APPENDIX A
Agreement between the Association of the British
Pharmaceutical Industry (ABPI) and the National Institute for
Clinical Excellence (NICE) on guidelines for the release of company
data into the public domain during a health technology appraisal.
PRINCIPLES
1. NICE and ABPI acknowledge that it is
in the interests of patients and health professionals for all
relevant information about products being appraised to be put
into the public domain. Both accept, however, that the legal rights
of the owners of the data must be respected.
2. NICE has made a commitment not to place
in the public domain any information provided to it as commercial-in-confidence
during a technology appraisal prior to the launch of the product(s)
into the UK market.
3. Any reference in this Agreement to abstracts
shall assume the adoption of the CONSORT rules for the reporting
of clinical trials, and an equivalent standard for reporting economic
models.
4. In circumstances that warrant publication
of data regarded by the data owner as confidential, or the non-publication
of data normally available for publication in accordance with
these guidelines, both parties will negotiate in good faith to
seek to find a mutually acceptable solution, recognising the need
for NICE to support its recommendations with evidence and the
data owner's right to determine a global publication strategy.
5. It is recognised that in all cases the
data owner retains the right to make a final decision in relation
to the release of information into the public domain.
6. It is acknowledged that the principles
in this document apply to licence extensions as well as new chemical
entitles.
Data | Position
|
Clinical trial evidence | |
published | Any information, once published even in abstract form, can no longer be regarded as commercial in confidence (C in C).
|
unpublished
design
| ABPI policy encourages voluntary registration of specified information relating to the protocols of phase III trials involving patients in the UK and the current publication status three months after marketing in the first major market and prospective registration of phase IV and SAMM studies relating to the product.
|
results | Companies will authorise NICE to quote publicly from either a full report, or an unpublished abstract, where the date of release, by NICE, of such data is not less than 12 months after the "sign-off" by the relevant company. This 12 month restriction shall be the subject of negotiation in good faith between NICE and the company in the event that the licensing authority "fast track" an application leading to NICE requiring earlier publication.
|
Price | Pricing information will not be released, by NICE, into the public domain before product launch in the UK. In cases where NICE commissions an independent economic model companies will normally providein confidencethe price (or range of prices) expected. It is acknowledged that the final price of a product is often only determined immediately prior to launch.
|
Draft SmPC and EPAR | Whilst both the SmPCs and EPARs are public documents, draft versions cannot be published as changes may take place even for the indications right up to the last minute.
|
Final SmPC and EPAR | Public documents
|
Economic analysis | |
published | Any information, once published even in abstract form, can no longer be regarded as C in C but only to the extent of the data in the public domain.
|
unpublished | Companies will authorise NICE to quote publicly from either a full report or an unpublished abstract, where the date of release, by NICE, of such data is not less than 12 months after the sign-off by the relevant company. This 12 month restriction shall be the subject of negotiation in good faith between NICE and the company in the event that the licensing authority "fast track" an application leading to NICE requiring earlier publication.
|
model | Companies shall normally agree to their economic models being available to an independent academic group, in electronic form, for the purposes of a NICE technology appraisal. The model will be supplied in confidence and subject to suitable intellectual property protection. The terms of Principle 4 above shall specifically apply to any decision about availability of economic models.
|
| Similar arrangements apply to models produced as part of a NICE health technology assessment.
|
Budget/resource impact (including marketing/sales forecasts)
| Companies are encouraged to supply data from any projections they have prepared of uptake of their products in the NHS, at their own discretion, indicating which data should remain as commercial in confidence.
|
|