Changes from plenary report to adopted text

Added1. Where an orphan marketing authorisation is granted and without prejudice to intellectual property law, the Union and the Member States shall not grant a marketing authorisation or extend an existing marketing authorisation, for the same therapeutic indication, in respect of a similar medicinal product for the duration of market exclusivity set out in paragraph 2.

Added2. The duration of market exclusivity shall be as follows:

Added(a) nine years for orphan medicinal products other than those referred to in points (b) and (c);

Added(b) teneleven years for orphan medicinal products addressing a high unmet medical need as referred to in Article 70; [Am. 204]

Added(c) fivefour years for orphan medicinal products which have been authorised in accordance with Article 13 of [revised Directive 2001/83/EC]. [Am. 205]

Added3. Where a marketing authorisation holder holds more than one orphan marketing authorisations for the same active substance, those authorisations shall not benefit from separate market exclusivity periods. The duration of the market exclusivity shall start from the date when the first orphan marketing authorisation was granted in the Union.

Added4. By way of derogation from paragraph 1, and without prejudice to intellectual property law, the marketing authorisation may be granted, for the same therapeutic indication, to a similar medicinal product if:

Added(a) the marketing authorisation holder for the original orphan medicinal product has given consent to the second applicant, or

Added(b) the marketing authorisation holder for the original orphan medicinal product is unable to supply sufficient quantities of the medicinal product, or

Added(c) the second applicant can establish in the application that the second medicinal product, although similar to the orphan medicinal product already authorised, is safer, more effective or otherwise clinically superior.

Added5. The submission, validation and assessment of the application for the marketing authorisation and granting the marketing authorisation for a generic or biosimilar product to the reference medicinal product for which market exclusivity has expired, shall not be prevented by the market exclusivity of a similar product to the reference medicinal product. [Am. 206]

Added6. The market exclusivity of the orphan medicinal product shall not prevent the submission, validation and, assessment of an application for, or the granting of, a marketing authorisation for a similar medicinal product, including generics and biosimilars, where the remainder of the duration of the initial market exclusivity is less than two years. [Am. 207]

Added7. Where the Agency adopts scientific guidelines for the application of paragraphs 1 and 4, it shall consult the Commission.

AddedArticle 72 Prolongation of market exclusivity

Added1. The periods of market exclusivity referred to in Article 71, paragraph 2, points (a) and (b), shall be prolonged by 12 months, where the orphan marketing authorisation holder can demonstrate that the conditions referred to in Article 81(2), point (a), and Article 82(1) [of revised Directive 2001/83/EC] are fulfilled.

AddedThe procedures set out in Articles 82(2) to (5) [of revised Directive 2001/83/EC] shall accordingly apply to the prolongation of market exclusivity. [Am. 208]

Added2. The period of market exclusivity shall be prolonged by an additional 12 months for orphan medicinal products referred to in Article 71(2), points (a) and (b), if at least two years before the end of the exclusivity period, the orphan marketing authorisation holder obtains a marketing authorisation for one or more new therapeutic indications for a different orphan condition.

AddedSuch a prolongation may be granted twice, if the new therapeutic indications are each time for different orphan conditions.

Added3. The orphan medicinal products which benefit from the prolongation of market exclusivity referred to in the paragraph 2 shall not benefit from the additional period of data protection referred to in Article 81(2), point (d), of [revised Directive 2001/83/EC].

Added4. Article 71(3) equally applies to the prolongations of market exclusivity referred to in paragraphs 1 and 2.

AddedArticle 73 Union financial contribution related to orphan medicinal products

AddedThe working arrangements referred to in Article 8 of [new fee Regulation] shall set out total or partial reductions for the applicable fees and charges payable to the European Medicines Agency as laid down in [new fee Regulation]. Such reductions shall be covered by the Union contribution provided for in Article 154(3), point (a) of this Regulation.

AddedArticle 73a Joint procurement of centrally authorised medicinal products

Added1. Upon request from the Member States, the Commission shall facilitate joint procurement of centrally authorised medicinal products at Union level on Member States' behalf.

Added2. The Commission is empowered to adopt delegated acts in accordance with Article 175 to supplement this Regulation by further defining the conditions and procedures for joint procurement of centrally authorised medicinal products. [Am. 209]

AddedArticle 73b Union Framework for Rare Diseases

AddedBy ... [24 months from the date of entry into force of this Regulation], the Commission shall, following a consultation with the Member States, patient organisations and other relevant stakeholders, propose a needs-driven and goals-based Union Framework for Rare Diseases with a view to better framing and coordinating Union policies and programmes, and supporting Member States in the elaboration of national strategies to better meet the unmet needs of people living with rare diseases, and their carers. [Am. 210]

AddedCHAPTER VII PAEDIATRIC MEDICINAL PRODUCTS

AddedArticle 74 Paediatric investigation plan

Added1. A paediatric investigation plan shall specify the timing and all the measures proposed to assess the quality, safety and efficacy of the medicinal product in all subsets of the paediatric population that may be concerned. In addition, it shall describe any measures to adapt the pharmaceutical form, the strength, the route of administration and the eventual administration device of the medicinal product so as to make its use more acceptable, easier, safer or more effective for different subsets of the paediatric population.

Added2. By derogation from paragraph 1, in the following cases an applicant may submit only an initial paediatric investigation plan as referred to in the second subparagraph:

Added(a) when the active substance concerned is not yet authorised in any medicinal product in the EU and is intended to treat a novel paediatric condition;

Added(b) following the acceptance by the Agency of a duly justified request from an applicant in accordance with paragraph 3. [Am. 211]

AddedAn initial paediatric investigation plan shall contain only the details and the timing of the measures proposed to assess the quality, safety and efficacy of the medicinal product in all subsets of the paediatric population that may be concerned, that are known at the moment of the submission of the request for agreement mentioned in Article 76(1).

AddedThis initial paediatric investigation plan shall also provide a precise timing of when updated versions of the paediatric investigation plan are to be submitted and when a final paediatric investigation plan complying with all the particulars described in paragraph 1, is expected to be submitted to the Agency.

Added3. When it is not possible, on the basis of scientifically justified reasons, to have a complete paediatric development plan in accordance with the timing given in Article 76(1) an applicant may submit a duly justified request to the Agency to utilise the procedure mentioned in paragraph 2. The Agency has 20 days to accept or refuse the request and shall immediately inform the applicant and state the reasons for refusal. [Am. 212]

Added4. On the basis of the experience acquired as a result of the operation of this Article or of scientific knowledge, the Commission is empowered to adopt delegated acts in accordance with Article 175 to amend the grounds for granting the possibility to utilise the adapted procedure foreseen in paragraph 2.

AddedArticle 75 Waivers

Added1. In accordance with the procedure set out in Article 78, the Agency may decide that the production of the information referred to in, Article 6(5), point (a), of [revised Directive 2001/83], shall be waived for products or for classes of medicinal products, if there is evidence showing any of the following:

Added(a) that the specific medicinal product or class of medicinal products is likely to be ineffective or unsafe in part or all of the paediatric population;

Added(b) that the disease or condition for which the specific medicinal product or class is intended occurs only in adult populations, unless when the product is directed at a molecular target thator due to its mechanism of action on the basis of existing scientific data, is responsible for a different disease or condition in the same therapeutic area in children than the one for which the specific medicinal product or class of medicinal products is intended for in the adult population; [Am. 213]

Added(c) that the specific medicinal product is likely to not represent a significant therapeutic benefit over existing treatments for paediatric patients.

Added2. The waiver provided for in paragraph 1 may be issued with reference either to one or more specified subsets of the paediatric population, or to one or more specified therapeutic indications, or to a combination of both.

Added3. On the basis of the experience acquired as a result of the operation of this Article or of scientific knowledge the Commission is empowered to adopt delegated acts in accordance with Article 175 to amend the grounds for granting a waiver detailed in paragraph 1. [Am. 214]

Added3a. The Agency shall, after consultation with the Commission and relevant interested parties, draw up guidelines for the application of this Article. [Am. 215]

AddedArticle 76 Validation of a paediatric investigation plan or of a waiver

Added1. A paediatric investigation plan or an application for waiver shall be submitted to the Agency with a request for agreement, except in duly justified cases, before the initiation of safety and efficacy clinical studies so as to ensure that a decision on use in the paediatric population of the medicinal product concerned can be given at the time of the marketing authorisation or other application concerned.

Added2. Within 30 days following receipt of the request referred to in paragraph 1, the Agency shall verify the validity of the request and communicate the result to the applicant.

Added3. Whenever appropriate, the Agency may ask the applicant to submit additional particulars and documents, in which case the time-limit of 30 days shall be suspended until the supplementary information requested has been provided.

Added4. In consultation with the Commission and with interested parties, the Agency shall draw up and publish guidelines for the practical application of this Article.

AddedArticle 77 Agreement on a paediatric investigation plan

Added1. After the validation of the proposed paediatric investigation plan referred to in Article 74(1).which is valid in accordance with the provisions of Article 76(2), the Agency shall adopt within 90 days a decision as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits, where appropriate also over existing treatments, justify the studies proposed. When adopting its decision, the Agency shall consider whether or not the measures proposed to adapt the pharmaceutical form, the strength, the route of administration and the eventual administration device of the medicinal product for use in different subsets of the paediatric population are appropriate.

Added2. After the validation of the proposed initial paediatric investigation plan prepared in accordance with the adapted procedure referred to in Article 74(2) first subparagraph, which is valid in accordance with the provisions of Article 76(2), the Agency shall adopt a decision within 70 days as to whether or not the paediatric investigation plan is expected to ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits, where appropriate also over existing treatments, justify the studies envisaged.

Added3. After receiving an updated version of the paediatric investigation plan referred to in Article 74(2), third subparagraph, the Agency shall review it within 30 days.

AddedAfter the timeframe laid down in the first subparagraph, without any request from the Agency in accordance with paragraph 5, the updated version of the paediatric investigation plan shall be considered as agreed.

Added4. When the final paediatric investigation plan referred to in Article 74(2), third subparagraph, is received, the Agency shall adopt within 60 days a decision on the paediatric investigation plan considering all the updated reviews eventually conducted and of the initial decision in accordance with paragraphs 2 and 3.

Added5. Within time periods referred to in paragraphs 1, 2, 3 or 4 the Agency may request the applicant to propose modifications to the plan or ask for additional information, in which case the time-limits referred to in paragraphs 1, 2, 3 and 4 shall be extended for a maximum of the same number of days. These time-limits shall be suspended until the supplementary information requested has been provided.

Added6. The procedure laid down in Article 87 shall apply for the adoption of decisions by the Agency.

AddedArticle 78 Granting of a waiver

Added1. An applicant may, on the grounds set out in Article 75(1), apply to the Agency for a product-specific waiver.