What is 'data protection'?
Data protection allows for a period of exclusivity of interest for data owners who have invested in the generation of data to support authorisations. Where appropriate, data submitted in support of an application and used to make a regulatory decision will be protected in line with the provisions of the legislation under which the application was evaluated. The protection periods vary depending on the type of authorisation issued.
During the course of the protection period, a third party cannot use protected data in support of an application for authorisation of their product, without the permission of the data owner (via a letter of access). Once the data are out of protection, we can use the data on behalf of a third party, without gaining permission to do so from the data owner.
From 14 June 2011, three systems will apply in the UK, reflecting the national rules (under the Control of Pesticides Regulations (COPR)) and the European systems under Council Directive 91/414/EEC and Regulation (EC) 1107/2009. The COPR and PPPR systems are similar in many ways, but the main points of each are described below. The system under Regulation (EC) 1107/2009 has attempted to simplify the procedure and data protection is repatriated to Member States.These summaries are intended only as a guide, however please contact us for advice if you have any queries in this area.
Under COPR and PPPR data protection only applies to data supporting a commercial authorisation. Data submitted in support of extension of use (off-labels), experimental approvals, import tolerance and adjuvant authorisations are not covered under these arrangements. These data will not be used for the benefit of any third party applications.
Under Regulation (EC) 1107/2009 data protection applies to data supporting a commercial authorisation and data submitted for the extension of authorisation for minor uses (off-labels). Moreover, once Regulations are in place in accordance with Articles 26, data protection shall also apply to safeners, synergists and adjuvants.
Vertebrate data sharing provisions
Under COPR and PPPR arrangements were put in place to ensure that tests involving vertebrates are not repeated unnecessarily. Details of this procedure are given in Regulatory Update 19/2005, Information Update 13/2006 and Regulatory Update 20/2009 .
Article 62 of Regulation (EC) 1107/2009 introduces new vertebrate data sharing provisions which allows Member States to use vertebrate studies on behalf of prospective applicants if an agreement with the holder(s) of the authorisation cannot be reached. Article (Article 62(3) states that the prospective applicant and authorisation holder(s) must make ‘every effort’ to ensure that they share vertebrate tests and studies and the costs must be determined in a ‘fair, transparent and non-discriminatory way’.
What constitutes ‘every effort’ has been discussed between Member States and the European Commission. It has been agreed that the prospective applicant should submit an official letter to the Member State demonstrating that they have made an attempt to gain access and have allowed sufficient time for the authorisation holder(s) to respond. It was also agreed to be good administrative practice that Member States contact the original notifier to confirm contact has been made. If no agreement has been reached then Member States may use the studies.
If no agreement can be reached and we are satisfied that the prospective applicant has made ‘every effort’ with the authorisation holder(s) then the studies will be used to allow authorisations. CRD is not in a position to adjudicate in commercial disputes. However, where companies are unable to reach agreement voluntarily, Regulation (EC) 1107/2009 allows the competent authorities to introduce national measures obliging the companies involved to share data using procedures specified by the authorities. Details of the current UK arbitration scheme can be found in the Applicant Guide.
Acceptance of duplicate studies
Article 62 (2) states that MS shall not accept the duplication of tests and studies on vertebrate animals or those initiated where conventional (calculation) methods could have been used. If vertebrate studies are submitted, they must be justified fully (see Article 8 (1) (d)). CRD will not accept studies without such justification from the applicant.
We will accept vertebrate studies generated prior to 14 June 2011, providing justification is submitted that demonstrates that the studies were generated in good faith and on the basis that no alternative approaches were available (for example following previous failed attempts to negotiate access under the previous legislation). We may also accept arguments for the submission of studies generated to support other regulatory regimes.
Vertebrate data sharing provisions - scope of studies
Recital 40 of Regulation 1107/09 refers to Council Directive 86/609/EEC, which in turn defines the type of experiments that are covered by the vertebrate data sharing arrangements. On this basis, CRD consider that field monitoring data (e.g. such as that conducted for higher tier bird and mammal assessments) are not within the scope of the vertebrate data sharing arrangements.
These vertebrate data sharing arrangements apply to all applications received from 14 June 2011.
What are the data protection periods for products considered under COPR?
The arrangements for data protection under COPR were first announced in 1991. They were agreed by Ministers, and structured so as to mirror the then developing EU system.
The protection periods applied to data submitted and used to support COPR approvals are summarised in the table below:
Data protection periods under COPR | Type of data | Period of protection |
| Active substance | Ten years from the date of first approval of the first product containing that active |
| Active substance data pre-COPR | Were protected until ten years from the start of COPR – thus unprotected since 6 October 1996 |
| Active substance data to support the continuing approval of that active, i.e. provisional to full approval | Five years from the date of new approval (i.e. that issued following evaluation of the additional data) or until original expiry date for active data (whichever is the longer) |
| Active substance data to support continuing approval – UK reviews | Five years from the date of official decision (departmental agreement for the review recommendations) or until original expiry date for active data (whichever is the longer) |
| Product data | Ten years from date of first approval of the product |
| Product data pre-COPR | Protected until ten years from start of COPR – thus unprotected since 6 October 1996 |
| Product/active substance data supporting a new use of an existing product | Ten years from date of first approval of product (i.e. no further protection for new use data) |
| Product data to support formulation change (resulting in a new product) | Ten years from date of approval of new product |
What are the data protection periods for products considered under PPPR?
The rules for data protection under Council Directive 91/414/EEC are set out in the legislation under Article 13 of the Directive. The protection periods applied to data submitted and used to support PPPR approvals are summarised in the table below:
Data protection periods under PPPR | Type of data | Period of protection |
| Active substance data for a new active substance | Ten years from the date of Annex I inclusion – protected data will be listed in the Review Report. The same period of protection applies across all Member States. |
| Active substance data for existing active substances | Five years from the date of Annex I inclusion – protected data will be listed in the Review Report (protected across all Member States). Any data used nationally prior to the review does not gain the 5 years protection |
| Active substance data to maintain or amend the Annex I inclusion | Five years from the date of the revised Annex I inclusion. This only applies to further, necessary information to support the continued/varied inclusion of an active substance on Annex I |
| Product data following Annex I inclusion | Ten years from date of first approval of any new product in any Member State following Annex I inclusion. |
| Product data required to reregister a product following Annex I inclusion | In line with original (national) expiry date for the product – no additional protection is given to new data required under Annex III of the Directive unless there has been a change in form of the product |
| Product data supporting a new use of an existing product | Following Annex I inclusion, ten years from date of approval for use (unlike COPR, new use data gain protection in their own right) |
| Product data to support formulation change (resulting in a new product) | Following Annex I inclusion, ten years from date of approval for new product |
What are the data protection periods for products considered under Regulation (EC) 1107/2009?
The rules for data protection under Regulation (EC) 1107/2009 are set out under Article 59. In order to be eligible for data protection the tests and study reports must be certified as compliant with the principles of good laboratory practice (GLP ) or good experimental practice (GEP) and the applicant must claim data protection for the tests and studies at the time of application.
The protection periods applied to data submitted and used to support authorisations (including extensions for minor uses as defined in Article 51(1)) under Regulation (EC) 1107/2009 are summarised in the table below:
Data protection periods under Regulation (EC) 1107/2009 | Type of data | Period of protection |
| Active substance and product data necessary for authorisation or amendment of an authorisation | Ten years from the date of the authorisation in each Member State, therefore different periods of protection will apply in each Member State. This will be extended to 13 years for products covered by Article 47 (low risk plant protection products). The above periods shall be extended by 3 months for each minor use as defined in Article 51(1). The minor use application must be made by the product authorisation holder and the minor use must be supported by data and not based on extrapolation. The application must be made within 5 years of the first product authorisation in the UK and the total data protection period for the product may not exceed 13 years which is extended to 15 years for products covered by Article 47. |
| Active substance and product data for renewal or review of an authorisation | 30 months from the date of the first authorisation in each Member State. This only applies to tests or studies necessary to support the continued/varied approval. |
| Data submitted in support of minor uses | Ten years from the date of the first product authorisation in each Member State, therefore different periods of protection will apply in each Member States. This will be extended to 13 years for products covered by Article 47 (low risk plant protection products). |
These data protection rules apply to all applications made from 14 June 2011 and being considered under Regulation (EC) 1107/2009). Transitional measures have been provided in Article 80 and allows Directive 91/414/EEC data protection rules (Articles 13(1) to 13(4)) to continue for active substances that were considered under Directive 91/414/EEC rules (i.e. those active substances that were included on Annex I or approved by virtue of Article 80(1)). However, as Article 80(2) also refers to Article 13(4) which refers to product data protection this allows Directive 91/414/EEC data protection for products containing active substances considered under Directive 91/414/EEC to continue.
How will I find out if data submitted with an application are protected?
When we issue an authorisation, we will advise you in the accompanying letter as to whether the data you have submitted have gained any protection. We may include a summary table of the data submitted and detail the periods of protection associated with each study. This information is only provided to the data owners, and is not publicly available unless requested under Article 60 of Regulation (EC) 1107/2009.
Data submitted for the purposes of Annex I inclusion under Directive 91/414/EEC or for Approval under Regulation (EC) 1107/2009, are listed in the Review Report for that active substance
How do I make an application for a product citing data out of protection?
Upon the expiry of the data protection periods, you may cite those data to meet requirements for authorisation of new products/uses, if it can be shown that those data are relevant to the new product and its uses.
When we assess this type of application we will check (where appropriate):
- that the new source of active substance is technically equivalent to the reference source, in accordance with Sanco Guidance Doc 10597/2003;
- that the new product (and its uses) are sufficiently comparable to the reference product(s) and that the required assessment standards are unchanged; and
- that the data cited are unprotected.
How can I determine whether active substance data are unprotected?
The Annex II list of protected studies attract protection for 10 years from date of entry into force for new actives, or 5 years from date of entry into force for existing actives. Inclusion dates are specified on the Inclusion Directive, and lists of protected studies are available from the Rapporteur Member State soon after inclusion (and many can be found on our website- see lists linked to the Re-Registration Guidance pages).
How can I determine whether product/use data are unprotected?
We cannot confirm whether product/use data are out of protection, other than by consideration of an application for authorisation (note we cannot do this via applicant enquiries). However, you can assess the likelihood that the data are unprotected based on the date the reference product was first marketed. You must remember that formulation changes may impact upon the data protection status for a product, and that changes in Ministry of Agriculture, Fisheries and Food (MAFF)/Ministerially Approved Pesticide Product (MAPP) numbers may reflect historical formulation changes.
Limitations when making an application citing data out of protection?
Applications must be made in accordance with the Applicant Guide taking note of the following:
You must fully explain your request in the covering letter, including why you believe the data supporting the source of the active substance and/or products/uses to which you are claiming equivalence/comparability are no longer protected.
You must provide details of the reference source of active substance, against which your new source will be assessed. This is usually the source considered for Annex I inclusion (or in the future the source approved under Regulation (EC) 1107/2009), if not you must give details of product name and MAPP number for a product containing that source.
You may only seek authorisation for one new source of active substance and one new product per application.
When determining comparability of products and uses, you must provide details of a maximum of two reference products per application. These must either be UK products (with MAPP numbers) or the representative formulation in the DAR. We will not consider non-UK products as one or both of your reference products. You must not make general reference to ‘any products containing the active substance’. You must also make sure that the uses proposed for your new product are in line with those for the reference product.
You may wish to consider the use of the two-staged application route
Avoidance of duplicate testing
Article 61 of Regulation (EC) 1107/2009 introduces general rules on the avoidance of duplicative testing which allows prospective applicants to request from Member States a list of test and study reports (prepared in accordance with Article 60) for a product which they have identified in accordance with Article 57 to have the same active substance(s). Such requests must be accompanied by all data regarding the identity and impurities of the active substance(s) and evidence that an application is intended. Once satisfied that the prospective applicant intends to apply for authorisation, or the renewal or review thereof, the name and address of the authorisation holder(s) shall be provided and at the same time the authorisation holder(s) shall be informed of the name and address of the prospective applicant. The prospective applicant and authorisation holder(s) should take all reasonable steps to reach an agreement on the sharing of any tests and study reports protected under Article 59.
Such requests to CRD should be made to applicant-enquiries@hse.gsi.gov.uk.
