The Applicant Guide: The Protection Of Data
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.
Since 2011, 3 systems have applied 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 2005 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 2005 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 Regulation 1107/2009 - data protection and data sharing
Regulation (EC) No 1107/2009 lays down rules for data protection for both active substance and product data, for the avoidance of duplicate testing, and for sharing of tests and studies involving vertebrate animals. They applied from 14 June 2011.
Avoidance of duplicate testing – provision of data lists & negotiations
Article 61 of the Regulation introduces general rules on the avoidance of duplicate testing. It requires prospective applicants for authorisation to consult details of products authorised in the relevant member State(s). Where authorised products contain the same active substance, safeners or synergist as the proposed product, applicants must request from the member State(s) a list of test and study reports such as those prepared in accordance with Article 60 (studies). Where an application is to be made, prospective applicants must also provide to the member State(s) all data regarding the identity and impurities of the active substance(s) and evidence that an application for authorisation is intended.
Requests for data lists from CRD should be made to Applicant Enquiries: See Contact Details Page. Once CRD is satisfied that the prospective applicant intends to apply for authorisation, or the renewal or review thereof, CRD will provide the list of studies, the name and address of the authorisation holder(s) (data owners) and at the same time alert the data owners of the name and address of the prospective applicant.
It is the responsibility of the prospective applicant and data owners to take all reasonable steps to reach an agreement on sharing of any tests and study reports. It is important that the context of those negotiations are clear to all parties; for example, prospective applicants should inform the data owner whether they are seeking authorisation of a new product in all or some member States, or UK only. Access negotiations conducted historically (eg for 'Step 1' re-registration purposes) may not be relevant to new product submissions.
Vertebrate data sharing provisions
Article 62 of the Regulation introduced new vertebrate data sharing provisions, in order to reduce the number of tests carried out on vertebrate animals. Member States must not accept duplication of tests and studies on vertebrate animals or those initiated where conventional methods described in Annex II to Directive 1999/45/EC could reasonably have been used. Article 62 also allows member States to use vertebrate studies for the purpose of the application of a prospective applicant who has not been able to reach agreement on sharing the data with the data owners.
Article 62(3) requires the prospective applicant and data owners to make 'every effort' to ensure that they share vertebrate tests and studies, and specifies that the costs must be determined in a 'fair, transparent and non-discriminatory way'. This is an obligation on the 2 parties concerned. CRD is not in a position to adjudicate in their negotiations and will not become involved in considering whether 'every effort' has been made or in determining the costs payable to the data owners. Where necessary, the parties may wish to consider participating in arbitration as an alternative dispute resolution procedure to resolve the terms of sharing vertebrate studies. CRD agreed the scheme with CEDR Solve (for the Chartered Institute of Arbitrators) for this purpose.
CRD has previously reserved the right to direct the parties to arbitration. Such directions to arbitration were intended to facilitate the arrangements in Directive 91/414/EEC, which encouraged sharing of vertebrate data. The arrangements in Regulation (EC) No 1107/2009, however, enable CRD to use vertebrate studies for the purpose of the application of the prospective applicant even if no agreement is reached. In these circumstances, there is no need or requirement for CRD to direct parties to arbitration.
Where CRD is informed by a prospective applicant that no agreement can be reached, CRD will access the relevant vertebrate studies to support their application for authorisation. In these cases, then data owners are able to claim from the prospective applicant a fair share of the costs of those studies and the data owners may issue proceedings in order to recover those costs. Prospective applicants may have to bear legal costs arising from any such proceedings.
Avoidance of duplicate testing – submission of applications
CRD note that on some occasions, prospective applicants obtain lists of protected studies from other sources (eg CRD website or the rapporteur member State), and they may contact the data owners direct without involving CRD. In those cases, CRD's first knowledge that negotiations relating to potential access to those data have taken place is when an application for authorisation is received. In these circumstances, applicants must confirm that they have taken the appropriate steps to negotiate access with the data owners. They should provide either the letter of access or (for vertebrate studies only) confirm that the two parties have failed to reach an agreement to share the data.
It is important that all applicants clarify the position on data access in the covering letter for their application, since CRD cannot accept an application without data or a letter of access, or (in the case of vertebrate studies) confirmation that negotiations on access have failed. The applicant should also identify in their covering letter whether they previously sought data lists as above.
Once CRD accept an application where the applicant identifies that negotiations have failed, CRD will write to the data owners to confirm that an application has been accepted on this basis.
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 (eg 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:
| 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, ie provisional to full approval | Five years from the date of new approval (ie 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 (ie 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 2005?
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 2005 approvals are summarised in the table below:
| 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:
| 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 (ie 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 is protected?
When we issue an authorisation, we will advise you in the accompanying letter as to whether the data you have submitted has 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 or for Approval under Regulation (EC) 1107/2009, is listed in the Review Report for that active substance
How do I make an application for a product citing data out of protection and/or via letter of access?
Article 34 of Regulation (EC) 1107/2009 exempts applicants from the need to supply supporting data when they are able to demonstrate that the Member State has already assessed relevant, supporting studies and one of the following conditions is met:
- The data protection period for all relevant supporting studies has expired (see guidance on Data Protection). or,
- The applicant is able to demonstrate access to the supporting studies. This may be where the applicant is also the owner of the original studies or it may be via a letter of access (go to guidance on Letters of Access).
When we assess this type of application we will check (where appropriate):
- That any new source of active substance is technically equivalent to the reference source, in accordance with SANCO Guidance Doc 10597/2003.
- That the new products formulation is sufficiently comparable to that of the reference product, in accordance with SANCO Guidance Doc 12638/2011.
- That the reference product assessment is still valid.
- That the data cited are either unprotected or have been correctly accessed with a valid letter of access.
Limitations when making an application citing Article 34 of Regulation (EC) 1107/2009
Applications must be made in accordance with the Applicant Guide what should i include in an application taking note of the following:
Where you are referring to data out of protection 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 reference source considered for approval under Regulation (EC) 1107/2009. If this is not the reference source, 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 reference product. This must either be a UK products (with MAPP number) or the representative formulation in the DAR. You may not refer to multiple reference products or multiple MAPP numbers. You must also make sure that the uses proposed for your new product are in line with those for the reference product.