Activities of Annalisa TARDINO related to 2023/0132(COD)
Shadow reports (1)
REPORT on the proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
Amendments (5)
Amendment 143 #
Proposal for a directive
Recital 2
Recital 2
(2) The most recent comprehensive revision took place between 2001 and 2004 while targeted revisions on post- authorisation monitoring (pharmacovigilance) and on falsified medicines were adopted subsequently. In the almost 20 years since the last comprehensive revision, the pharmaceutical sector has changed and has become more globalised, both in terms of development and manufacture. Moreover, science and technology have evolved at a rapid pace. However, there continues to be unmet medical needs, i.e. diseases without or only with suboptimal treatmentsor highly burdensome treatments, or with treatments targeting only sub-populations of a disease. Moreover, some patients may not benefit from innovation because medicines may be unaffordable or not placed on the market in the Member State concerned. There is also a greater awareness of the environmental impact of medicines. More recently, the COVID-19 pandemic has stress tested the framework.
Amendment 148 #
Proposal for a directive
Recital 3
Recital 3
(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; ensure access to innovative and established medicines forunder equal conditions for all patients, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; and create a balanced and competitive system that keeps medicines affordable for health systems while rewarding innovation.
Amendment 232 #
Proposal for a directive
Recital 50
Recital 50
(50) The establishment of a criteria- based definition of ‘unmet medical need’ is required to incentivise the development of medicinal products in therapeutic areas that are currently underserved. To ensure that the concept of unmet medical need reflects scientific and technological developments and current knowledge in underserved diseases, as well as the manifold aspects it encompasses, such as the potential of medicines to improve quality of life, ease the burden of care and take into account the scope (addressing only a sub- population of a disease) of therapies, where they exist, the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining high morbidity or mortality’, ‘'quality of life', relevant patient population’', 'access and scope (e.g. addressing only a sub-population of a disease) and ease of use of existing treatments' and 'severity of illness', following scientific assessment by the Agency. The Agency will seek input from a broad range of authorities or bodies – including relevant patient populations – active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004] and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, taking into account their complex nature and including all relevant aspects that determine the level of unmet medical need as listed above, burden of disease and priority setting for research and development. The criteria for ‘unmet medical need’ should be holistic, inclusive and take into account the many complex factors involved, and can be subsequently used by Member States to identify specific therapeutic areas of interest.
Amendment 758 #
Proposal for a directive
Article 47 – paragraph 1 – point d
Article 47 – paragraph 1 – point d
Amendment 1554 #
Proposal for a directive
Article 195 – paragraph 3
Article 195 – paragraph 3
3. A marketing authorisation may also be suspended, revoked or varied where the particulars supporting the application as provided for in Articles 6, 9 to 14 or Annexes I to V are incorrect or have not been amended in accordance with Article 90, or where any conditions referred to in Articles 44, 45 and 87 have not been fulfilled or where the controls referred to in Article 191 have not been carried out.