9 Amendments of Cyrus ENGERER related to 2023/0132(COD)
Amendment 160 #
Proposal for a directive
Recital 8
Recital 8
(8) This revision maintains the level of harmonisation that has been achieved. Where necessary and appropriate, it further reduces the remaining disparities, by laying down rules on the supervision and control of medicinal products and the rights and duties incumbent upon the competent authorities of the Member States with a view to ensuring compliance with legal requirements. In the light of experience gained on the application of the Union pharmaceutical legislation and the evaluation of its functioning, the regulatory framework need to be adapted to scientific and technological progress, the current market conditions and economic reality within the Union. Scientific and technological developments induce innovation and development of medicinal products, including for therapeutic areas where there is still unmet medical need. To harness these developments, the Union pharmaceutical framework should be adapted to meet scientific developments such as genomics, accommodate cutting edge medicinal products, e.g. personalised medicinal products, novel health treatments and technological transformation such as data analytics, digital tools and the use of artificial intelligence. These adaptations also contribute to competitiveness of the Union pharmaceutical industry.
Amendment 207 #
Proposal for a directive
Recital 44
Recital 44
(44) As regards access to medicinal products, previous amendments to the Union pharmaceutical legislation have addressed this issue by providing for accelerated assessment of marketing authorisation applications or by allowing conditional marketing authorisation for medicinal products for unmet medical need. While these measures accelerated the authorisation of innovative and promising therapies, these medicinal products do not always reach the patient and patients in the Union still have different levels of access to medicinal products. Patient access to medicinal products depends on many factors. Marketing authorisation holders are not obliged to market a medicinal product in all Member States; they may decide not to market their medicinal products in, or withdraw them from, one or more Member States. National pricing and reimbursement policies, the size of the population, the organisation of health systems and national administrative procedures are other factors influencing market launch and patient access. In addition, complex regulatory environment and associated administrative burden may prevent SMEs, research institutes and academic institutions developing promising innovative treatments from applying for conditional market authorization.
Amendment 212 #
Proposal for a directive
Recital 45 a (new)
Recital 45 a (new)
(45 a) Given the unmet needs in the area of mental health, the revision should also support early access to novel treatments for patients who need them most through means like compassionate use programmes and conditional marketing authorisation. These programs should play a pivotal role in providing treatment experience for providers and generating valuable real-world data to inform safety policies and future product labelling.
Amendment 213 #
Proposal for a directive
Recital 45 b (new)
Recital 45 b (new)
(45 b) Use of early access pilot programs to treat a diverse set of patients with complex comorbidities who are often excluded from clinical trials focused on novel mental health treatments should be supported. Allowing this would support gathering critical additional data on the safety and efficacy of these treatments in a broader population. Furthermore, these programs should explore different treatment protocols, such as group therapy and peer support specialists, to find the optimal balance of safety, efficacy, affordability, and equitable access.
Amendment 214 #
Proposal for a directive
Recital 45 c (new)
Recital 45 c (new)
(45 c) The revision should aim to support innovative mental health care treatments that combine pharmacological, and psychological aspects. Moreover, generation of empirical evidence for the quality and safety of novel mental health treatments should be further explored and supported. This includes understanding the interactions between the pharmacological substances and the psychotherapy as well as assistive technologies that can assist to patient preparation, monitoring or treatment integration.
Amendment 215 #
Proposal for a directive
Recital 45 d (new)
Recital 45 d (new)
(45 d) Mental health disorders also represent an area of unmet medical need, where only a moderate progress has been achieved during the past decades, especially in addressing the treatment resistant depression, treatment-resistant PTSD as well as regarding the neurodegenerative diseases. At the same time the mental health disorders pose a substantial burden on individuals, healthcare systems, caregivers, and economies.
Amendment 239 #
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, the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining high morbidity or mortality’, high prevalence with a particular attention to treatment resistance, ‘relevant patient population’ following scientific assessment by the Agency. The Agency will seek input from a broad range of authorities or bodies 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, burden of disease and priority setting for research and development. The criteria for ‘unmet medical need’ can be subsequently used by Member States to identify specific therapeutic areas of interest.
Amendment 798 #
Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1
Article 56 – paragraph 3 – subparagraph 1
The marketing authorisation holder of a medicinal product placed on the market in a Member State shall, within the limits of its responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors in accordance with Article 166 and 167, pharmacies orand persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.
Amendment 1578 #
Proposal for a directive
Article 206 – paragraph 2 – point e a (new)
Article 206 – paragraph 2 – point e a (new)
(e a) non-compliance with the obligations laid down in this Directive in Chapter V.