What changed between the plenary report and the adopted text

Added:(57) The issuing of documentation fromapplication for pricing and reimbursement in the Member States as regards the prolongation of data protection for the purpose of supply of medicinal products in all Member States where a marketing authorisation is valid, in particular the waiver to the conditions for such prolongation, does not affect at any time the powers of the Member States as regards the supply, setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes. Member States do not waive the possibility to request release or supply of the product concerned at any time before, during or after the prolongation of the data protection period. [Am. 41]

Removed:Article 1 – paragraph 5 – point b: (b) medicinal product prepared in a pharmacy in accordance with a pharmacopoeia and intended to be supplied directly to the patients served by the pharmacy in question or to another pharmacy which intends to supply the medicinal product directly to the patient (‘officinal formula’);

Added:(58) An alternative way of demonstrating supply relates to the inclusion of medicinal products in a positive list of medicinal products covered by the national health insurance system in accordance with Council Directive 89/105/EEC. The related negotiations between companies and the Member State should be conducted in good faith, and all parties should adhere to the deadlines set out in Directive 89/105/EEC. [Am. 42]

Removed:Article 1 – paragraph 5 – point c a (new): (ca) medicinal product prepared in advance, in duly justified cases, by the pharmaceutical department of a hospital (‘hospital formula’), supplied on medical prescription to one or several patients by the hospital’s pharmaceutical department.

Added:(58a) Cross-border healthcare is an important pathway for patients to access medicinal products that might otherwise not be available to them. To support access to medicinal products, in particular in the case of small patient populations, such as for paediatric or rare diseases, which are often disadvantaged when it comes to access to medicinal products, or where the administration of a medicinal product requires special competences or infrastructure, the full implementation of Directive 2011/24/EU of the European Parliament and of the Council should be supported. It is important to consider in that regard all alternative paths to making available medicinal products to patients. Competent authorities of the Member States should therefore utilise the NCAPR to exchange and share best practice regarding the implementation of cross-border access agreements and negotiations. [Am. 43]

Removed:Article 1 – paragraph 6: 6. Medicinal products referred to in paragraph 5, points (a) and (b), may be prepared in duly justified cases in advance by a pharmacy serving a hospital, on the basis of the estimated medical prescriptions within that hospital for the following seven days, or when duly justified based on the stability of the medicinal product within a different time limit.

Added:(59) A Member State that considers that the conditions of supply have not been met for its territory should provide a reasoned statement of non-compliance at the latest in the Standing Committee on Medicinal Products for Human Use procedure of the variation linked to the provision of the relevant incentive. [Am. 44]

Removed:Article 1 – paragraph 7: 7. Member States shall take the necessary measures to develop the production and use of medicinal products derived from substances of human origin coming from voluntary unpaid donations in accordance with Regulation (EU) 2024/... [SoHO Regulation].

Added:(60) The Commission and Member States shall continuously monitor any data and learnings from the application of the incentives system in order to improve, including through implementing acts, how these provisions are applied. The Commission shall establish a list of national contact points in this regard.

Removed:Article 1 – paragraph 10 – point a: deleted

Added:(61) When a compulsory licence has been granted under conditions laid down in Union law and in compliance with international agreements by a relevant authority in the Union to tackle a public health emergency, regulatory data protection may, if still in force, prevent the effective use of the compulsory licence as they impede the authorisation of generic medicinal products, and thus access to the medicinal products needed to address the crisis. For this reason, data and market protection should be suspended when a compulsory licence has been issued to tackle a public health emergency. Such a suspension of the regulatory data protection should be allowed only in relation to the compulsory licence granted and its beneficiary. The suspension shall comply with the objective, the territorial scope, the duration and the subject matter of the granted compulsory licence. [Am. 45]

Removed:Article 2 – paragraph 1: 1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared a non-routine basis in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner and, where relevant, a hospital pharmacist. To satisfy the criteria of 'non-routine basis', the exemption shall be made only in order to comply with an individual medical prescription for a custom-made product to meet the special need of an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’).

Added:(62) The suspension of the regulatory data protection should be granted only for the duration of the compulsory licence in the Member States where the compulsory licence has been granted. A ‘suspension‘ of data and market protection in cases of public health emergencyaccordance with a compulsory licence granted by a relevant authority in the Union under conditions laid down in Union law and in compliance with international agreements shall mean that data and market protection shall produce no effect in relation to the particular licensee of the compulsory licence while that compulsory licence is in effect. When the compulsory licence ends, the data and market protection shall resume their effect. The suspension should not result in an extension of the original duration. [Am. 46]

Removed:Article 2 – paragraph 2 – subparagraph 2: The application for a hospital exemption approval shall be submitted to the competent authority of the Member State where the hospital is located. The application shall include evidence on quality, safety and expected efficacy of the advanced therapy medicinal products prepared under hospital exemption.

Added:(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being considered patent or SPC infringement. The application of this limited exemption is however fragmented across the Union and it is considered necessary, in order to facilitate the market entry of generic, biosimilar, hybrid and bio-hybrid medicinal products that rely on a reference medicinal product, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conduct studies and trials and other activities needed for the regulatory approval process, health technology assessment and pricing reimbursement request, even though this may require substantial amounts of test production to demonstrate reliable manufacturing. During the term of protection of the patent or SPC of the reference medicinal product, there can be no commercial use of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

Removed:Article 2 – paragraph 3: 3. Member States shall ensure that advanced therapy medicinal products prepared under hospital exemption comply with the good pharmacy preparation practices that are adapted to hospital processes while still equivalent to the good manufacturing practices and traceability for advanced therapy medicinal products referred to in Articles 5 and 15 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council69 respectively, and with pharmacovigilance requirements equivalent to those provided for at Union level pursuant to [revised Regulation (EC) No 726/2004]. This shall include site inspections as well as traceability and pharmacovigilance plans and the evaluation of the preclinical and clinical data generated by the applicant.

Added:(64) It will allow all necessary steps to support timely access to generic medicinal products, inter alia, to conduct studies to support pricing and reimbursement as well as the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that period, contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars on day one of loss of the patent or SPC protection. [Am. 47]

Removed:Article 2 – paragraph 4: 4. Member States shall ensure that data on the use, safety and the efficacy of advanced therapy medicinal products prepared under hospital exemption, as well as any relevant data from patient follow-up for a sufficient period of time after the administration of the advanced therapy medicinal product, is collected and reported by the hospital exemption approval holder to the competent authority of the Member State at least annually. The data shall be collected and reported in a structured and standardised way that enables robust, reliable and comparable results and conclusions. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3. Competent authorities shall ensure that scientific and regulatory advice is provided to non-profit and academic institutions in order to ensure appropriate reporting mechanisms.

Added:(65) The timely availability of generic and biosimilar medicinal products were highlighted as priorities in the conclusions of the Council on strengthening the balance in the pharmaceutical systems in the European Union and its Member States, in the conclusions of the Council on Access to medicines and medical devices for a Stronger and Resilient EU and in the resolution of the European Parliament of 2 March 2017 on EU options for improving access to medicines.The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product only on the basis of the grounds set out in this Directive. The same applies to any decision to grant, vary, suspend, restrict or revoke the marketing authorisation. The competent authorities cannot base their decision on any other grounds. In particular, those decisions cannot be based on the patent or SPC status of the reference medicinal product. It is therefore appropriate to explicitly prohibit that practice. [Am. 48]

Removed:Article 2 – paragraph 6: 6. The competent authority of the Member State shall transmit the data related to the use, safety and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain via regular updates a repository of that data as well as of information on the authorisation, suspension or withdrawal of hospital exemption approvals, which shall be updated regularly. The repository shall be publicly available except for personal data and commercially confidentail information.

Added:(65a) The One Health Approach is needed in order to address antimicrobial resistance, one of the most significant, current health threats. It is estimated that more than 35 000 people in the Union/European Economic Area and more than 1,2 million people globally die each year as a direct consequence of an infection due to bacteria resistant to antibiotics. High levels of cooperation are required across sectors and globally. This Directive puts in place coordinated action in order to ensure prevention and minimisation of environmental risks throughout the supply chain, use and disposal, awareness raising among patients, consumers and healthcare professionals and prudent and responsible use of antimicrobials. [Am. 49]

Removed:Article 2 – paragraph 7 – subparagraph 1 – point a: deleted

Added:(66) In order to address the challenge of antimicrobial resistance, antimicrobials should be packaged in quantities that are appropriate for the therapy cycle relevant for that product, including where possible the per unit dispensing, and national rules on antimicrobial subject to prescription ensure that they are dispensed in a way that corresponds to the quantities described by the prescription. Dispensing the exact number of units needed could help address antimicrobial resistance as well as environmental impact. [Am. 50]

Removed:Article 2 – paragraph 7 – subparagraph 1 – point c a (new): (ca) the modalities of guidance for academic and other not-for-profit entities through the requirements of the hospital exemption clause.

Added:(67) The provision of information to healthcare professionals and to patients on the appropriate use, storage and disposal of antimicrobials is a joint responsibility of marketing authorisation holders and of Member States. Member States who should ensure appropriate collection and disposal system for all medicinal products. [Am. 51]

Removed:Article 2 – paragraph 7 – subparagraph 1 – point d: deleted

Added:(67a) Pharmacists and other health care professionals should play a role in antimicrobial stewardship, including advising on the prudent use of antibiotics and other antimicrobials, as well as their correct disposal. [Am. 52]

Removed:Article 2 – paragraph 7 – subparagraph 2 a (new): By ... [24 months from the date of entry into force of this Directive], the Commission shall adopt delegated acts in accordance with Article 215 to supplement this Directive by establishing: / (a) details of the application for the approval of hospital exemption referred to in paragraph 1, second subparagraph, including the evidence on quality, safety and efficacy of the advance therapy medicinal products prepared under hospital exemption for the approval and the subsequent changes; / (b) the modalities for harmonised implementation of the preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis.

Added:(68) While this Directive restricts the use of antimicrobials by setting certain categories ofantibiotics and antimicrobials which have an identified risk of resistance under prescription status, due to the growing antimicrobial resistance in the Union, competent authorities of the Member States should consider further a number of measures for example, including expanding the prescription status of antimicrobials, restricting the use of certain antimicrobials to the use in hospitals, mandatory training of healthcare professionals on the environmental impact of medicines use and stewardship regarding the use of antimicrobials, or the mandatory use of diagnostic tests before prescription. Member States should also ensure that measures are in place to safeguard the prescription for antibiotic products from influence by any form of economic incentive provided directly or indirectly to persons who prescribe medicinal products, given the risks associated with antimicrobial resistance and for avoiding risks to the environment, in line with the European Union Strategic Approach to Pharmaceuticals in the Environment. Additionally, the combined use of several antimicrobial active substances may represent a particular risk with respect to the development of antimicrobial resistance. Such combined use should therefore only be prescribed in exceptional cases where the benefit-risk balance of the combination is favourable. Competent authorities of the Member States should promote the availability of rapid diagnostic tests in the Member States and should consider such further measures according to the level of antimicrobial resistance in their territory and the needs of patients. [Am. 53]

Removed:Article 2 – paragraph 8: 8. The Agency shall provide to the Commission a report on the experience acquired with the hospital exemption approvals on the basis of contributions from Member States and the data referred to in paragraph 4. The report shall be made publicly available. The first report shall be provided three years after [OP please insert the date =18 months after the date of entering into force of this Directive] and then every five years thereafter.

Added:(69) The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem, and there is scientific evidence that the presence of those substances in the environment from their manufacturing, use and disposal poses a risk to the environment and public health. The evaluation of the legislation showed that strengthening of existing measures to reduce the impact of medicinal products' lifecycle on the environment and public health is required. Measures under this RegulationDirective complement the main environmental legislation, in particular the Water Framework Directive (2000/60/EC), the Environmental Quality Standard Directive (2008/105/EC) the Groundwater Directive (2006/118/EC), the Urban Wastewater Treatment Directive (91/271/EEC), the Drinking Water Directive (2020/2184) and, the Industrial Emissions Directive (2010/75/EU) and the Waste Framework Directive (2008/98/EC). [Am. 54]

Removed:Article 2 – paragraph 8 a (new): 8a. By way of derogation from paragraph 1, Member States may authorise the cross-border exchange of advanced therapy medicinal products prepared under hospital exemption in justified cases of medical need and in the absence of other solutions for the individual patient. A second medical practitioner and a hospital pharmacist in the receiving Member State shall be designated for the exclusive professional responsibility of the use and collection of follow-up data for the advanced therapy medicinal product. Information about the cross-border exchange shall be submitted to the competent authorities of both Member States, and shall be shared in the public repository referred to in paragraph 6 by the competent authority of the Member State of origin of the advanced therapy medicinal product.

Added:(69a) Emissions of active substances during manufacturing can be a threat to the environment and public health. Therefore, environmental risks should be assessed and addressed through the entire lifecycle of medicinal products, starting from manufacturing, through use and to disposal. [Am. 55]

Removed:Article 3 – paragraph 1 – subparagraph 1: A Member State may, in order to fulfil special needs, exclude from the scope of this Directive medicinal products supplied in response to a bona fide unsolicited order, prepared in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under their direct personal responsibility, or prepared in accordance with the specifications of a competent authority. However, in such case Member States shall encourage and establish channels for healthcare professionals and patients to report data on the safety of the use of such products to the competent authority of the Member State in accordance with Article 97.

Added:(69b) Unitary packaging of medicinal products, in particular in hospital pharmacies, where such products are packaged and distributed in bulk, could result in a decrease of packaging materials used and thereby contribute to environmental footprint of medicinal products, including its waste. It can also contribute to mitigating medicine shortages and antimicrobial resistance. The use of single dose unit containing all relevant information, in hospital environment, could furthermore represent an improvement in the risk of medication errors and therefore increase patient protection. Member States should promote the use of unit dose pre-cut blisters in hospital environment and, progressively, in dispensing pharmacies, when necessary. [Am. 56]

Removed:Article 4 – paragraph 1 – point 11: (11) ‘non-clinical’ means a study or a test conducted in vitro, ex vivo, in silico, or in chemico, or a non-human in vivo test related to the investigation of the safety and efficacy of a medicinal product. Such test may include simple and complex human cell-based assays, microphysiological systems including organ-on-chip, computer modelling and other in silico methods, other non-human or human biology-based test methods, including aquatic egg models as well as invertebrate species, and animal-based tests;

Added:(69c) The use of pharmaceuticals in human and veterinary medicinal products, including antimicrobials, has increased their concentrations in many environmental reservoirs such as soils, sediments and waterbodies in the past 20 years, and the environmental concentration is likely to increase further as the population grows and ages. The discharge of pharmaceuticals into the environment can not only harm ecosystems and wildlife, but can also undermine the effectiveness of those same pharmaceuticals. The chemical and metabolic stability of certain pharmaceuticals means that up to 90 % of their active substances are released into the environment in their original form after use. [Am. 57]

Removed:Article 4 – paragraph 1 – point 22: (22) ‘antimicrobial’ means any medicinal product with a direct action on micro-organisms used for treatment or prevention of infections or infectious diseases, including antibiotics, antivirals, antifungals and antiprotozoals;

Added:(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation should be refused. The ERA should be updated when new data or knowledge about relevant risks become available.

Removed:Article 4 – paragraph 1 – point 26: (26) ‘combination of a medicinal product with a product other than a medical device’ means a combination of a medicinal product with a product other than a medical device (as defined by Regulation (EU) 2017/745 and Regulation (EU) 2017/746 of the European Parliament and of the Council1a) and where the two are intended for use in the given combination in accordance with the summary of product characteristics; / 1a Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117 5.5.2017, p. 176).

Added:(70a) In exceptional cases where the ERA is incomplete due to missing data and this can be duly justified and substantiated by the marketing authorisation holder, it should still be possible, for reasons in the interest of public health, for the medicinal product to be placed on the market with certain post-authorisation conditions and obligations. Where a medicinal product has been authorised and the ERA is incomplete due to missing data, the marketing authorisation holder should submit the completed ERA in the timeline agreed with the authorities and deliver upon any other post-authorisation obligations. [Am. 58]

Removed:Article 4 – paragraph 1 – point 29 – introductory part: (29) “gene therapy medicinal product” means a type 1 or type 2 medicinal product; / (deleted) / (deleted)

Added:(71) Marketing authorisation applicants should take into account environmental risk assessment procedures of other EU legal frameworks that may apply to chemicals dependent on their use. Further to this Regulation, there are four main other frameworks: (i) Industrial chemicals (REACH, (Regulation (EC) No 1907/2006); (ii) Biocides (Regulation (EC) No 528/2012); (iii) Pesticides (Regulation (EC) No 1107/2009); and (iv) Veterinary medicines (Regulation (EU) 2019/6)). As a part of the Green Deal, the Commission has proposed a ‘one-substance one-assessment’ (OS-OA) approach for chemicals, in order to increase the efficiency of the registration system, reduce costs and unnecessary animal testing. The ERA covers the risks associated with production. Compliance with relevant Union and Member State legislation in terms of environmental protection at the stage of manufacturing should generally be considered as a relevant risk mitigation measure in terms of production. This should also apply for production in third countries with a level of environmental protection equivalent to that of the Union. More environmentally friendly pharmaceuticals would contribute positively to human health. [Am. 59]

Removed:Article 4 – paragraph 1 – point 29 a (new): (29a) “type 1 gene therapy medicinal product” means a medicinal product that contains or consists of a substance or a combination of substances that edit the host genome in a sequence-specific manner or that contain or consists of cells subjected to such modification;

Added:(72) The emissions and discharges of antimicrobials to the environment from manufacturing sites may lead to antimicrobial resistance (“AMR”), which is a global concern regardless where the emissions and discharges take place. Therefore, the ERA scope should be extended to cover the risk of AMR selection during the entire life cycle of antimicrobials, including manufacturing. At the date of adoption of this Directive, for the purpose of the ERA, there is not a scientifically agreed method to measure antimicrobial resistance other than for antibiotic resistance. The Commission should therefore issue, after consulting the European Medicines Agency (EMA), the European Centre for Disease Prevention and Control (ECDC) and the European Environment Agency (EEA), guidelines on how to conduct ERAs for AMR selection for microbials other than bacteria. [Am. 60]

Removed:Article 4 – paragraph 1 – point 29 b (new): (29b) “type 2 gene therapy medicinal product” means a medicinal product, except a vaccine against infectious disease that contains or consists of a recombinant or synthetic nucleic acid used in or administered to human beings with a view to regulating, replacing or adding a genetic sequence that mediates its effect by transcription or translation of the transferred genetic materials or that contain or consists of cells subjected to these modifications;

Added:(73) The proposal also includes provisions for a risk-based approach regarding the ERA obligations of marketing authorisation holders before October 2005 and the setting-up of an ERA monograph system for active substances. This ERA monograph system should be available to applicants for use when conducting an ERA for a new application.

Removed:Article 4 – paragraph 1 – point 30 a (new): (30a) ‘platform technology’ means a technology or collection of technologies that is comprehensive, well-characterised, reproducible and used to support the development, manufacturing process, quality control, or testing of medicinal products or their components that rely on prior knowledge and are established under the same underlying scientific principles

Added:(74) For medicinal products authorised prior to October 2005, without any ERA, specific provisions should be introduced to set up a risk based prioritisation programme for the ERA submission or update by the market authorisation holders.

Removed:Article 4 – paragraph 1 – point 30 b (new): (30b) ‘platform technology master file’ means a document, prepared by the owner of the platform technology, that contains data of a platform technology for which the underlying scientific principles, under which the platform technology is established, have reasonable scientific certainty to remain unchanged across medicinal products and to apply regardless of components added to the platform for a medicinal product;

Added:(74a) According to the Aarhus Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters, the public has a right to obtain information on environmental matters, including on the ERA of a pharmaceutical product. [Am. 61]

Removed:Article 4 – paragraph 1 – point 31 – point a: (a) a method involving an industrial process which includes pooling of donations, for purposes beyond processing of substances of human origin for concentrates or pathogen inactivation; or

Added:(75) Cyprus, Ireland, Malta and Northern Ireland have historically relied on the supply of medicinal products from or through parts of the United Kingdom other than Northern Ireland. Following the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, to prevent shortages of medicinal products and ultimately to ensure a high level of public health protection, specific derogations to this Directive need to be included for medicinal products supplied to Cyprus, Ireland, Malta and Northern Ireland from or through parts of the United Kingdom other than Northern Ireland. In order to ensure uniform application of Union law in the Member States, the derogations applicable in Cyprus, Ireland and Malta should be of a temporary nature only.

Removed:Article 4 – paragraph 1 – point 33: (33) ‘environmental risk assessment’ means the evaluation of the risks to the environment, or risks to public health, posed by the release of the medicinal product in the environment from the manufacturing, use and disposal of the medicinal product and the identification of risk prevention, limitation and mitigation measures. For medicinal product with an antimicrobial mode of action, the ERA also encompasses an evaluation of the risk for antimicrobial resistance selection in the environment due to the manufacturing, use and disposal of that medicinal product;

Added:(76) To ensure that all children in the Union have access to the products specifically authorised for paediatric use, when an agreed paediatric investigation plan has led to the authorisation of a paediatric indication for a product already marketed for other therapeutic indications, the marketing authorisation holder should be obliged to place the product in the same markets within two years of the date of approval of the indication.

Removed:Article 4 – paragraph 1 – point 34: (34) ‘antimicrobial resistance’ means the ability of a micro-organism to survive or to grow in the presence of a concentration of an antimicrobial agent that is usually or was previously sufficient to inhibit or kill that micro-organism;

Added:(77) It is necessary in the interest of public health to ensure the continuing availability of safe and effective medicinal products authorised for paediatric indications. Therefore, if a marketing authorisation holder intends to withdraw such a medicinal product from the market then arrangements should be in place so that the paediatric population can continue to have access to the medicinal product in question. In order to help achieve this, the Agency should be informed in good time of any such intention and should make that intention publicly available.

Removed:Article 4 – paragraph 1 – point 62: (62) ‘homeopathic product’ means a medicinal product prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States;

Added:(78) To avoid unnecessary administrative and financial burdens both for the marketing authorisation holders and the competent authorities, certain streamlining measures should be introduced, in line with the digital by default principle. Electronic application for marketing authorisation and for variations to the terms of the marketing authorisation should be introduced.

Removed:Article 4 – paragraph 1 – point 70: (70) ‘public service obligation’ means to ensure permanently an adequate range of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a very short time over the whole of the area in question.