and states 'The Freedom of Information Act was designed to give individuals a greater right of access to official information with the intention of making public bodies more transparent and accountable. The ICO further recognises that 'dealing with unreasonable requests can place a strain on resources and get in the way of delivering mainstream services or answering legitimate requests. Furthermore, these requests can also damage the reputation of the legislation itself.

 

ICO guidance reminds public authorities that S14(1) is designed to protect public authorities by allowing them to refuse any requests which have the potential to cause a disproportionate or unjustified level of disruption. The ICO also states the emphasis on protecting public authorities' resources from unreasonable requests was acknowledged by the Upper Tribunal when it defined the purpose of S14 as 'section 14.....is concerned with the nature of the request and has the effect of disapplying the citizen's right under section 1(1).....the purpose of section 14......must be to protect the resources (in the broadest sense of that word) of the public authority from being squandered on disproportionate use of FOIA.....'

 

To assist public authorities, the ICO guidance has provided a number of indicators as typical key features of a vexatious request. These are:

• Burden on the authority
• Disproportionate effort
• Abusive or aggressive language
• Personal grudges
• Unreasonable persistence
• Unfounded accusations
• Intransigence
• Frequent or overlapping requests
• Deliberate intention to cause annoyance
• Scattergun approach
• No obvious intent to obtain information
• Futile requests
• Frivolous requests

 

Having reviewed your request, this repeats a previous request of FOI 3741 (responded in January 2024) changing only the period, however, this change in period is negligible when considering long-term drug treatment plans.  An annual or a longer period request would be more appropriate in this case, and less needlessly burdensome on already stretched NHS resources.  Although we understand that you may believe there to be serious purpose and value behind your request, we must consider whether the impact on the Trust is justified.

 

We have therefore determined that the following three factors are relevant in deeming your request vexatious:

• Burden on the authority
• Disproportionate effort
• Frequent or overlapping requests