### (21) given the importance for the union citizens of quick access to environmental information , it is essential that member states and the commission make data publicly available as fast as technically feasible. to that end , whereas the precise reporting deadline is to be established in an implementing act , it should be no later than 11 months after the end of the reporting year. ### (21) given the importance for the union citizens of quick access to environmental information , it is essential that operators can directly input the required information within the portal through electronic input forms , subject to sub-sequent validation by the member states. the commission , assisted by the european environmental agency should make data publicly available as fast as technically feasible within the portal. to that end , whereas the precise reporting deadline is to be established in an implementing act , it should be no later than 1 month after the end of the reporting year.


### (25) public participation should be ensured in further development of the portal by providing early and effective opportunities to submit comments , information , analysis and opinions for the decision-making process. ### (25) real-time public participation should be ensured in further development of the portal by providing early and effective opportunities to submit comments , information , analysis and opinions for the decision-making process in order to identify the most sustainable and relevant solutions.


### (27) it should be possible for the commission to update the list of industrial or agricultural activities in relation to which reporting requirements apply. the commission should therefore be empowered to adopt delegated acts in accordance with article 290 of the treaty amending annex i to this regulation to add activities that have , or are expected to have , an impact on health or the environment and to align the annex with amendments to the protocol. ### (27) it should be possible for the commission to periodically update the list of industrial or agricultural activities in relation to which reporting requirements apply. the commission should therefore be empowered to adopt delegated acts in accordance with article 290 of the treaty amending annex i to this regulation to add activities that have , or are expected to have , an impact on health or the environment and to align the annex with amendments to the protocol , as well as unveiling activities that involve the adoption of measures ensuring compliance with the provisions in force , reducing their impact on health or the environment and setting a good example to other operators or businesses.


### (30) when adopting delegated acts , it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement of 13 april 2016 on better law-making58. in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states’ experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts. ### (30) when adopting delegated acts , it is of particular importance that the commission carry out regular , timely and appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement of 13 april 2016 on better law-making58. in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states’ experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts.


### 1. the portal shall include data on: ### 1. the portal shall include data at installation level , expressed in the same format as in the permits and bat conclusions or other metrics used in reference benchmarks , where applicable , on:


### 2. the portal shall include links to the following: ### 2. the portal shall integrate performance data and other pollution prevention information of the following:


### 1. the commission shall make the portal publicly accessible , presenting the data in both aggregated and non-aggregated forms with a view to enabling searches by: ### 1. the portal shall be established with a view to satisfy at least the following purposes:


### the environmental medium (air , water , land) into which the pollutant is released; ### the environmental medium (air , water , land) or combination of two or three of them , into which the pollutant is released;


### off-site transfers of waste and , as appropriate , their destination; ### off-site transfers of waste and , as appropriate , their destination , disaggregated by the type of the relevant r or d codes and differentiated by the respective eu waste code;


### 2. the portal shall be designed for maximum ease of public access to allow the data , under normal operating conditions , to be continuously and readily accessible on the internet. its design shall take into account the possibility of its future expansion and shall include all data reported for previous reporting years , up to at least the previous ten reporting years. ### 2. the portal shall be designed for maximum ease of public access to allow the data , under normal operating conditions , to be continuously and readily accessible on the internet. its design shall take into account the possibility of its future expansion and shall include all data reported for previous reporting years , up to at least the previous ten reporting years.


### use of water , energy and raw materials; ### use of water , energy and raw materials , as well as the quantities of waste resulting from the technological process;


### information allowing contextualisation of the data reported under points (a) to (d) , including production volume , number of employees , number of operating hours , and information on accidents that have led to releases; ### information allowing contextualisation of the data reported under points (a) to (d) , including production volume , number of employees , number of operating hours , and information on accidents that have led to releases , particularly those with cross-border implications;


### 3. operators shall obtain the data referred to in paragraph 1 by means of measurement. where measurement is not practicable , operators shall use calculation. where neither measurement nor calculation is practicable , operators may obtain the data by estimation. ### 3. operators shall obtain the data referred to in paragraph 1 by means of measurement. where measurement is not practicable , operators shall use calculation. where neither measurement nor calculation is practicable , operators may obtain the data by estimation , provided they specify each time the situation and the conditions for which one or other method is used.


### 7. the data referred to in paragraph 1 shall include releases and transfers reported as totals of all deliberate , accidental , routine and non-routine activities. in providing this data , operators shall specify , where available , any data that relate to accidental releases. ### 7. the data referred to in paragraph 1 shall include releases and transfers reported as totals of all deliberate , accidental , routine and non-routine activities. in providing this data , operators shall specify , where available , any data that relate to accidental releases , especially those with cross-border implications.


### 2. the public shall have the opportunity to submit comments , information , analyses and opinions within a reasonable timeframe. ### 2. the public shall have the opportunity to submit comments , information , analyses and opinions within a reasonable timeframe. the information , comments , analyses and opinions submitted must be translated into at least two other official languages of the union , including romanian , ensuring that all eu citizens have access thereto and the most suitable proposals for improving the portal can be adopted.


### reporting procedures; ### reporting procedures , which should be the same at european level;


### the data to be reported; ### the data to be reported and the deadlines for doing so;


### member states and the commission shall promote public awareness of the portal and understanding and use of the data contained in it. ### member states and the commission shall promote public awareness of the portal by means of information campaigns directed at various categories of recipient and understanding and use of the data contained in it.


### 2. the power to adopt delegated acts referred to in article 7(3) and article 14 shall be conferred on the commission for a period of five years from … [office of publication: please insert the date = the date of entry into force of this regulation]. the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period. ### 2. the power to adopt delegated acts referred to in article 7(3) and article 14 shall be conferred on the commission for a period of five years from [office of publication: please insert the date = the date of entry into force of this regulation]. the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period and regularly report to the parliament and council regarding the situation in the member states. where appropriate , these reports may also provide a basis for periodically updating the regulation. the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period.


### notwithstanding article 18 , first paragraph , regulation (ec) no 166/2006 shall continue to apply as regards reporting for the year 2024. ### notwithstanding article 18 , first paragraph , regulation (ec) no 166/2006 shall continue to apply as regards reporting for the year 2024.


### — having regard to the un environment programme (unep) latest emissions gap report 2021 entitled ‘the heat is on’ of 26 october 2021 , ### — having regard to the un environment programme (unep) latest emissions gap report 2021 of 1 november 2021 entitled ‘the heat is on’ of 26 october 2021 and adaptation gap report 2021 entitled 'the gathering storm';


### a. whereas health is fundamental to the well-being of europeans and equitable access to healthcare is a pillar of the eu; whereas safe , affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies , alongside investment and research; ### a. whereas health is fundamental to the well-being of europeans and equitable access to healthcare is a pillar of the eu; whereas safe , affordable medicines are needed to combat and prevent diseases; whereas patients should be at the centre of all health policies , alongside investment and research;


### a. whereas the pandemic has revealed the limitations of the current set-up for managing value chains and accessibility to medicines and vaccines; ### a. whereas the pandemic has revealed the limitations of the current set-up for managing value chains and accessibility to medicinal products , including vaccines; whereas ensuring the strategic autonomy in the field of medicines and diversifying pharmaceutical manufacturing and supply chains represents an essential step in effectively tackling future pandemics;


### b. whereas universal access to medicines is a fundamental right the full realisation of which is incompatible with a pharmaceutical model based primarily on the pursuit of profit; ### b. whereas universal access to medicines is a fundamental right , the full realization of which can be achieved through policy ecosystem that fosters medical innovation , to the benefit of patients and society as a whole;


### b. whereas universal access to medicines is a fundamental right the full realisation of which is incompatible with a pharmaceutical model based primarily on the pursuit of profit; ### b. whereas equitable access to safe , effective and affordable medicines is a fundamental right the full realisation of which is incompatible with a pharmaceutical model based primarily on the pursuit of profit;


### b. whereas universal access to medicines is a fundamental right the full realisation of which is incompatible with a pharmaceutical model based primarily on the pursuit of profit; ### b. whereas universal access to medicines is a fundamental right the full realisation of which is incompatible with a pharmaceutical model that uses intellectual property rights in a monopolistic way;


### c. whereas the pharmaceutical strategy covers the full cycle of medicines , including research , testing , authorisation , consumption and disposal , and contributes to meeting the objectives of the european green deal , the digital transformation and climate neutrality; ### c. whereas the pharmaceutical strategy covers the full life cycle of medicines , including collection and production of starting material , research , testing , manufacturing , authorisation , consumption and disposal , and contributes to meeting the objectives of the european green deal , the europe’s beating cancer plan , the digital transformation and climate neutrality;


### c. whereas the pharmaceutical strategy covers the full cycle of medicines , including research , testing , authorisation , consumption and disposal , and contributes to meeting the objectives of the european green deal , the digital transformation and climate neutrality; ### c. whereas the pharmaceutical strategy covers the full cycle of medicines and medical devices , including research , testing , authorisation , consumption and disposal , and contributes to meeting the objectives of the european green deal , the digital transformation and climate neutrality;


### 1. stresses that investment in research into and the development of innovative medicines and treatments , as well as access to safe , effective and high-quality medicines , are essential for making progress in the prevention and treatment of diseases; ### 1. stresses that fair and equitable access to safe , effective , high-quality and affordable healthcare services and treatments for all , as well as investment in research into and the development of innovative medicines and treatments , are essential for making progress in the prevention , diagnosis , treatment of diseases and quality of life of patients; regrets the disparities into the access to high quality healthcare services among member states and also between different regions within member states and asks the commission to address those disparities with the appropriate legislative measures in order to ensure equal rights in the eu;


### 1. stresses that investment in research into and the development of innovative medicines and treatments , as well as access to safe , effective and high-quality medicines , are essential for making progress in the prevention and treatment of diseases; ### 1. stresses that investment in research into and the development of innovative diagnostics and medicines and treatments , as well as access to safe , effective and high-quality medicines , are essential for making progress in the prevention and treatment of diseases; points out that embedding meaningful patient involvement throughout the entire life cycle of medicines and other therapies will be an indispensable requirement to achieve high-value innovation , patient benefit and patient safety; further underlines that eu funding programmes such as the future framework programme (horizon europe) must prioritize research on public health needs , especially those in the area neglected by the for-profit private sector , hence contributing to the development of medicines that bring actual added therapeutic value;


### 1. stresses that investment in research into and the development of innovative medicines and treatments , as well as access to safe , effective and high-quality medicines , are essential for making progress in the prevention and treatment of diseases; ### 1. stresses that investment in research into and the development of innovative medicines and treatments , as well as access to safe , effective and high-quality medicines , are essential for making progress in the prevention and treatment of diseases and for improving the quality of healthcare given to patients;


### 1. stresses that investment in research into and the development of innovative medicines and treatments , as well as access to safe , effective and high-quality medicines , are essential for making progress in the prevention and treatment of diseases; ### 1. stresses that investment in research into and the development of innovative medicines and treatments , as well as access to safe , effective and high-quality medicines , are essential for making progress in the prevention , diagnostics and treatment of diseases;


### 1. calls on the commission to work towards a european public biomedical infrastructure covering the entire medicines value chain and to develop the prospective european health emergency response authority (hera) along those lines; ### 1. calls on the commission to work towards a european public biomedical infrastructure covering the entire medicines value chain and to develop the prospective european health emergency response authority (hera) along those lines; recognises the importance of involving all stakeholders in the development and activities of hera as the positive public-private partnerships throughout the covid-19 pandemic;


### 2. considers that investment in research has not been sufficient to meet the therapeutic needs of patients with rare diseases , paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (amr); ### 2. underlines that investment in research should be further conditioned to public interest , recalls that public and private investments should be oriented with the necessary regulatory and legislative measures to meet the therapeutic needs of patients , including rare diseases , rare adult cancers and paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (amr);


### 2. considers that investment in research has not been sufficient to meet the therapeutic needs of patients with rare diseases , paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (amr); ### 2. considers that research and scientific progress has not yet produced sufficiently successful therapies for patients with rare diseases , chronic diseases , cancers , in particular paediatric cancers , and neurodegenerative diseases or to deal with antimicrobial resistance (amr);


### 2. considers that investment in research has not been sufficient to meet the therapeutic needs of patients with rare diseases , paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (amr); ### 2. considers that investment in research has not been sufficient to meet the therapeutic needs of patients with rare diseases , paediatric cancers and neurodegenerative diseases , deal with antimicrobial resistance (amr) concerning all amr pathogens , or prevent infectious diseases outbreaks;


### 2. considers that investment in research has not been sufficient to meet the therapeutic needs of patients with rare diseases , paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (amr); ### 2. considers that investment in research has not been sufficient to meet the therapeutic needs of patients with rare diseases , paediatric cancers , neurodegenerative diseases or chronic diseases , to deal with antimicrobial resistance (amr) or to deal with prevent infectious diseases;


### 2. considers that investment in research has not been sufficient to meet the therapeutic needs of patients with rare diseases , paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (amr); ### 2. considers that investment in research has not been sufficient to meet the diagnostic and therapeutic needs of patients with rare diseases , paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (amr);


### 2. calls on the commission to keep the results of union-funded r&d in the public domain; points out that the protection of patents must not run counter to the right to health; ### 2. calls on the commission to keep the results of union-funded r&d in the public domain; points out that the protection of patents must not run counter to the right to health; underlines that public interest and patient safety should be at the centre of all health policies , alongside investment and research;


### 3. considers it imperative that a common eu therapeutic guide for antimicrobials be introduced and that communication campaigns on amr be coordinated through a single calendar at eu level; ### 3. considers it imperative that a common eu therapeutic guide for antimicrobials be introduced and that communication campaigns on amr be coordinated through a single calendar at eu level; calls on the commission and member states to address amr with concrete and prompt measures , also with regulatory and legislative ones if needed;


### 3. calls on the commission to develop a new incentive model , look into decoupling mechanisms as an alternative to exclusive protections , and attach strict conditions to public funds in accordance with the principle of fair return on investment; ### 3. calls on the commission to develop a new incentive model , look into decoupling mechanisms as an alternative to exclusive protections , and attach strict conditions to public funds in accordance with the principle of fair return on investment and prioritisation of public interest;


### 3. calls on the commission to develop a new incentive model , look into decoupling mechanisms as an alternative to exclusive protections , and attach strict conditions to public funds in accordance with the principle of fair return on investment; ### 3. calls on the commission to develop a new targeted incentives in areas where the development of products would otherwise not be sustainable for companies such as transferable market exclusivities to stimulate the development of new antimicrobials , based on decoupling mechanisms;


### 4. calls on the commission to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs , prioritising projects promoted by the pharmaceutical industry combating rare diseases , paediatric cancers , neurodegenerative diseases and amr , with the aim of finding more therapeutic options and meeting the needs of patients and health systems; calls on the commission to promote the creation of an eu framework to guide and regularly evaluate the implementation of national plans to fight these diseases; ### 4. calls on the commission to revise the system of incentives and incorporate new criteria to promote public health driven research into and the development of new medicines for unmet therapeutic needs , as for example rare diseases , rare adult cancers and paediatric cancers , neurodegenerative diseases and amr , with the objective of protecting public health , guaranteeing equitable rights and access to treatment for all , finding more therapeutic options at affordable prices and meeting the needs of patients and health systems; calls on the commission to promote the creation of an eu framework to guide and regularly evaluate the implementation of national plans to fight these diseases;


### 4. calls on the commission to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs , prioritising projects promoted by the pharmaceutical industry combating rare diseases , paediatric cancers , neurodegenerative diseases and amr , with the aim of finding more therapeutic options and meeting the needs of patients and health systems; calls on the commission to promote the creation of an eu framework to guide and regularly evaluate the implementation of national plans to fight these diseases; ### 4. calls on the commission to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs , prioritising projects promoted by the pharmaceutical industry combating rare diseases , paediatric cancers , neurodegenerative and mental diseases and amr , with the aim of finding more therapeutic options and meeting the needs of patients and health systems; calls on the commission to promote the creation of an eu framework to guide and regularly evaluate the implementation of national plans to fight these diseases and on the member states to support research and development that focuses on the unmet medical needs of all citizens , and to guarantee non-exclusive licensing where r&;d is publicly funded and that access to medical advances in the european union is non-discriminatory;


### 4. calls on the commission to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs , prioritising projects promoted by the pharmaceutical industry combating rare diseases , paediatric cancers , neurodegenerative diseases and amr , with the aim of finding more therapeutic options and meeting the needs of patients and health systems; calls on the commission to promote the creation of an eu framework to guide and regularly evaluate the implementation of national plans to fight these diseases; ### 4. calls on the commission to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs , prioritising projects promoted by the pharmaceutical industry combating rare diseases , paediatric cancers , neurodegenerative diseases and amr , with the aim of finding more therapeutic options and meeting the needs of patients and health systems; calls on the commission to promote the creation of an eu framework to guide and regularly evaluate the implementation of national plans to fight these diseases; recalls the need to facilitate access to treatment across borders for patients with rare diseases when not available in their country of origin;


### 4. calls on the commission to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs , prioritising projects promoted by the pharmaceutical industry combating rare diseases , paediatric cancers , neurodegenerative diseases and amr , with the aim of finding more therapeutic options and meeting the needs of patients and health systems; calls on the commission to promote the creation of an eu framework to guide and regularly evaluate the implementation of national plans to fight these diseases; ### 4. calls on the commission to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs , prioritising public interests and patient safety when assessing projects promoted by the pharmaceutical industry in order to combat rare diseases , cancers , including paediatric cancers , neurodegenerative diseases and amr , with the aim of finding more therapeutic options and meeting the needs of patients and health systems; calls on the commission to promote the creation of an eu framework to guide and regularly evaluate the implementation of national plans to fight these diseases;


### 4. calls on the commission to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs , prioritising projects promoted by the pharmaceutical industry combating rare diseases , paediatric cancers , neurodegenerative diseases and amr , with the aim of finding more therapeutic options and meeting the needs of patients and health systems; calls on the commission to promote the creation of an eu framework to guide and regularly evaluate the implementation of national plans to fight these diseases; ### 4. calls on the commission to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs , prioritising projects combating rare diseases , paediatric cancers , neurodegenerative diseases , chronic diseases , amr , prevent infectious diseases , with the aim of finding more therapeutic options and meeting the needs of patients and health systems; calls on the commission to promote the creation of an eu framework to guide and regularly evaluate the implementation of national plans to fight these diseases;


### 5. calls on the commission to promote dialogue with the member states and stakeholders to assess new criteria for national pricing , such as whether a product is ‘made in europe’ , whether the eu invested in the product to support research , or whether prices should be adapted to the value of the therapeutic benefit of the medicine , and the primary and broader needs of the population; ### 5. calls on the commission to promote a dialogue to assess new criteria for negotiating national pricing , such as whether a product is ‘made in europe’ , whether the eu invested in the research and development of the product , while promoting an analysis as well on what constitutes a socially acceptable profit margin for pharmaceutical products; recalls that national pricing should be based on transparency of factors such as public and private research , development costs and added therapeutic value; calls for the timely development by the commission and member states of guidelines on principles and costing methods for establishing the research and development costs of medicines and their use at the national level;


### 5. calls on the commission to promote dialogue with the member states and stakeholders to assess new criteria for national pricing , such as whether a product is ‘made in europe’ , whether the eu invested in the product to support research , or whether prices should be adapted to the value of the therapeutic benefit of the medicine , and the primary and broader needs of the population; ### 5. calls on the commission to promote dialogue with the member states and stakeholders to assess additional criteria for national pricing , such as whether the supply chain management is sufficiently resilient and robust; whether there have been investments in innovation and/or high environmental manufacturing standards; whether a product is ‘made in europe’; whether the eu invested in the product to support research , or whether prices should be adapted to the costs as well as to the value of the therapeutic benefit of the medicine , and the primary and broader needs of the population;


### 5. calls on the commission to promote dialogue with the member states and stakeholders to assess new criteria for national pricing , such as whether a product is ‘made in europe’ , whether the eu invested in the product to support research , or whether prices should be adapted to the value of the therapeutic benefit of the medicine , and the primary and broader needs of the population; ### 5. calls on the commission to promote dialogue with the member states and stakeholders to assess new criteria for national pricing and to include procurement criteria in national tenders such as "resilient and robust supply chains management" , investment in research , development and manufacturing within the union (made in europe) , whether the eu invested in the product to support research , or whether prices should be adapted to the value of the therapeutic benefit of the medicine , and the primary and broader needs of the population;


### 5. calls for public investment in r&d to be made transparent and for it to be reflected in product availability and pricing; ### 5. calls for public investment in r&d to be made transparent and for it to be reflected in product availability and pricing; calls in this regard on the commission to increase price transparency when it comes to the costs calculated in the prices , while also addressing the causes limiting affordability;


### 5. calls for public investment in r&d to be made transparent and for it to be reflected in product availability and pricing; ### 5. calls for the inclusion of public investment in drug r&d , and for it to be reflected in product availability and pricing;


### 6. calls on the commission to review the incentive system , increase price transparency , highlight the causes limiting affordability and patient access to medicinal products , and propose sustainable solutions that also promote competition; ### 6. calls on the commission to work with member states and medicine marketing authorization holders to identify and address the root-causes of unavailability of medicines , and find adequate solutions to address the outstanding barriers to timely and effective patient access; calls on the commission to enhance affordability based on the fundamental pricing principle of solidarity across member states and to increase price transparency via a revision of the transparency directive in order to include voluntary/secret agreements , public procurement and generic medicines;


### 6. calls on the commission to review the incentive system , increase price transparency , highlight the causes limiting affordability and patient access to medicinal products , and propose sustainable solutions that also promote competition; ### 6. calls on the commission to review the incentive system , increase price transparency , also via a revision of the transparency directive in order to include voluntary/secret agreements , public procurement and generic medicines , highlight the causes limiting affordability and patient access to medicinal products , and propose sustainable solutions that also promote competition; recalls that all public funding must be made conditional on the full transparency and traceability of investments , on supply obligations on the eu market , to ensure accessibility and affordability of manufactured medicines in the eu and to guarantee fair return of public investments;


### 6. calls on the commission to review the incentive system , increase price transparency , highlight the causes limiting affordability and patient access to medicinal products , and propose sustainable solutions that also promote competition; ### 6. calls on the commission to review the incentive system , increase price transparency , highlight the causes limiting affordability and patient access to medicinal products , and propose sustainable solutions that also promote competition; in the same vein asks the commission to work together with member states and industry to identify and address the root-causes of unavailability of medicines in order to find solutions to address the outstanding barriers to timely and effective patient access;


### 6. calls on the commission to review the incentive system , increase price transparency , highlight the causes limiting affordability and patient access to medicinal products , and propose sustainable solutions that also promote competition; ### 6. calls on the commission to review the incentive system , increase price transparency , highlight the causes limiting affordability and patient access to medicinal products , and propose sustainable solutions that also promote competition; in this regard , calls on the commission to submit a legislative proposal on transparency of decisions regulating the prices and the reimbursement of medicinal products in eu countries;


### 6. calls on the commission to review the incentive system , increase price transparency , highlight the causes limiting affordability and patient access to medicinal products , and propose sustainable solutions that also promote competition; ### 6. calls on the commission to review the incentive system , increase price transparency , conduct an assessment of the causes limiting affordability and patient access to medicinal products , and propose sustainable solutions that also promote competition;


### 7. stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the commission to introduce measures to support a greater market presence of these medicines and to harmonise at eu level the interpretation of the so-called bolar provision concerning possible exemptions from the legal framework for the unitary patent system for generic drug manufacturers; further calls on the commission to design rules for the industry that promote research , development and the production of generic and biosimilar medicines in the eu and to propose eu protocols for the interchangeability of biosimilar medicines; ### 7. stresses that generic and biosimilar medicines are accessible and affordable treatments , allowing a broader competition and contributing greatly to the budgetary sustainability of healthcare systems , thus helping to improve access to treatment for patients; calls on the commission to introduce legislative and non-legislative measures to support a greater market presence of these medicines and their timely access to markets across the eu; regrets that generic and biosimilar alternatives are often not available in low and middle income member states where they might be needed most; deplores the litigation cases aimed at delaying generic entry and calls on the commission to address any misuse of the ipr system to delay entry of generic and biosimilar medicines into the market; calls on the commission to ensure that the end of the innovator’s period of commercial exclusivity is respected in order to make treatments available to patients as swiftly as possible;


### 7. stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the commission to introduce measures to support a greater market presence of these medicines and to harmonise at eu level the interpretation of the so-called bolar provision concerning possible exemptions from the legal framework for the unitary patent system for generic drug manufacturers; further calls on the commission to design rules for the industry that promote research , development and the production of generic and biosimilar medicines in the eu and to propose eu protocols for the interchangeability of biosimilar medicines; ### 7. stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the commission to introduce measures to support a greater market presence of these medicines and to harmonise at eu level the interpretation of the so-called bolar provision concerning possible exemptions from the legal framework for the unitary patent system for generic drug manufacturers; further calls on the commission to design rules for the industry that promote research , development and the production of generic and biosimilar medicines in the eu , to propose eu protocols for the interchangeability of biosimilar medicines , and to ensure healthy competition at the expiry of intellectual property exclusivities by removing all barriers to access competition , such as patent linkage and banning ip evergreening practices that unduly delay access to medicines and allowing single global development;


### 7. stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the commission to introduce measures to support a greater market presence of these medicines and to harmonise at eu level the interpretation of the so-called bolar provision concerning possible exemptions from the legal framework for the unitary patent system for generic drug manufacturers; further calls on the commission to design rules for the industry that promote research , development and the production of generic and biosimilar medicines in the eu and to propose eu protocols for the interchangeability of biosimilar medicines; ### 7. stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems by providing more treatment options and potentially by helping reduce medicine shortages; calls on the commission to introduce measures to support a greater market presence of these medicines and to harmonise at eu level the interpretation of the so-called bolar provision concerning possible exemptions from the legal framework for the unitary patent system for generic drug manufacturers; further calls on the commission to design rules for the industry that promote research , development and the production of generic and biosimilar medicines in the eu and to propose eu protocols for the interchangeability of biosimilar medicines;


### 7. stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the commission to introduce measures to support a greater market presence of these medicines and to harmonise at eu level the interpretation of the so-called bolar provision concerning possible exemptions from the legal framework for the unitary patent system for generic drug manufacturers; further calls on the commission to design rules for the industry that promote research , development and the production of generic and biosimilar medicines in the eu and to propose eu protocols for the interchangeability of biosimilar medicines; ### 7. stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the commission to introduce measures to support a greater market presence of these medicines and to harmonise and widen at eu level the interpretation of the so-called bolar provision concerning possible exemptions from the legal framework for the unitary patent system for generic drug manufacturers; further calls on the commission to design rules for the industry that promote research , development and the production of generic and biosimilar medicines in the eu and to propose eu protocols for the interchangeability of biosimilar medicines , as defined by the european medicines agency;


### 7. calls on the commission to promote joint procurement and apply most economically advantageous tender (meat) criteria more stringently; ### 7. calls on the commission to promote joint procurement favourable to all member states and apply most economically advantageous tender (meat) criteria more stringently , while taking into account the need for more balance between public and private interests , including clear liability for manufacturers , as well as the need for sufficient flexibility for member states in line with national specificities; underlines the importance to improve security of supply and to enhance eu countries' preparedness to mitigate cross-border threats to health;


### 7. calls on the commission to promote joint procurement and apply most economically advantageous tender (meat) criteria more stringently; ### 7. calls on the commission to promote joint procurement and apply most economically advantageous tender (meat) criteria more stringently with the same clinical value; it must be ensured that joint procurements comply with the conditions laid down by directive 2014/24 / eu , in order to ensure long term sustainability , competition , security of supply and stimulating investments in manufacturing;


### 8. welcomes the fact that the commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; further welcomes the fact that the commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the need to reduce medicine approval times at national level and align them with european medicines agency (ema) times , in order to ensure rapid and equal access to medicines for everyone in the eu; ### 8. welcomes the fact that the commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market and also recalls the importance of addressing the issue of disparities in the availability of certain medicines due to discontinuation of products or withdrawals from less profitable markets of some member states , where patients do not have access to treatments due to commercial decisions made by pharmaceutical companies and mahs; calls on the commission and member states to implement the necessary measures in order to make centrally authorised medicines timely available to patients without any further delay and calls on the commission to tackle the problem of diverging market launches by linking the centralised marketing authorization to commitments on the part of pharmaceutical companies to not delay the availability of the product in any member state; further welcomes the fact that the commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition and calls on the commission to further develop capabilities to investigate potential anti-competitive practices; stresses the need address the reasons why the medicine approval time is so heterogeneous across the eu and to reduce medicine approval times at national level and align them with european medicines agency (ema) times , when considered safe and beneficial for patients , in order to remove any obstacle to a rapid and equitable access to medicines for all in the eu; emphasises that any revision of the regulatory procedures and approaches to the assessment of scientific evidence must be cautiously undertaken in order to adequately take patient benefit and safety aspects into consideration;


### 8. welcomes the fact that the commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; further welcomes the fact that the commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the need to reduce medicine approval times at national level and align them with european medicines agency (ema) times , in order to ensure rapid and equal access to medicines for everyone in the eu; ### 8. welcomes the fact that the commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; stresses the need of a complementary study looking into multi-factorial causes of access delays and inequality; further welcomes the fact that the commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the need to reduce medicine approval times at national level and align them with european medicines agency (ema) times , in order to ensure rapid and equal access to medicines for everyone in the eu;


### 8. welcomes the fact that the commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; further welcomes the fact that the commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the need to reduce medicine approval times at national level and align them with european medicines agency (ema) times , in order to ensure rapid and equal access to medicines for everyone in the eu; ### 8. welcomes the fact that the commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; further welcomes the fact that the commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the need for member states to work towards making centrally authorised medicines available to patients as close to the european medicines agency (ema) approval times as possible , in order to ensure rapid and equal access to medicines for everyone in the eu and avoid discrimination between eu citizens;


### 8. regrets the excessive influence of industry interest groups , which is detrimental to public-health , patient and consumer associations and to trade unions. ### 8. encourages the active involvement of public health organizations and societies , patient and consumer associations , as well as trade unions;


### 9. highlights the benefits of public-private partnership tenders for national health systems in funding research into and the production of innovative medicines; ### 9. highlights the role of public-private partnership tenders for national health systems in funding research into and the production of innovative medicines; recalls that any ppps must produce results in the interest of patients , maximise public return on public investment and respect the principles of transparency , traceability and affordability;


### 10. stresses the importance of new joint eu public procurement contracts by the commission and the member states , especially for emergency medicines and unmet therapeutic needs; ### 10. stresses the importance of new joint eu public procurement contracts by the commission and the member states , especially for emergency medicines and unmet therapeutic needs; emphasises the importance of diversified supplies and procurement practices for pharmaceuticals; urges the commission , in the context of directive 2014/24/eu , to swiftly propose guidelines for the member states , notably on how to best implement the most economically advantageous tender (meat) criteria , looking beyond the lowest price criteria only; proposes that investments in the manufacture of active ingredients and medicinal end products in the eu should also be retained as a criterion , as well as the number and location of production sites , the reliability of supply , the reinvestment of profits into r&d and the application of social , environmental , ethical and quality standards; notes that procurement procedures with only one successful tenderer and/or only one production site of the basic substance may exacerbate vulnerability should supplies be disrupted; calls on the commission and the member states to consider introducing procurement procedures under which contracts may be awarded to a number of successful tenderers , including joint tenderers;


### 10. stresses the importance of new joint eu public procurement contracts by the commission and the member states , especially for emergency medicines and unmet therapeutic needs; ### 10. stresses the need for joint eu public procurement contracts by the commission and the member states , especially for , but not limited to , emergency medicines and unmet therapeutic needs; underlines the need to ensure high levels of transparency in these initiatives and apply lessons learned from joint procurement of covid-19 vaccines;


### 10. stresses the importance of new joint eu public procurement contracts by the commission and the member states , especially for emergency medicines and unmet therapeutic needs; ### 10. stresses the importance of new joint eu public procurement contracts by the commission and the member states , especially for , but not limited to , emergency medicines and unmet therapeutic needs;


### 11. is concerned that the affordability of medicines remains a challenge for national health systems , and that innovative medicines are expensive; welcomes the commission’s intention to review pharmaceutical legislation to promote robust competition and to stabilise and balance national drug pricing systems; ### 11. is concerned that accessibility and affordability of medicines remain a challenge for national health systems , and that innovative medicines are expensive or not even launched in certain member states for commercial reasons; welcomes the commission’s intention to review pharmaceutical legislation to promote robust and fair competition and to promote fair national drug pricing systems; stresses the need to link any form of incentive to affordability clauses in order to ensure equal and fair pricing of pharmaceuticals , particularly innovative ones; calls for an increased transparency on research costs incurred for pharmaceutical development to better adjust the pricing mechanism to the actual costs; calls on the commission and member states in this regard to establish a framework for reporting research cost as regards pharmaceutical development;


### 11. is concerned that the affordability of medicines remains a challenge for national health systems , and that innovative medicines are expensive; welcomes the commission’s intention to review pharmaceutical legislation to promote robust competition and to stabilise and balance national drug pricing systems; ### 11. is concerned that the affordability of medicines remains a challenge for national health systems , that innovative medicines are expensive , and that the ability to pay remains very divergent across eu member states , leading to unequal access to medicines for eu citizens; welcomes the commission’s intention to review pharmaceutical legislation to promote robust competition , to stabilise and balance national drug pricing systems , and to ensure more equitable access for patients across member states;


### 11. is concerned that the affordability of medicines remains a challenge for national health systems , and that innovative medicines are expensive; welcomes the commission’s intention to review pharmaceutical legislation to promote robust competition and to stabilise and balance national drug pricing systems; ### 11. is concerned that the affordability of medicines remains a challenge for national health systems , and that innovative medicines are expensive; welcomes the commission’s intention to review pharmaceutical legislation to promote robust and timely competition and to stabilise and balance national drug pricing systems in order to ensure more equitable access for patients within the union;


### 12. insists that a competitive eu pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable , flexible and agile regulatory environment; believes that it can thrive globally with a clear , robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the european health data space; ### 12. insists that public responsibilities fall upon the eu pharmaceutical industry and that its competitiveness is strategic for functioning and effective healthcare systems in the eu and for public authorities to be more responsive to patients’ needs and protect public health; points out a predictable and agile regulatory environment is beneficial to address the needs of patients and to create a better environment for innovation and drugs development; welcomes the initiative to build interoperable digital infrastructure for the european health data space; underlines that a harmonised interpretation of the general data protection regulation (gdpr) in all eu member states is the foundation for such initiatives;


### 12. insists that a competitive eu pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable , flexible and agile regulatory environment; believes that it can thrive globally with a clear , robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the european health data space; ### 12. insists that a competitive eu pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable , flexible and agile regulatory environment; believes that the current intellectual property system should be reviewed in order to ensure that it incentives innovation , while ensuring a universal and equitable access to medicinal products , especially in emergency situations; welcomes the initiative to build interoperable digital infrastructure for the european health data space;


### 12. insists that a competitive eu pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable , flexible and agile regulatory environment; believes that it can thrive globally with a clear , robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the european health data space; ### 12. insists that a competitive eu pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable , flexible and agile regulatory environment and that should build on the existing framework and prevent duplication and additional bureaucratic burdens; believes that it can thrive globally with a clear , robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the european health data space to leverage the full potential of real-world-date and access to rare therapies;


### 13. calls on the commission to revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the eu; ### 13. calls on the commission to revise the use of supplementary protection certificates based on technological and scientific advances to allow generic and biosimilar medicines to become more competitive inside and outside the eu; recalls that supplementary protection certificates (spcs) , by extending the patent term up to 5 years , delay access to more affordable generic and biosimilar products thereby placing a major financial burden on national healthcare systems and hampering patients access to treatment; underlines therefore that the use of spcs should be allowed only for exceptional and justified cases;


### 14. stresses the importance of creating quality jobs in the eu along the entire pharmaceutical value chain , with the support of the nextgenerationeu instrument; calls on the commission to propose measures to promote employment in the pharmaceutical sector , facilitating talent retention and mobility at eu level; ### 14. stresses the importance of creating quality jobs in the eu along the entire pharmaceutical value chain , with the support of the nextgenerationeu instrument; calls on the commission to propose measures to promote employment in the pharmaceutical sector , facilitating talent retention and mobility at eu level; recalls that any form of fund or support must be conditioned to clauses on traceability , transparency , accessibility and affordability of manufactured medicines and supply obligations;


### 14. stresses the importance of creating quality jobs in the eu along the entire pharmaceutical value chain , with the support of the nextgenerationeu instrument; calls on the commission to propose measures to promote employment in the pharmaceutical sector , facilitating talent retention and mobility at eu level; ### 14. stresses the importance of creating quality jobs in the eu along the entire pharmaceutical value chain , with the support of the nextgenerationeu instrument; calls on the commission to propose measures to promote employment in the pharmaceutical sector in all member states , ensuring geographical balance and facilitating talent retention and mobility at eu level;


### 15. highlights the fact that gene and cell therapies , personalised medicine , nanotechnology , next-generation vaccines , e-health and the ‘million plus genomes’ initiative can bring enormous benefits in relation to the prevention , diagnosis , treatment and post-treatment of all diseases; urges the commission to develop appropriate regulatory frameworks , to guide new business models , and to run information campaigns to raise awareness and encourage the use of these innovations; ### 15. highlights the fact that gene and cell therapies , personalised medicine , nanomedicines , nanotechnology , next-generation vaccines , e-health and the ‘million plus genomes’ initiative can bring substantial benefits in relation to the prevention , diagnosis , treatment and post-treatment of all diseases if they prove their added value compared to existing health technologies before and after the marketing authorisation phase; highlights as well that the increasing number of advanced medicinal products entering the market with high prices and so far limited information on their added therapeutic value and safety issues poses a great challenge for the sustainability of health budgets and may hamper doctors’ and patients’ ability to choose the adequate treatment; underlines the transformative potential of these novel therapies and technologies for patients as well as societies at large , for example by enabling a shift from chronic management and care to one-time treatment , thereby contributing to reduce costs for health systems , and strengthening their efficacy , sustainability and resilience; urges the commission to develop appropriate regulatory frameworks and to run information campaigns to raise awareness and encourage the use of these innovations when beneficial for patients and once their risk-benefit balance is proved to be positive assessment and improve overall the quality of life of patients; reminds that any decision on the authorization of these innovative products and treatments should be conditioned to the maximum level of patient safety and that fast track approval should be limited to exceptional cases and if needed for urgent public health needs;


### 15. highlights the fact that gene and cell therapies , personalised medicine , nanotechnology , next-generation vaccines , e-health and the ‘million plus genomes’ initiative can bring enormous benefits in relation to the prevention , diagnosis , treatment and post-treatment of all diseases; urges the commission to develop appropriate regulatory frameworks , to guide new business models , and to run information campaigns to raise awareness and encourage the use of these innovations; ### 15. highlights the fact that gene and cell therapies , personalised medicine , nanotechnology , next-generation vaccines , e-health and the ‘million plus genomes’ initiative can bring enormous benefits in relation to the prevention , diagnosis , treatment and post-treatment of all diseases; stresses the transformative potential of these novel therapies and technologies for patients as well as societies at large , for example by enabling a shift from expensive chronic management and care to one-time treatment , thereby reducing costs for health systems , and strengthening their efficacy , sustainability and resilience; urges the commission to ensure sufficient regulatory expertise to support intensive dialogue with developers , and to develop appropriate regulatory frameworks , including for new vaccines and therapeutics for use in emergencies and those addressing unmet medical needs , to guide new business models without compromising/lower standards for safe and efficacious products of consistently high-quality , and to run information campaigns to raise awareness and encourage the use of these innovations;


### 15. highlights the fact that gene and cell therapies , personalised medicine , nanotechnology , next-generation vaccines , e-health and the ‘million plus genomes’ initiative can bring enormous benefits in relation to the prevention , diagnosis , treatment and post-treatment of all diseases; urges the commission to develop appropriate regulatory frameworks , to guide new business models , and to run information campaigns to raise awareness and encourage the use of these innovations; ### 15. highlights the fact that gene and cell therapies , medicine repurposing , personalised medicine , nanotechnology , next-generation vaccines , e-health and the ‘million plus genomes’ initiative can bring enormous benefits in relation to the prevention , diagnosis , treatment and post-treatment of all diseases; urges the commission to develop appropriate regulatory frameworks , to guide new business models , and to run information campaigns to raise awareness and encourage the use of these innovations;


### 16. calls on the commission to fully implement the clinical trials regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products , scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off-patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety , supported by an eu-wide clinical trials network; ### 16. calls on the commission to fully implement the clinical trials regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products , scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off-patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety , supported by an eu-wide clinical trials network; calls on the commission to establish mechanisms for continuous dialogue between the ecdc , ema and vaccines developers on the establishment and functioning of the vaccine platform to monitor vaccine efficacy and safety;


### 16. calls on the commission to fully implement the clinical trials regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products , scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off-patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety , supported by an eu-wide clinical trials network; ### 16. calls on the commission to fully implement the clinical trials regulation9 , actively monitor its implementation on member states level and enforce trial sponsors' compliance with transparency provisions; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products , scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off-patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety , supported by an eu-wide clinical trials network;


### 16. calls on the commission to fully implement the clinical trials regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products , scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off-patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety , supported by an eu-wide clinical trials network; ### 16. calls on the commission to fully implement the clinical trials regulation9 ; welcomes the revision of pharmaceutical legislation to reduce the red tape and adapt it to cutting-edge products , scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off-patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety , supported by an eu-wide clinical trials network;


### 17. urges the commission , based on the experience with the authorisation of covid-19 vaccines , to work with the ema to consider extending the application of rolling reviews to other emergency medicines; further calls on the commission to work with the ema to develop the use of electronic product information for all medicines in the eu; ### 17. urges the commission , based on the experience with the authorisation of covid-19 vaccines , to work with the ema to consider extending the application of rolling reviews to other emergency medicines; further calls for the paper information notice to be supplemented by an electronic product information leaflet notice , to be drawn up in all languages for all the countries where the medicine is marketed in order to facilitate the moving and sales of medicines within the single market and thus mitigate shortages; stresses that electronic product information could complement , but never replace , the package information leaflet;


### 17. urges the commission , based on the experience with the authorisation of covid-19 vaccines , to work with the ema to consider extending the application of rolling reviews to other emergency medicines; further calls on the commission to work with the ema to develop the use of electronic product information for all medicines in the eu; ### 17. urges the commission , based on the experience with the authorisation of covid-19 vaccines , to work with the ema to consider extending the application of rolling reviews to other emergency medicines; further calls on the commission to work with the ema to develop the use of electronic product information for all medicines in the eu in all eu's official languages;


### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; calls on the commission to develop an early warning system for drug shortages , based on a european information network on supply problems , to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; ### 19. 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; considers it imperative to increase the eu’s manufacturing production and ensure sustainable , diversified and robust supply chains; calls on the commission to define a robust supply chain , conduct an assessment of causes and drivers of vulnerabilities and dependencies of the supply chain and of cost implications of increasing the robustness of the supply chains , conduct a mapping of the eu manufacturing capacity , and identify the products critical from the public health view; calls on the commission to develop an early warning system for drug shortages , based on a european information network on supply problems , to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; stresses in this regard the importance of monitoring and fighting against counterfeit pharmaceuticals;


### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; calls on the commission to develop an early warning system for drug shortages , based on a european information network on supply problems , to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; ### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; calls on the commission , member states and the european medicines agency to develop an early warning system for medicine shortages , based on an electronic platform capable of determining the volume of stock existing at any given moment , as well as the actual level of demand , providing data capable of detecting , predicting and preventing shortages of medicinal products; calls also to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies and beyond;


### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; calls on the commission to develop an early warning system for drug shortages , based on a european information network on supply problems , to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; ### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; calls on the commission , the member states and the european medicines agency to develop an electronic platform capable of determining the volume of stock existing at any given moment , as well as the actual level of demand , providing data capable of detecting , predicting and preventing shortages of medicinal products; calls also to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;


### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; calls on the commission to develop an early warning system for drug shortages , based on a european information network on supply problems , to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; ### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; calls on the commission to develop an early warning system for drug shortages , based on a european information network on supply problems , to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; underlines that shortages are a critical public health problem that can seriously harm patients' health and safety , quality of care , professionals' ability to deliver care and health system functioning; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;


### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; calls on the commission to develop an early warning system for drug shortages , based on a european information network on supply problems , to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; ### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; calls on the commission to develop an early warning system for drug shortages , based on a european information network on supply problems , to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines in all member states; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;


### 20. supports the commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain , public authorities , non-governmental patient and health organisations and the research community to address weaknesses in the global medicines manufacturing and supply chain; ### 20. supports the commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain , public authorities , non-governmental patient and health organisations and the research community to address weaknesses in the global medicines manufacturing and supply chain; believes that in addition to the structured dialogue on manufacturing and supply chain , a wider political high level pharmaceutical forum is also needed , including the involvement of policymakers , regulators , payers , industry representatives and patients organizations , among others;


### 20. supports the commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain , public authorities , non-governmental patient and health organisations and the research community to address weaknesses in the global medicines manufacturing and supply chain; ### 20. notes the efforts of the commission to conduct a structured dialogue with players in the pharmaceutical value chain , public authorities , non-governmental patient and health organisations and the research community as one of the tool to explore weaknesses and deficiencies in the global medicines manufacturing and supply chain; calls on the commission to ensure a balanced representation of stakeholders;


### 20. supports the commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain , public authorities , non-governmental patient and health organisations and the research community to address weaknesses in the global medicines manufacturing and supply chain; ### 20. supports the commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain , public authorities , non-governmental patient and health organisations , pharmacists and the research community to address weaknesses in the global medicines manufacturing and supply chain;


### 21. calls on the commission to facilitate agreements between the ema and non-eu regulatory agencies on preventing emergencies and coordinating responses to them; encourages the commission to work with world trade organization members to facilitate trade in health products , increase resilience in global supply chains through stable access to raw materials , and contribute to an effective response in the event of a health emergency; ### 21. calls on the commission to facilitate agreements between the ema and non-eu regulatory agencies on preventing emergencies and coordinating responses to them; encourages the commission to work with world trade organization members to facilitate trade in health products , increase resilience in global supply chains through stable access to raw materials , and contribute to an effective response in the event of a health emergency; calls on the commission to promote the use of trips flexibilities to improve access to medicines and to support that member states can import medicines produced under a compulsory license by reversing their opt-out of article 31bis of the trips agreement;


### 21. calls on the commission to facilitate agreements between the ema and non-eu regulatory agencies on preventing emergencies and coordinating responses to them; encourages the commission to work with world trade organization members to facilitate trade in health products , increase resilience in global supply chains through stable access to raw materials , and contribute to an effective response in the event of a health emergency; ### 21. calls on the commission to facilitate agreements between the ema and non-eu regulatory agencies on preventing emergencies and coordinating responses to them; encourages the commission to work with world trade organization members to facilitate trade in health products , increase resilience in global supply chains through stable access to raw materials , while developing a strategic autonomy in europe for certain essential raw materials , and contribute to an effective response in the event of a health emergency;


### 21. calls on the commission to facilitate agreements between the ema and non-eu regulatory agencies on preventing emergencies and coordinating responses to them; encourages the commission to work with world trade organization members to facilitate trade in health products , increase resilience in global supply chains through stable access to raw materials , and contribute to an effective response in the event of a health emergency; ### 21. calls on the commission to facilitate agreements between the ema and non-eu regulatory agencies on preventing emergencies and coordinating responses to them , in full respect of the highest eu standards for personal data protection; encourages the commission to work with world trade organization members to facilitate trade in health products , increase resilience in global supply chains through stable access to raw materials , and contribute to an effective response in the event of a health emergency;


### 22. stresses the need for the pharmaceutical industry to be environmentally friendly and climate-neutral throughout the life cycles of medicinal products; calls on the commission to strengthen inspection and auditing throughout the production chain; urges the commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-eu countries; calls on the commission to address the problem of domestic pharmaceutical waste , with measures to reduce packaging and the size of containers to ensure they are no larger than necessary , and to bring medical prescriptions into line with real therapeutic needs; ### 22. stresses the need for the pharmaceutical industry to be environmentally friendly and climate-neutral throughout the life cycles of medicinal products; calls on the commission to strengthen inspection and auditing throughout the production chain , particularly outside the union; urges the commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-eu countries; calls on the commission to address the problem of domestic pharmaceutical waste , with measures to reduce packaging and the size of containers to ensure they are no larger than necessary , and to bring medical prescriptions into line with real therapeutic needs; notes that that eproduct information should be available as a complementary tool to the paper version;


### 23. calls on the commission to further facilitate access to global markets for the eu pharmaceutical industry , including small and medium-sized enterprises , through a level playing field and a regulatory framework facilitating trade agreements that prize innovation-based competitiveness , in order to make the pharmaceutical sector a strategic pillar of the eu; ### 23. calls on the commission to further facilitate access to global markets for the eu pharmaceutical industry , including small and medium-sized enterprises , through a level playing field and a regulatory framework facilitating trade agreements that prize innovation-based competitiveness , in order to make the pharmaceutical sector a strategic pillar of the eu; calls on the commission to ensure that trade agreements contribute to improved access to safe , affective and affordable medicines in the eu and in third countries.


### 24. reiterates its commitment to continue working with the commission and the world health organization to standardise effective , safe and sustainable regulatory frameworks for medicinal products; ### 24. reiterates its commitment to continue working with the commission and the world health organization to improve access to safe , effective and affordable medicines;


### 3. notes that in 2020 , the eea's total budget was eur 63 229 066 (a 21 ,5% increase on 2019 although still below the 2018 figure) , of which eur 41 972 000 (representing an increase of 5 ,6 % compared to 2019) came from the general budget of the union; notes that the eea is expected to play a key role (monitoring , reporting and validating) in supporting the european green deal actions and the 8th general union environment action programme1 ; insists therefore that the staff budget for the eea should be increased to meet these obligations; notes that any future cuts will negatively impact the functioning of the eea and the delivery of the european green deal; ### 3. notes that in 2020 , the eea's total budget was eur 63 229 066 (a 21 ,5% increase on 2019 although still below the 2018 figure) , of which eur 41 972 000 (representing an increase of 5 ,6 % compared to 2019) came from the general budget of the union; notes that the eea is expected to play a key role (monitoring , reporting and validating) in supporting the european green deal actions and the 8th general union environment action programme1 ; insists therefore that the staff budget for the eea should be increased to meet these obligations; notes that any future cuts will negatively impact the functioning of the eea and the delivery of the european green deal; recalls that policymakers rely on the expertise and support of the eea in facilitating the reforms required to achieve a climate neutral future; stresses that inadequate resources for the eea may undermine the ability of the institutions to deliver on commitments in relation to the european green deal;


### 5. stresses the need to ensure that the agency is able to fulfil its mandate in the long term; calls , in this regard , for the lack of predictability of the agency’s budget income to be addressed; notes the declining trend in fee income and believes that a new stable financing model should be developed and introduced without unnecessary delays; ### 5. stresses the need to ensure that the agency is able to fulfil its mandate in the long term; calls , in this regard , for the lack of predictability of the agency’s budget income to be addressed; while recognizing the positive developments in the governance and financing structure of the agency , notes the declining trend in fee income and believes that a new stable financing model should be developed and introduced without unnecessary delays; highlights that despite previously declared observations from the parliament and the court of auditors , an unforeseen and significant drop of eur 7 ,0 million in fee income under the reach regulation was reported by the agency in 2020;


### 6. underlines the necessity of ensuring adequate staffing reflecting the needs of the european green deal and the union chemical strategy for sustainability , circular economy action plan and zero pollution ambition in particular; ### 6. underlines the necessity of ensuring adequate staffing reflecting the needs of the european green deal and the union chemical strategy for sustainability , circular economy action plan and zero pollution ambition in particular; notes the positive work undertaken on directive 2008/98/ec of the european parliament and of the council1a and recognises the need for continued efforts towards establishing a fully sustainable financing model;


### (2) the unprecedented experience of the covid-19 pandemic has demonstrated that the union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health. the union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic , and also by the limited degree of union preparedness in case of a public health emergency impacting a majority of member states. ### (2) the unprecedented experience of the covid-19 pandemic has demonstrated that the union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health , but it has also demonstrated the need for closer cooperation and faster exchanges of information between members states and the european institutions on the measures implemented. the union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic , and also by the limited degree of union preparedness in case of a public health emergency impacting a majority of member states.


### (2) the unprecedented experience of the covid-19 pandemic has demonstrated that the union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health. the union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic , and also by the limited degree of union preparedness in case of a public health emergency impacting a majority of member states. ### (2) the unprecedented experience of the covid-19 pandemic has demonstrated that the union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health. the union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic , and also by the limited degree of union preparedness in case of a public health emergency impacting a majority of member states. the pandemic has also shown the necessity of having an innovative and research based pharmaceutical industry that works closely with ema in order to be better prepared for future health crisis and disruptions in the supply chain. covid-19 also underlined the need for more transparency on medicines pricing and eu marketing authorisation.


### (6) the rapid evolution of covid-19 and the spread of the virus led to a sharp increase in demand for medical devices such as ventilators , surgical masks , and covid-19 test kits while disruption of production or limited capacity to rapidly increase production and the complexity and global nature of the supply chain for medical devices , led to a negative impact on supply. those issues resulted in new entities being involved in the production of those products , which subsequently resulted in bottlenecks in conformity assessment , as well as the prevalence of non-compliant , unsafe , and in some cases counterfeit products. it is therefore appropriate to establish long-term structures within an appropriate union body to ensure monitoring of shortages of medical devices resulting from a public health emergency. ### (6) the rapid evolution of covid-19 and the spread of the virus led to a sharp increase in demand for medical devices such as ventilators , surgical masks , and covid-19 test kits while disruption of production or limited capacity to rapidly increase production and the complexity and global nature of the supply chain for medical devices , led to a negative impact on supply. those issues resulted in new entities being involved in the production of those products , which subsequently resulted in bottlenecks in conformity assessment , as well as the prevalence of non-compliant , unsafe , and in some cases counterfeit products. it is therefore appropriate to establish long-term structures within an appropriate union body that will ensure monitoring of shortages of medical devices resulting from a public health emergency and to propose measures that can be agreed and implemented jointly across europe.


### (8) safe and efficacious medicinal products that treat , prevent or diagnose diseases which cause public health emergencies , should be developed and made available within the union as soon as possible during such emergencies. the covid-19 pandemic has also highlighted sub-optimal coordination and decision-making as regards multinational clinical trials , and union-level advice on the use of medicinal products in national compassionate use programmes or outside of their authorised indications in the union , causing delays in the adoption of research outcomes and in the development and availability of new or repurposed medicines. ### (8) safe and efficacious medicinal products that treat , prevent or diagnose diseases which cause public health emergencies , should be developed , if necessary through joint undertakings by public authorities , the private sector and academia , and made available within the union as soon as possible during such emergencies. the covid-19 pandemic has also highlighted sub-optimal coordination and decision-making as regards multinational clinical trials , and union-level advice on the use of medicinal products in national compassionate use programmes or outside of their authorised indications in the union , causing delays in the adoption of research outcomes and in the development and availability of new or repurposed medicines.


### (9) during the covid-19 pandemic ad hoc solutions , including contingent arrangements between the commission , the european medicines agency (‘the agency’) , marketing authorisation holders , manufacturers and member states , had to be found to achieve the objective of making available safe and efficacious medicinal products to treat covid-19 or prevent its spread , and to facilitate and speed up the development and marketing authorisation of treatments and vaccines. ### (9) during the covid-19 pandemic ad hoc solutions , including contingent arrangements between the commission , the european medicines agency (‘the agency’) , marketing authorisation holders , manufacturers and member states , had to be found to achieve the objective of making available to the member states safe and efficacious medicinal products to treat covid-19 or prevent its spread , and to facilitate and speed up the development and marketing authorisation of treatments and vaccines.


### (10) in order to ensure a better functioning of the internal market of those products and contribute to a high level of human health protection , it is therefore appropriate to approximate the rules on monitoring of shortages of medicinal products and medical devices , and to facilitate the research and development of medicinal products , which may have the potential to treat , prevent , or diagnose diseases that cause public health crises. ### (10) in order to ensure a better functioning of the internal market of those products and contribute to a high level of human health protection , it is therefore appropriate to approximate the rules on monitoring of shortages of medicinal products and medical devices , and to facilitate the research and development of medicinal products , which may have the potential to treat , prevent , or diagnose diseases that cause public health crises. highlights in this respect the necessity of developing analytics to predict emerging risks , including the use of alternative data sources.


### (17) in order to ensure that safe , high quality , and efficacious medicinal products , which have the potential to address public health emergencies , can be developed and made available within the union as soon as possible during public health emergencies , an emergency task force should be established within the agency to provide advice on such medicinal products. the emergency task force should provide advice free of charge on scientific questions related to the development of treatments and vaccines and on clinical trial protocols , to those organisations involved in their development , such as marketing authorisation holders , clinical trial sponsors , public health bodies , and academia , irrespective of their exact role in the development of such medicinal products. ### (17) in order to ensure that safe , high quality , and efficacious medicinal products , which have the potential to address public health emergencies , can be developed and made available within the union as soon as possible during public health emergencies , an emergency task force should be established within the agency to provide advice on such medicinal products. the emergency task force should provide advice free of charge on scientific questions related to the development of treatments and vaccines and on clinical trial protocols , as well as existing minimum stock levels needed to manage the crisis adequately , to those organisations involved in their development , such as marketing authorisation holders , clinical trial sponsors , public health bodies , and academia , irrespective of their exact role in the development of such medicinal products.