identifier: ETS No. 193

openingPlace: Chisinau

reference: ETS No. 193

title: European Convention for the Protection of Animals during International Transport (Revised)

text: European Treaty Series - No. 193

text: European Convention for the Protection of Animals during International

text: Transport (Revised)

text: Chişinau, 6.XI.2003

text: The member States of the Council of Europe, signatory hereto,

text: Considering that the aim of the Council of Europe is to achieve a greater unity between its members for the purpose of safeguarding and realising the ideals and principles which are their common heritage;

text: Aware that every person has a moral obligation to respect all animals and to have due consideration for their capacity for suffering;

text: Motivated by the desire to safeguard the welfare of animals during transport;

text: Convinced that international transport is compatible with the welfare of the animals, provided that the requirements of animal welfare are met;

text: Considering, therefore, that where the welfare requirements of the animals cannot be met an alternative to the transport of live animals shall be implemented;

text: Considering, however, that in general, for reasons of animal welfare the period during which animals, including animals for slaughter, are transported should be reduced as far as possible;

text: Considering that loading and unloading are activities during which injuries and stress are most likely to occur;

text: Considering that progress in this respect may be achieved through the adoption of common provisions regarding the international transport of animals,

text: Have agreed as follows:

text: _____ (*) The Treaty of Lisbon amending the Treaty on European Union and the Treaty establishing the European Community entered into force on 1 December 2009. As a consequence, as from that date, any reference to the European Economic Community shall be read as the European Union.

text: ETS 193 – Protection of Animals during International Transport (Revised), 6.XI.2003 __________________________________________________________________________________

text: General principles

text: "International transport" means any movement from one country to another, but excludes, however, journeys of less than 50 km and movements between member States of the European Community. 2 An "authorised veterinarian" means a veterinarian nominated by the competent authority. 3 "Person responsible for the transport of the animals" means the person with overall control over the organisation, carrying out and completion of the whole journey, regardless of whether duties are subcontracted to other parties during transport. Such a person is usually the person who plans, makes arrangements for and defines the conditions to be met by other parties. 4 "Person in charge of the welfare of the animals" means the person who has direct physical responsibility for the care of the animals during transport. Such a person may be the attendant or the driver of a vehicle if fulfilling the same role. 5 "Container" means any crate, box, receptacle or other rigid container used for the transport of animals which is not self-propelled and is not a part (whether detachable or not) of a means of transport. 6 "Transporter" means a natural or legal person transporting animals, either on his own account or for a third party.

text: Article 1 – Definitions

text: This Convention applies to the international transport of all vertebrate animals. 2 With the exception of

text: Article 4

text: , paragraph 1, and

text: Article 9

text: , paragraphs 1 and 2 a and c, the provisions of this Convention do not apply: a where a single animal is accompanied by the person who is responsible for it during transport; b to the transport of pet animals accompanying their owner if not for commercial purposes.

text: Article 2 – Species

text: Each Party shall apply the provisions governing the international transport of animals contained in this Convention and be responsible for effective control and supervision. 2 Each Party shall take the necessary steps to ensure an effective system of training taking into account the provisions of the present Convention. 3 Each Party shall endeavour to apply the relevant provisions in this Convention to animals being transported within its territory. 4 The Parties shall provide mutual assistance in applying the provisions of the Convention, in particular by exchanging information, discussing interpretation and notifying problems.

text: Article 3 – Application of the Convention

text: Animals shall be transported in a way which safeguards their welfare, including health.

text: As far as possible, animals shall be transported without delay to their place of destination.

text: At control points, priority shall be given to consignments of animals.

text: Animals shall only be detained where this is strictly necessary for their welfare or for disease control purposes. If animals are detained, appropriate arrangements shall be made for their care and, where necessary, their unloading and accommodation.

text: Each Party shall take the necessary measures to avoid or reduce to a minimum the suffering of animals in cases where strikes or other unforeseeable circumstances impede the strict application of the provisions of this Convention in its territory. It will be guided for this purpose by the principles set out in this Convention.

text: Nothing in this Convention shall affect the implementation of other instruments concerning sanitary and veterinary control.

text: Nothing in this Convention shall affect the liberty of the Parties to adopt stricter measures for the protection of animals during international transport.

text: Article 4 – Main principles of the Convention

text: registered in a manner enabling the competent authority to identify them rapidly in the event of failure to comply with the requirements of this Convention;

text: covered by an authorisation valid for international transport granted by the competent authority of the Party in which the transporters are established.

text: Each Party shall ensure that transporters transporting animals for commercial purposes are:

text: Each Party shall ensure that the authorisation is granted to transporters who entrust the transport of animals only to personnel who have received proper training on the provisions of this Convention.

text: Each Party shall ensure that the above-mentioned authorisation may be suspended or withdrawn where the competent authorities that granted the authorisation are informed that the transporter has repeatedly or seriously violated the provisions of this Convention.

text: Where a Party has observed an infringement of this Convention by a transporter registered in another Party to this Convention, the former Party shall communicate details of the infringement observed to the latter.

text: Design and construction

text: Article 5 – Authorisation of transporters

text: Means of transport, containers and their fittings shall be constructed, maintained and operated so as to avoid injury and suffering and to ensure the safety of the animals during transport.

text: The means of transport or container shall be designed and constructed so as to provide animals with adequate space to stand in their natural position, except for poultry other than day-old chicks.

text: sufficient clear space above the animals in their natural standing position for effective air circulation;

text: air quality and quantity appropriate to the species transported can be maintained, in particular where animals are carried in a fully enclosed space.

text: The means of transport or container shall be designed and constructed so as to ensure:

text: Means of transport, containers, fittings, etc., shall be strong enough to contain the animals' weight, to prevent them escaping or falling out, to withstand stress due to movement and, where necessary, to contain partitions to protect animals from the motion of the means of transport. Fittings shall be designed for quick and easy operation.

text: Partitions shall be of rigid construction, strong enough to withstand the weight of animals being pushed against them and designed so that they do not impede air circulation.

text: The means of transport or containers shall be constructed and operated so as to protect animals against inclement weather and adverse changes in weather conditions. In particular, the external roof directly above the animals shall minimise absorption and conduction of solar heat.

text: The floor of the means of transport or container shall be anti-slip. Floors shall be designed, constructed and maintained to avoid discomfort, distress and injury to the animals and minimise leakage of urine and faeces. Materials used for floor construction shall be selected so as to minimise corrosion.

text: The means of transport or container shall be so designed and constructed as to provide access to the animals to allow them to be inspected, and if necessary watered, fed and cared for.

text: When animals need to be tied, appropriate equipment shall be provided in the means of transport.

text: Containers in which animals are transported shall be clearly and visibly marked to indicate the presence of live animals, with a sign indicating the top of the container.

text: Means of transport, containers and their fittings shall be designed and constructed to allow easy cleaning and disinfection.

text: Preparation for transport

text: Article 6 – Design and construction

text: For each journey, the person responsible for the transport of the animals shall be identified so that information on the organisation, carrying out and completion of the transport can be obtained at any time during the journey.

text: identification of the transporter and means of transport;

text: identification of the consignment and accompanying documents (animal species, number of animals, veterinary certificates);

text: the place and country of departure, places of transfer, places where animals are to be unloaded and rested and the place and country of destination.

text: Where the intended journey time exceeds eight hours for the transport of domestic solipeds and domestic animals of the bovine, ovine, caprine and porcine species, the person responsible for the transport shall draw up a document specifying the arrangements foreseen for the journey and in particular the following details:

text: The person responsible for the transport shall ensure that the intended journey complies with the respective rules of the countries of departure, transit and destination.

text: The person in charge of the welfare of the animals shall immediately record in the document mentioned in paragraph 2 the times and places at which the animals transported have been fed, watered and rested during the journey. This document shall be made available to the competent authority upon request.

text: No animal shall be transported unless suitable provisions are made in advance by the person responsible for the transport to safeguard its welfare throughout the journey. Where appropriate, arrangements shall be made to provide water, feed and rest, and any necessary care during the journey and on arrival at the place of destination, and to that end, appropriate notification shall be given in advance.

text: To avoid any delay, consignments of animals shall be accompanied by appropriate documentation and, at posts where importation and transit formalities have to be completed, an appropriate person shall be notified as early as possible.

text: The person responsible for the transport shall ensure that responsibility for the welfare of the animals during transport is clearly defined, from the time of departure to arrival at the point of destination, including loading and unloading.

text: Article 7 – Planning

text: In order to ensure the necessary care of the animals throughout the journey, consignments shall be accompanied by an attendant who is in charge of the welfare of the animals. The driver can perform the functions of attendant.

text: The attendant shall have received specific and appropriate training or have equivalent practical experience qualifying him/her to handle, transport and take care of animals, including in cases of emergency.

text: where the person responsible for the transport of animals has appointed an agent to care for the animals at appropriate rest, water and feed points;

text: where animals are transported in containers which are securely fastened, adequately ventilated and, where necessary, containing enough water and feed, in dispensers which cannot be tipped over, for a journey of twice the anticipated time.

text: Exceptions to the provisions of paragraph 1 may be made in the following cases:

text: Article 8 – Attendants

text: No animal shall be transported unless it is fit for the intended journey.

text: slightly injured or ill animals whose transport would not cause additional suffering;

text: animals transported for experimental or other scientific purposes approved by the relevant competent authority, if the illness or injury is part of the research programme;

text: the transport of animals under veterinary supervision for or following emergency treatment

text: Ill or injured animals shall not be considered fit for transport. However, this provision shall not apply to:

text: Special care shall be taken with the transport of animals in advanced stages of pregnancy, those having recently given birth and very young animals:

text: – pregnant female mammals shall not be transported during a period at least equal to 10% of the length of gestation before giving birth, nor during at least one week after giving birth;

text: – very young mammals shall not be transported before the navel is completely healed.

text: If all necessary precautions have been taken, under veterinary advice and on a case-by-case basis, exception can be made by the competent authority for registered mares with a foal at foot going to the stallion after foaling.

text: Sedatives shall not be used unless strictly necessary to ensure the welfare of the animals and shall only be used following veterinary advice, in accordance with national legislation.

text: Article 9 – Fitness for transport

text: Before animals are loaded for international transport they shall be inspected by an authorised veterinarian of the country where the journey starts, who shall ensure that they are fit for the journey.

text: The authorised veterinarian shall issue a certificate which identifies the animals, states that they are fit for the intended journey and, where possible, records the registration number or, where appropriate, the name or other means of identifying the means of transport and the type of transport used.

text: In certain cases determined by agreement between the Parties concerned, the provisions of this article need not apply.

text: Article 10 – Inspection/Certificate

text: Animals shall be prepared for the intended journey, be accustomed to the feed to be provided and be able to use the delivery systems for water and feed. They shall be provided with water, feed and a rest period as appropriate.

text: In order to reduce the stress of transport, due regard shall be paid to the need of certain categories of animals, such as wild animals, to become acclimatised to the mode of transport prior to the proposed journey.

text: Mixing of animals that have not been raised together or are not accustomed to one another shall be avoided as far as possible.

text: Loading and unloading

text: Article 11 – Rest, water and feed prior to loading

text: Animals shall be loaded and unloaded in such a way as to ensure that they are not caused injury or suffering.

text: Animals shall be loaded so as to ensure that space allowances (floor area and height) and separation requirements are met in accordance with

text: Article 17

text: Animals shall be loaded as close as possible to the time of departure from the place of dispatch.

text: On arrival at their destination, the animals shall be unloaded as soon as possible, offered an adequate quantity of water and, if necessary, be fed and allowed to rest.

text: Article 12 – Principles

text: Loading and unloading shall take place using a properly designed and constructed ramp, lift or loading bay except where animals are to be loaded and unloaded in purpose-built containers. Manual lifting is permissible if the animals are small enough, and even desirable in the case of young animals which might have difficulty in negotiating a ramp. All loading and unloading facilities shall be suitable for their purpose, stable and maintained in a good state of repair.

text: All ramps and surfaces on which animals walk shall be designed and maintained so as to prevent slipping and their slope shall be minimised as far as possible. Where their slope is steeper than 10°, they shall be fitted with a system, such as provided by foot battens, which ensures that the animals climb or go down without risks or difficulties. The equipment shall be provided with side barriers if necessary.

text: The interior of the transport unit shall be well-lit at loading so that the animals can see where they are going, depending upon the specific requirements of the species.

text: Animals shall be loaded only into a means of transport which has been thoroughly cleaned and, where appropriate, disinfected.

text: Goods which are being transported in the same means of transport as animals shall be positioned so that they do not cause injury, suffering or distress to the animals.

text: When containers loaded with animals are placed one on top of the other on the means of transport, the necessary precautions shall be taken to avoid urine and faeces falling on the animals placed underneath.

text: Article 13 – Equipment and procedures

text: Animals shall be handled calmly and gently in order to reduce unrest and agitation to a minimum, and in order to protect the animals from avoidable pain, distress and injury.

text: Noise, harassment and the use of excessive force during loading and unloading shall be avoided. Animals shall not be struck, nor shall pressure be applied to any particularly sensitive part of the body. In particular, animals' tails shall not be crushed, twisted or broken and their eyes shall not be grasped. Animals shall not be punched or kicked.

text: Animals themselves shall not be suspended by mechanical means, lifted or dragged by the head, ears, horns, antlers, legs, tail or fleece, or in any other painful way.

text: Instruments intended for guiding animals shall be used on animals solely for that purpose. The use of instruments which administer electric shocks shall be avoided as far as possible. In any case, these instruments shall only be used for adult bovine animals and adult pigs which refuse to move, and only when they have room ahead of them in which to move. Shocks shall last no longer than one second, be adequately spaced, and shall only be applied to the muscles of the hindquarters. Shocks shall not be used repeatedly if the animal fails to respond.

text: Persons handling animals shall not use prods or other implements with pointed ends. Sticks or other implements intended for guiding animals shall only be used provided they can be applied to the body of an animal without causing it injury or suffering.

text: Article 14 – Handling

text: animals of different species; b animals hostile to each other; c animals of significantly different sizes or ages; d uncastrated adult males; e tied and untied animals.

text: Animals shall be separated during transport where injury or suffering is likely to occur if they are mixed. This shall apply in particular to:

text: The provisions of paragraph 1 shall not apply where the animals have been raised in compatible groups, are accustomed to each other, where separation will cause distress or where females are accompanied by dependent young.

text: Transport practices

text: Article 15 – Separation

text: The floor surfaces of means of transport or containers shall be maintained so as to minimise the risk of slipping and leakage of urine and faeces. An appropriate bedding which absorbs urine and faeces and which provides an adequate resting material shall cover the floor of the means of transport or containers, unless an alternative method is used that provides at least the same advantages to the animals.

text: Article 16 – Floors and bedding

text: Animals shall be provided with adequate space to stand in their natural position in the means of transport or container. Space to lie down at the same time shall be provided unless the technical protocol or special conditions for the protection of animals require otherwise.

text: A technical protocol, drawn up in accordance with

text: Article 34

text: of this Convention, shall determine the minimum space allowances for animals.

text: To prevent injury by excessive movement, partitions shall be used to sub-divide large groups of animals or subdivide a pen which contains fewer animals than its normal capacity, which otherwise would have too much space.

text: Partitions shall be appropriate to the size and species of the animals, and shall be positioned, secured and maintained so as to prevent injury or suffering to the animals.

text: Article 17 – Space allowances (floor area and height)

text: When animals are tied, the ropes, the tethers or other means used shall be strong enough not to break during normal transport conditions, and long enough to allow the animals, if necessary, to lie down and to eat and drink. They shall be designed in such a way as to eliminate any danger of strangulation or injury. Animals shall not be tied by the horns, antlers, legs, nose-rings nor be transported having their legs tied together. Animals shall be tied only with devices allowing them to be quickly released.

text: Article 18 – Tying of animals

text: Sufficient ventilation shall be provided to ensure that the needs of the animals are fully met, taking into account in particular the number and type of the animals to be transported and the expected weather conditions during the journey. 2 Containers shall be stowed in a way which does not impede their ventilation. 3 Where animals are to be transported in adverse conditions of temperature and humidity, suitable arrangements shall be taken to safeguard their welfare.

text: Article 19 – Ventilation and temperature

text: During transport, animals shall be offered water, feed and the opportunity to rest as appropriate to their species and age, at suitable intervals. 2 A technical protocol, drawn up in accordance with

text: Article 34

text: of this Convention, will determine the maximum travelling times and minimum watering and feeding intervals and resting periods. 3 Water and feed shall be of good quality and presented to the animals in a way which minimises contamination.

text: Article 20 – Water, feed and rest

text: Lactating females not accompanied by their offspring shall not be transported for long periods. However, where this is unavoidable, they shall be milked shortly before loading and at intervals of not more than twelve hours during the course of a journey.

text: Article 21 – Females in lactation

text: The means of transport shall be equipped with a means of lighting, fixed or portable, sufficient for general inspection of the animals and where this is necessary during transport and for watering and feeding.

text: Article 22 – Lighting

text: During transport and handling, containers shall always be kept upright and severe jolts or shaking shall be minimised. 2 Containers shall be secured so as to prevent their displacement by the motion of the means of transport.

text: Article 23 – Containers

text: The person in charge of the welfare of the animals shall take every opportunity to check them and to administer, if necessary, the appropriate care.

text: Article 24 – Care during transport

text: Animals that fall ill or are injured during transport shall receive first-aid care as soon as possible; if necessary, they shall be given appropriate veterinary treatment or be killed in a way which does not cause them any additional suffering.

text: Special provisions

text: Article 25 – Emergency and casualty care during transport

text: Any railway wagon used in the transport of animals shall be marked to indicate the presence of live animals. Unless the animals are transported in containers, the inside walls of the railway wagon shall be of suitable material, completely smooth and fitted with rings or bars, at a suitable height, to which the animals may be attached. 2 Where they are not transported in individual boxes, solipeds shall be tied in such a way that they are all facing the same side of the railway wagon or tied facing each other. However, foals and unbroken animals shall not be tied. 3 Large animals shall be loaded in such a way as to allow an attendant to move between them. 4 When assembling trains and during all other movement of railway wagons every precaution shall be taken to avoid jolting a wagon containing animals. 5 Every opportunity shall be taken to check the animals, as provided for in

text: Article 24

text: of this Convention, whenever the railway wagons stop or weather conditions change.

text: Article 26 – Special provisions for transport by rail

text: Vehicles in which animals are transported shall be clearly and visibly marked to indicate the presence of live animals. 2 Vehicles shall be driven in a way which ensures smooth acceleration, deceleration and turning. 3 Vehicles shall carry suitable equipment for loading and unloading in compliance with

text: Article 13

text: of this Convention. 4 Every opportunity shall be taken to check the animals in the vehicle, as provided for in

text: Article 24

text: of this Convention, whenever the vehicle stops or weather conditions change.

text: Article 27 – Special provisions for transport by road

text: So as to ensure that the welfare requirements of the animals transported are met, the competent authority of the country where loading takes place shall inspect before loading is allowed: a purpose-built or converted livestock vessels; b arrangements on other vessels where the animals are to be transported. 2 An alarm shall be fitted to detect any power failure in the forced ventilation system. An adequate secondary source of power, clearly separated from the primary source, shall be provided to ensure that appropriate forced ventilation is maintained. 3 Animals shall not be transported on open decks unless in containers or other structures, giving adequate protection from sea water. 4 Where animals are walked on and off the vessel, suitable gangways, ramps and walkways shall be provided between the quayside and the vessel's livestock decks.

text: Loading and unloading of animals onto or off livestock vessels shall be supervised by an authorised veterinarian.

text: Animal accommodation, ramps and passageways shall be adequately lit at loading and unloading so that the animals can see where they are going, depending upon the specific requirements of the species.

text: All pens, stalls and containers shall be directly accessible for both the animals and attendants.

text: Passageways for animals shall be appropriate for the species to be transported, in particular they shall not have sharp edges, and sharp corners and protrusions shall be minimised.

text: All parts of the vessel where animals are accommodated shall be provided with facilities which ensure effective drainage and shall be kept in a good sanitary condition.

text: Supplies of clean fresh water, wholesome feed and appropriate bedding, sufficient for the animals’ needs and considering the length of the sea journey, shall be carried on the vessel.

text: Reserve supplies of water, and in the case of long journeys, feed and bedding for the animals shall be carried in case of unforeseen delays.

text: Supplies of feed and bedding shall be stored so as to ensure that they are kept in a dry state, and protected from the weather and the sea. The storage of feed and bedding shall not interfere with ventilation, lighting and drainage systems, or passageways.

text: Drinking and feeding equipment appropriate to the number, size and species of the animals shall be provided.

text: Provisions shall be made for isolating animals which become ill or injured during the journey.

text: In case of emergency, it shall be possible to kill an animal in accordance with the provisions laid down in

text: Article 25

text: of this Convention. To that end, a means of killing suitable to the species shall be available.

text: Article 28 – Special provisions for transport by water (except roll-on/roll-off vessels)

text: Where animals are transported in road vehicles or rail wagons on board roll-on/roll-off vessels, especially in the enclosed decks, special care shall be taken to ensure that sufficient ventilation is provided for the animals throughout the journey. Road vehicles and rail wagons shall be stowed so that the animals obtain maximum benefit from fresh air inlets.

text: The person in charge of the welfare of the animals shall have access to them so that they can be inspected and, if necessary, cared for, watered and fed during the journey.

text: Road vehicles, rail wagons and containers shall be equipped with a sufficient number of adequately designed, positioned and maintained securing points enabling them to be securely fastened to the vessel. Road vehicles, rail wagons and containers shall be secured to the ship before the start of the sea journey to prevent them being displaced by the motion of the vessel.

text: Road vehicles and rail wagons containing animals shall only be transported on the open deck of a vessel in a position that provides adequate protection from sea water, taking account of the protection which the road vehicle or rail wagon itself provides.

text: An alarm shall be fitted to detect any power failure in the forced ventilation system of the vessel. An adequate secondary source of power shall be provided to ensure that appropriate forced ventilation is maintained.

text: Arrangements shall be made to supply the animals with fresh water and feed in case of unforeseen delays or if otherwise necessary.

text: In case of emergency, if transport lasts more than two hours, it shall be possible to kill an animal in accordance with the provisions laid down in

text: Article 25

text: Article 29 – Special provisions for transport in road vehicles or rail wagons on rollon/roll-off vessels

text: No animals shall be transported in conditions where air quality, temperature and pressure cannot be maintained within an appropriate range during the entire journey.

text: The commander shall be advised of the species, location and quantity of all live animals aboard the aircraft, together with any action required. For animals in accessible cargo compartments, the commander shall be notified of any irregularity relating to the animals as soon as possible.

text: Animals shall be loaded in the aircraft as close as possible to the aircraft’s planned time of departure.

text: Drugs shall only be used when a specific problem exists and shall be administered by a veterinarian or by another competent person who has been instructed in their use. The commander shall be informed as soon as possible of any drugs administered in flight.

text: In the case of emergency and where an attendant has access to the animals, in accordance with

text: Article 25

text: of this Convention, a means of sedation and/or euthanasia, suitable to the species, shall be available and only used with the agreement of the commander.

text: The attendant shall be briefed on the in-flight communication procedure prior to flight departure and be able to effectively communicate with the crew.

text: Multilateral consultations

text: Article 30 – Special provisions for transport by air

text: The Parties shall, within five years from the entry into force of this Convention and every five years thereafter, or more frequently if a majority of the Parties should so request, hold multilateral consultations within the Council of Europe.

text: These consultations shall take place at meetings convened by the Secretary General of the Council of Europe.

text: Each Party shall have the right to appoint one or more representatives to participate in these consultations. The Parties shall communicate the name(s) of their representative(s) to the Secretary General of the Council of Europe at least one month before each meeting. Each Party shall have the right to vote. Each State which is Party to the Convention shall have one vote.

text: Within the areas of its competence, the European Community, on becoming Party to the Convention, shall exercise its right to vote with a number of votes equal to the number of its member States which are Parties to this Convention; the European Community shall not exercise its right to vote in cases where the member States concerned exercise theirs, and conversely.

text: The Parties may seek the advice of experts. They may, on their own initiative or at the request of the body concerned, invite any international or national, governmental or non-governmental body technically qualified in the fields covered by this Convention to be represented by an observer at one or part of one of its consultations. The decision to invite such experts or bodies shall be taken by a majority of two-third of the votes cast.

text: After each consultation, the Parties shall submit to the Committee of Ministers of the Council of Europe a report on the consultation and the functioning of the Convention.

text: Subject to the provisions of this Convention, the Parties shall draw up the rules of procedure for the consultations.

text: Article 31 – Multilateral consultations

text: Within the framework of multilateral consultations, the Parties shall be responsible for following the application of this Convention. They may in particular:

text: prepare technical protocols to this Convention in accordance with the provisions of

text: Article 34

text: suggest any necessary modifications to this Convention and examine those proposed in accordance with the provisions of

text: Article 35

text: examine, at the request of one or more Parties, questions concerning the interpretation of this Convention;

text: make recommendations to the Committee of Ministers concerning States to be invited to accede to this Convention.

text: Technical protocols

text: Article 32 – Functions of multilateral consultations

text: The Parties shall adopt technical protocols to this Convention concerning space allowances (

text: Article 17

text: ) and water, feed and rest (

text: Article 20

text: ). They may also adopt other technical protocols with a view to establishing technical norms for the implementation of the provisions contained in this Convention.

text: Article 33 – Object

text: A technical protocol shall be adopted by a two-thirds majority of the votes cast, and then forwarded to the Committee of Ministers for approval. After its approval, this text shall be forwarded to the Parties for acceptance.

text: A technical protocol shall enter into force, in respect of those Parties which have accepted it, on the first day of the month following the expiration of a period of one month after the date on which three Parties, including at least two member States of the Council of Europe, have informed the Secretary General that they have accepted it. In respect of any Party which subsequently accepts it, the protocol shall enter into force on the first day of the month following the expiration of a period of one month after the date on which that Party has informed the Secretary General of its acceptance.

text: For the purpose of preparing technical protocols, the Parties shall follow developments in scientific research and new methods in animal transport.

text: Article 34 – Adoption and entry into force

text: Any amendment to a technical protocol to this Convention, proposed by a Party or by the Committee of Ministers, shall be communicated to the Secretary General of the Council of Europe and forwarded by him or her to the member States of the Council of Europe, to the European Community and to any non-member State which has acceded to, or has been invited to accede to this Convention in accordance with the provisions of

text: Article 38

text: Any amendment proposed in accordance with the provisions of the preceding paragraph shall be examined not less than six months after the date of forwarding by the Secretary General at a multilateral consultation, where it may be adopted by a two-thirds majority of the Parties. The text adopted shall be forwarded to the Parties.

text: On the first day of the month following the expiration of a period of eighteen months after its adoption by the multilateral consultation, unless more than one-third of the Parties have notified objections, any amendment shall enter into force for those Parties which have not notified objections.

text: Settlement of disputes

text: Article 35 – Amendments

text: In case of a dispute regarding the interpretation or the application of the provisions of this Convention, the competent authorities of the Parties concerned shall consult with each other. Each Party shall communicate to the Secretary General of the Council of Europe the names and addresses of their competent authorities.

text: If the dispute has not been settled by this means, it shall, at the request of one or other of the parties to the dispute, be referred to arbitration. Each party shall nominate an arbitrator and the two arbitrators shall nominate a referee. If one of the two parties to the dispute has not nominated its arbitrator within the three months following the request for arbitration, he shall be nominated at the request of the other party to the dispute by the President of the European Court of Human Rights. If the latter is a national of one of the parties to the dispute, this duty shall be carried out by the Vice-President of the Court or, if the Vice-President is a national of one of the parties to the dispute, by the most senior judge of the Court not being a national of one of the parties to the dispute. The same procedure shall be observed if the arbitrators cannot agree on the choice of referee.

text: In the event of a dispute between two Parties, one of which is a member State of the European Community, the latter itself being a Party, the other Party shall address the request for arbitration both to the member State and to the Community, which jointly shall notify it, within three months of receipt of the request, whether the member State or the Community, or the member State and the Community jointly, shall be party to the dispute. In the absence of such notification within the said time limit, the member State and the Community shall be considered as being one and the same party to the dispute for the purposes of the application of the provisions governing the constitution and procedure of the arbitration tribunal. The same shall apply when the member State and the Community jointly present themselves as party to the dispute.

text: The arbitration tribunal shall lay down its own procedure. Its decisions shall be taken by majority vote. Its award, which shall be based on this Convention, shall be final.

text: The procedure for the settlement of disputes shall not apply to disputes relating to questions within the competence of the European Community or to the definition of the scope of that competence between Parties which are members of the European Community or between such members and the Community.

text: Final clauses

text: Article 36 – Settlement of disputes

text: This Convention shall be open for signature by the member States of the Council of Europe and the European Community. It is subject to ratification, acceptance or approval. Instruments of ratification, acceptance or approval shall be deposited with the Secretary General of the Council of Europe.

text: No State Party to the European Convention on the Protection of Animals during International Transport, opened for signature in Paris on 13 December 1968, may deposit its instrument of ratification, acceptance or approval unless it has already denounced the said Convention or denounces it simultaneously.

text: This Convention shall enter into force six months after the date on which four States have expressed their consent to be bound by this Convention in accordance with the provisions of the preceding paragraphs.

text: Whenever, in application of the preceding two paragraphs, the denunciation of the Convention of 13 December 1968 would not become effective simultaneously with the entry into force of this Convention, a Contracting State or the European Community may, when depositing its instrument of ratification, acceptance or approval, declare that it will continue to apply the Convention of 13 December 1968 until the entry into force of this Convention.

text: In respect of any signatory State or the European Community which subsequently expresses its consent to be bound by it, this Convention shall enter into force six months after the date of the deposit of the instrument of ratification, acceptance or approval.

text: Article 37 – Signature, ratification, acceptance, approval

text: After the entry into force of this Convention, the Committee of Ministers of the Council of Europe may invite any other non-member State of the Council to accede to this Convention by a decision taken by the majority provided for in

text: Article 20

text: .d of the Statute of the Council of Europe and by the unanimous vote of the representatives of the Contracting States entitled to sit on the Committee.

text: In respect of any acceding State, this Convention shall enter into force six months after the date of deposit of the instrument of accession with the Secretary General of the Council of Europe.

text: Article 38 – Accession of non-member States

text: Any State or the European Community may at any later date, by a declaration addressed to the Secretary General of the Council of Europe, extend the application of this Convention to any other territory specified in the declaration. In respect of such territory this Convention shall enter into force six months after the date of receipt of such declaration by the Secretary General.

text: Any declaration made under the two preceding paragraphs may, in respect of any territory specified in such declaration, be withdrawn by a notification addressed to the Secretary General. The withdrawal shall become effective six months after the date of receipt of such notification by the Secretary General.

text: Article 39 – Territorial clause

text: Any Party may at any time denounce this Convention by means of a notification addressed to the Secretary General of the Council of Europe. 2 Such denunciation shall become effective six months following the date of receipt of such notification by the Secretary General.

text: Article 40 – Denunciation

text: The Secretary General of the Council of Europe shall notify the member States of the Council of Europe, the European Community and any State which has acceded or has been invited to accede to this Convention of: a any signature; b the deposit of any instrument of ratification, acceptance, approval or accession; c any date of entry into force of this Convention in accordance with

text: Articles 37

text: and 38; d any other act, notification or communication relating to this Convention.

text: In witness whereof the undersigned, being duly authorised thereto, have signed this Convention. Done at Chişinau, this 6th day of November 2003, in English and French, both texts being equally authentic, in a single copy which shall be deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe shall transmit certified copies to each member State of the Council of Europe, to the European Community and to any State invited to accede to this Convention.

text: Article 41 – Notifications


doctype: protocol

identifier: CETS No. 194

openingPlace: Strasbourg

publisher: Council of Europe Treaty Office

reference: CETS No. 194

title: Protocol No. 14 to the Convention for the Protection of Human Rights and Fundamental Freedoms, amending the control system of the Convention

text: Council of Europe Treaty Series - No. 194

type: stycke

text: Strasbourg, 13.V.2004

text: Preamble

text: The member States of the Council of Europe, signatories to this

text: Protocol to the Convention for the Protection of Human Rights and Fundamental Freedoms

text: , signed at Rome on 4 November 1950 (hereinafter referred to as “the Convention”), Having regard to Resolution No. 1 and the Declaration adopted at the European Ministerial Conference on Human Rights, held in Rome on 3 and 4 November 2000; Having regard to the Declarations adopted by the Committee of Ministers on 8 November 2001, 7 November 2002 and 15 May 2003, at their 109th, 111th and 112th Sessions, respectively; Having regard to Opinion No. 251 (2004) adopted by the Parliamentary Assembly of the Council of Europe on 28 April 2004; Considering the urgent need to amend certain provisions of the Convention in order to maintain and improve the efficiency of the control system for the long term, mainly in the light of the continuing increase in the workload of the European Court of Human Rights and the Committee of Ministers of the Council of Europe; Considering, in particular, the need to ensure that the Court can continue to play its preeminent role in protecting human rights in Europe, Have agreed as follows:

text: Paragraph 2 of

text: Article 22

text: of the Convention shall be deleted.

text: Article 1

type: artikel

text: Article 23 of the Convention shall be amended to read as follows:

text: “Article 23 – Terms of office and dismissal

text: The judges shall be elected for a period of nine years. They may not be re-elected. 2 The terms of office of judges shall expire when they reach the age of 70.

text: CETS 194 – Human Rights (Protocol No. 14), 13.V.2004 __________________________________________________________________________________

text: The judges shall hold office until replaced. They shall, however, continue to deal with such cases as they already have under consideration. 4 No judge may be dismissed from office unless the other judges decide by a majority of two-thirds that that judge has ceased to fulfil the required conditions.”

text: Article 2

text: Article 24 of the Convention shall be deleted.

text: Article 3

text: Article 25 of the Convention shall become Article 24 and its text shall be amended to read as follows:

text: “Article 24 – Registry and rapporteurs

text: The Court shall have a registry, the functions and organisation of which shall be laid down in the rules of the Court. 2 When sitting in a single-judge formation, the Court shall be assisted by rapporteurs who shall function under the authority of the President of the Court. They shall form part of the Court’s registry.”

text: Article 4

text: Article 26 of the Convention shall become Article 25 (“Plenary Court”) and its text shall be amended as follows: 1 At the end of paragraph d, the comma shall be replaced by a semi-colon and the word “and” shall be deleted. 2 At the end of paragraph e, the full stop shall be replaced by a semi-colon. 3 A new paragraph f shall be added which shall read as follows: “f make any request under Article 26, paragraph 2.”

text: Article 5

text: Article 27 of the Convention shall become Article 26 and its text shall be amended to read as follows:

text: “Article 26 – Single-judge formation, committees, Chambers and Grand Chamber

text: To consider cases brought before it, the Court shall sit in a single-judge formation, in committees of three judges, in Chambers of seven judges and in a Grand Chamber of seventeen judges. The Court’s Chambers shall set up committees for a fixed period of time. 2 At the request of the plenary Court, the Committee of Ministers may, by a unanimous decision and for a fixed period, reduce to five the number of judges of the Chambers. 3 When sitting as a single judge, a judge shall not examine any application against the High Contracting Party in respect of which that judge has been elected.

text: There shall sit as an ex officio member of the Chamber and the Grand Chamber the judge elected in respect of the High Contracting Party concerned. If there is none or if that judge is unable to sit, a person chosen by the President of the Court from a list submitted in advance by that Party shall sit in the capacity of judge.

text: The Grand Chamber shall also include the President of the Court, the Vice-Presidents, the Presidents of the Chambers and other judges chosen in accordance with the rules of the Court. When a case is referred to the Grand Chamber under Article 43, no judge from the Chamber which rendered the judgment shall sit in the Grand Chamber, with the exception of the President of the Chamber and the judge who sat in respect of the High Contracting Party concerned.”

text: Article 6

text: After the new Article 26, a new Article 27 shall be inserted into the Convention, which shall read as follows:

text: “Article 27 – Competence of single judges

text: A single judge may declare inadmissible or strike out of the Court’s list of cases an application submitted under Article 34, where such a decision can be taken without further examination.

text: The decision shall be final.

text: If the single judge does not declare an application inadmissible or strike it out, that judge shall forward it to a committee or to a Chamber for further examination.”

text: Article 7

text: Article 28 of the Convention shall be amended to read as follows:

text: “Article 28 – Competence of committees

ordinal: a

text: declare it inadmissible or strike it out of its list of cases, where such decision can be taken without further examination; or

type: punkt

ordinal: b

text: declare it admissible and render at the same time a judgment on the merits, if the underlying question in the case, concerning the interpretation or the application of the Convention or the Protocols thereto, is already the subject of well-established case-law of the Court.

text: In respect of an application submitted under Article 34, a committee may, by a unanimous vote,

text: Decisions and judgments under paragraph 1 shall be final.

text: If the judge elected in respect of the High Contracting Party concerned is not a member of the committee, the committee may at any stage of the proceedings invite that judge to take the place of one of the members of the committee, having regard to all relevant factors, including whether that Party has contested the application of the procedure under paragraph 1.b.”

text: Article 8

text: Article 29 of the Convention shall be amended as follows: 1 Paragraph 1 shall be amended to read as follows: “If no decision is taken under Article 27 or 28, or no judgment rendered under Article 28, a Chamber shall decide on the admissibility and merits of individual applications submitted under Article 34. The decision on admissibility may be taken separately.” 2 At the end of paragraph 2 a new sentence shall be added which shall read as follows: “The decision on admissibility shall be taken separately unless the Court, in exceptional cases, decides otherwise.” 3 Paragraph 3 shall be deleted.

text: Article 9

text: Article 31 of the Convention shall be amended as follows: 1 At the end of paragraph a, the word “and” shall be deleted. 2 Paragraph b shall become paragraph c and a new paragraph b shall be inserted and shall read as follows: “b decide on issues referred to the Court by the Committee of Ministers in accordance with Article 46, paragraph 4; and”.

text: Article 10

text: Article 32 of the Convention shall be amended as follows: At the end of paragraph 1, a comma and the number 46 shall be inserted after the number 34.

text: Article 11

text: Paragraph 3 of Article 35 of the Convention shall be amended to read as follows: “3 The Court shall declare inadmissible any individual application submitted under Article 34 if it considers that: a the application is incompatible with the provisions of the Convention or the Protocols thereto, manifestly ill-founded, or an abuse of the right of individual application; or b the applicant has not suffered a significant disadvantage, unless respect for human rights as defined in the Convention and the Protocols thereto requires an examination of the application on the merits and provided that no case may be rejected on this ground which has not been duly considered by a domestic tribunal.”

text: Article 12

text: A new paragraph 3 shall be added at the end of Article 36 of the Convention, which shall read as follows: “3 In all cases before a Chamber or the Grand Chamber, the Council of Europe Commissioner for Human Rights may submit written comments and take part in hearings.”

text: Article 13

text: Article 38 of the Convention shall be amended to read as follows:

text: “Article 38 – Examination of the case

text: The Court shall examine the case together with the representatives of the parties and, if need be, undertake an investigation, for the effective conduct of which the High Contracting Parties concerned shall furnish all necessary facilities.”

text: Article 14

text: Article 39 of the Convention shall be amended to read as follows:

text: “Article 39 – Friendly settlements

text: At any stage of the proceedings, the Court may place itself at the disposal of the parties concerned with a view to securing a friendly settlement of the matter on the basis of respect for human rights as defined in the Convention and the Protocols thereto. 2 Proceedings conducted under paragraph 1 shall be confidential. 3 If a friendly settlement is effected, the Court shall strike the case out of its list by means of a decision which shall be confined to a brief statement of the facts and of the solution reached. 4 This decision shall be transmitted to the Committee of Ministers, which shall supervise the execution of the terms of the friendly settlement as set out in the decision.”

text: Article 15

text: Article 46 of the Convention shall be amended to read as follows:

text: “Article 46 – Binding force and execution of judgments

text: The High Contracting Parties undertake to abide by the final judgment of the Court in any case to which they are parties. 2 The final judgment of the Court shall be transmitted to the Committee of Ministers, which shall supervise its execution. 3 If the Committee of Ministers considers that the supervision of the execution of a final judgment is hindered by a problem of interpretation of the judgment, it may refer the matter to the Court for a ruling on the question of interpretation. A referral decision shall require a majority vote of two thirds of the representatives entitled to sit on the Committee. 4 If the Committee of Ministers considers that a High Contracting Party refuses to abide by a final judgment in a case to which it is a party, it may, after serving formal notice on that Party and by decision adopted by a majority vote of two thirds of the representatives entitled to sit on the Committee, refer to the Court the question whether that Party has failed to fulfil its obligation under paragraph 1.

text: If the Court finds a violation of paragraph 1, it shall refer the case to the Committee of Ministers for consideration of the measures to be taken. If the Court finds no violation of paragraph 1, it shall refer the case to the Committee of Ministers, which shall close its examination of the case.”

text: Article 16

text: Article 59 of the Convention shall be amended as follows: 1 A new paragraph 2 shall be inserted which shall read as follows: “2 The European Union may accede to this Convention.” 2 Paragraphs 2, 3 and 4 shall become paragraphs 3, 4 and 5 respectively.

text: Final and transitional provisions

text: Article 17

text: This Protocol shall be open for signature by member States of the Council of Europe signatories to the Convention, which may express their consent to be bound by a signature without reservation as to ratification, acceptance or approval; or b signature subject to ratification, acceptance or approval, followed by ratification, acceptance or approval. 2 The instruments of ratification, acceptance or approval shall be deposited with the Secretary General of the Council of Europe.

text: Article 18

text: This Protocol shall enter into force on the first day of the month following the expiration of a period of three months after the date on which all Parties to the Convention have expressed their consent to be bound by the Protocol, in accordance with the provisions of

text: Article 18

text: Article 19

text: From the date of the entry into force of this Protocol, its provisions shall apply to all applications pending before the Court as well as to all judgments whose execution is under supervision by the Committee of Ministers. 2 The new admissibility criterion inserted by

text: Article 12

text: of this Protocol in Article 35, paragraph 3.b of the Convention, shall not apply to applications declared admissible before the entry into force of the Protocol. In the two years following the entry into force of this Protocol, the new admissibility criterion may only be applied by Chambers and the Grand Chamber of the Court.

text: Article 20

text: The term of office of judges serving their first term of office on the date of entry into force of this Protocol shall be extended ipso jure so as to amount to a total period of nine years. The other judges shall complete their term of office, which shall be extended ipso jure by two years.

text: Article 21

text: The Secretary General of the Council of Europe shall notify the member States of the Council of Europe of: a any signature; b the deposit of any instrument of ratification, acceptance or approval; c the date of entry into force of this Protocol in accordance with

text: Article 19

text: ; and d any other act, notification or communication relating to this Protocol.

text: In witness whereof, the undersigned, being duly authorised thereto, have signed this Protocol. Done at Strasbourg, this 13th day of May 2004, in English and in French, both texts being equally authentic, in a single copy which shall be deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe shall transmit certified copies to each member State of the Council of Europe.

text: Article 22

type: internationell-overenskommelse


identifier: CETS No. 195

reference: CETS No. 195

title: Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research

text: Council of Europe Treaty Series - No. 195

text: Additional Protocol to the Convention on Human Rights and Biomedicine,

text: concerning Biomedical Research

text: Strasbourg, 25.I.2005

text: Preamble

text: The member States of the Council of Europe, the other States and the European Community signatories to this Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (hereinafter referred to as “the Convention”),

text: Considering that the aim of the Council of Europe is the achievement of greater unity between its members and that one of the methods by which this aim is pursued is the maintenance and further realisation of human rights and fundamental freedoms;

text: Considering that the aim of the Convention, as defined in

text: Article 1

text: , is to protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine;

text: Considering that progress in medical and biological sciences, in particular advances obtained through biomedical research, contributes to saving lives and improving quality of life;

text: Conscious of the fact that the advancement of biomedical science and practice is dependent on knowledge and discovery which necessitates research on human beings;

text: Stressing that such research is often transdisciplinary and international;

text: Taking into account national and international professional standards in the field of biomedical research and the previous work of the Committee of Ministers and the Parliamentary Assembly of the Council of Europe in this field;

text: Convinced that biomedical research that is contrary to human dignity and human rights should never be carried out;

text: Stressing the paramount concern to be the protection of the human being participating in research;

text: Affirming that particular protection shall be given to human beings who may be vulnerable in the context of research;

text: _____ (*) The Treaty of Lisbon amending the Treaty on European Union and the Treaty establishing the European Community entered into force on 1 December 2009. As a consequence, as from that date, any reference to the European Economic Community shall be read as the European Union.

text: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005 __________________________________________________________________________________

text: Recognising that every person has a right to accept or refuse to undergo biomedical research and that no one should be forced to undergo such research; Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to biomedical research, Have agreed as follows:

text: CHAPTER I – Object and scope

type: rubrik

text: Parties to this Protocol shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to any research involving interventions on human beings in the field of biomedicine.

text: Article 1 – Object and purpose

text: This Protocol covers the full range of research activities in the health field involving interventions on human beings. 2 This Protocol does not apply to research on embryos in vitro. It does apply to research on foetuses and embryos in vivo. 3 For the purposes of this Protocol, the term “intervention” includes: i a physical intervention, and ii any other intervention in so far as it involves a risk to the psychological health of the person concerned.

text: Article 2 – Scope

text: CHAPTER II – General provisions

text: The interests and welfare of the human being participating in research shall prevail over the sole interest of society or science.

text: Article 3 – Primacy of the human being

text: Research shall be carried out freely, subject to the provisions of this Protocol and the other legal provisions ensuring the protection of the human being.

text: Article 4 – General rule

text: Research on human beings may only be undertaken if there is no alternative of comparable effectiveness.

text: Article 5 – Absence of alternatives

text: Research shall not involve risks and burdens to the human being disproportionate to its potential benefits.

text: In addition, where the research does not have the potential to produce results of direct benefit to the health of the research participant, such research may only be undertaken if the research entails no more than acceptable risk and acceptable burden for the research participant. This shall be without prejudice to the provision contained in

text: Article 15

text: paragraph 2, sub-paragraph ii for the protection of persons not able to consent to research.

text: Article 6 – Risks and benefits

text: Research may only be undertaken if the research project has been approved by the competent body after independent examination of its scientific merit, including assessment of the importance of the aim of research, and multidisciplinary review of its ethical acceptability.

text: Article 7 – Approval

text: Any research must be scientifically justified, meet generally accepted criteria of scientific quality and be carried out in accordance with relevant professional obligations and standards under the supervision of an appropriately qualified researcher.

text: Article 8 – Scientific quality

text: CHAPTER III – Ethics committee

text: Every research project shall be submitted for independent examination of its ethical acceptability to an ethics committee. Such projects shall be submitted to independent examination in each State in which any research activity is to take place.

text: The purpose of the multidisciplinary examination of the ethical acceptability of the research project shall be to protect the dignity, rights, safety and well-being of research participants. The assessment of the ethical acceptability shall draw on an appropriate range of expertise and experience adequately reflecting professional and lay views.

text: The ethics committee shall produce an opinion containing reasons for its conclusion.

text: Article 9 – Independent examination by an ethics committee

text: Parties to this Protocol shall take measures to assure the independence of the ethics committee. That body shall not be subject to undue external influences.

text: Members of the ethics committee shall declare all circumstances that might lead to a conflict of interest. Should such conflicts arise, those involved shall not participate in that review.

text: Article 10 – Independence of the ethics committee

text: All information which is necessary for the ethical assessment of the research project shall be given in written form to the ethics committee.

text: In particular, information on items contained in the appendix to this Protocol shall be provided, in so far as it is relevant for the research project. The appendix may be amended by the Committee set up by

text: Article 32

text: of the Convention by a two-thirds majority of the votes cast.

text: Article 11 – Information for the ethics committee

text: The ethics committee must be satisfied that no undue influence, including that of a financial nature, will be exerted on persons to participate in research. In this respect, particular attention must be given to vulnerable or dependent persons.

text: Article 12 – Undue influence

text: CHAPTER IV – Information and consent

text: The persons being asked to participate in a research project shall be given adequate information in a comprehensible form. This information shall be documented.

ordinal: i

text: of the nature, extent and duration of the procedures involved, in particular, details of any burden imposed by the research project;

ordinal: v

text: of arrangements for access to information relevant to the participant arising from the research and to its overall results;

text: The information shall cover the purpose, the overall plan and the possible risks and benefits of the research project, and include the opinion of the ethics committee. Before being asked to consent to participate in a research project, the persons concerned shall be specifically informed, according to the nature and purpose of the research:

text: ii of available preventive, diagnostic and therapeutic procedures;

text: iii of the arrangements for responding to adverse events or the concerns of research participants;

text: iv of arrangements to ensure respect for private life and ensure the confidentiality of personal data;

text: vi of the arrangements for fair compensation in the case of damage;

text: vii of any foreseen potential further uses, including commercial uses, of the research results, data or biological materials;

text: viii of the source of funding of the research project.

text: In addition, the persons being asked to participate in a research project shall be informed of the rights and safeguards prescribed by law for their protection, and specifically of their right to refuse consent or to withdraw consent at any time without being subject to any form of discrimination, in particular regarding the right to medical care.

text: Article 13 – Information for research participants

text: No research on a person may be carried out, subject to the provisions of both Chapter V and

text: Article 19

text: , without the informed, free, express, specific and documented consent of the person. Such consent may be freely withdrawn by the person at any phase of the research.

text: Refusal to give consent or the withdrawal of consent to participation in research shall not lead to any form of discrimination against the person concerned, in particular regarding the right to medical care.

text: Where the capacity of the person to give informed consent is in doubt, arrangements shall be in place to verify whether or not the person has such capacity.

text: Article 14 – Consent

text: CHAPTER V – Protection of persons not able to consent to research

text: the results of the research have the potential to produce real and direct benefit to his or her health;

text: the person concerned does not object.

text: Research on a person without the capacity to consent to research may be undertaken only if all the following specific conditions are met:

text: ii research of comparable effectiveness cannot be carried out on individuals capable of giving consent;

text: iii the person undergoing research has been informed of his or her rights and the safeguards prescribed by law for his or her protection, unless this person is not in a state to receive the information;

text: iv the necessary authorisation has been given specifically and in writing by the legal representative or an authority, person or body provided for by law, and after having received the information required by

text: Article 16

text: , taking into account the person’s previously expressed wishes or objections. An adult not able to consent shall as far as possible take part in the authorisation procedure. The opinion of a minor shall be taken into consideration as an increasingly determining factor in proportion to age and degree of maturity;

text: the research has the aim of contributing, through significant improvement in the scientific understanding of the individual's condition, disease or disorder, to the ultimate attainment of results capable of conferring benefit to the person concerned or to other persons in the same age category or afflicted with the same disease or disorder or having the same condition;

text: Exceptionally and under the protective conditions prescribed by law, where the research has not the potential to produce results of direct benefit to the health of the person concerned, such research may be authorised subject to the conditions laid down in paragraph 1, subparagraphs ii, iii, iv, and v above, and to the following additional conditions:

text: ii the research entails only minimal risk and minimal burden for the individual concerned; and any consideration of additional potential benefits of the research shall not be used to justify an increased level of risk or burden.

text: Objection to participation, refusal to give authorisation or the withdrawal of authorisation to participate in research shall not lead to any form of discrimination against the person concerned, in particular regarding the right to medical care.

text: Article 15 – Protection of persons not able to consent to research

text: Those being asked to authorise participation of a person in a research project shall be given adequate information in a comprehensible form. This information shall be documented.

text: The information shall cover the purpose, the overall plan and the possible risks and benefits of the research project, and include the opinion of the ethics committee. They shall further be informed of the rights and safeguards prescribed by law for the protection of those not able to consent to research and specifically of the right to refuse or to withdraw authorisation at any time, without the person concerned being subject to any form of discrimination, in particular

text: regarding the right to medical care. They shall be specifically informed according to the nature and purpose of the research of the items of information listed in

text: Article 13

text: The information shall also be provided to the individual concerned, unless this person is not in a state to receive the information.

text: Article 16 – Information prior to authorisation

text: For the purposes of this Protocol it is deemed that the research bears a minimal risk if, having regard to the nature and scale of the intervention, it is to be expected that it will result, at the most, in a very slight and temporary negative impact on the health of the person concerned.

text: It is deemed that it bears a minimal burden if it is to be expected that the discomfort will be, at the most, temporary and very slight for the person concerned. In assessing the burden for an individual, a person enjoying the special confidence of the person concerned shall assess the burden where appropriate.

text: Article 17 – Research with minimal risk and minimal burden

text: CHAPTER VI – Specific situations

text: the research has the aim of contributing to the ultimate attainment of results capable of conferring benefit to other women in relation to reproduction or to other embryos, foetuses or children;

text: Research on a pregnant woman which does not have the potential to produce results of direct benefit to her health, or to that of her embryo, foetus or child after birth, may only be undertaken if the following additional conditions are met:

text: ii research of comparable effectiveness cannot be carried out on women who are not pregnant;

text: iii the research entails only minimal risk and minimal burden.

text: Where research is undertaken on a breastfeeding woman, particular care shall be taken to avoid any adverse impact on the health of the child.

text: Article 18 – Research during pregnancy or breastfeeding

text: a person is not in a state to give consent, and

text: The law shall determine whether, and under which protective additional conditions, research in emergency situations may take place when:

text: ii because of the urgency of the situation, it is impossible to obtain in a sufficiently timely manner, authorisation from his or her representative or an authority or a person or body which would in the absence of an emergency situation be called upon to give authorisation.

text: research of comparable effectiveness cannot be carried out on persons in nonemergency situations;

text: The law shall include the following specific conditions:

text: ii the research project may only be undertaken if it has been approved specifically for emergency situations by the competent body;

text: iii any relevant previously expressed objections of the person known to the researcher shall be respected;

text: iv where the research has not the potential to produce results of direct benefit to the health of the person concerned, it has the aim of contributing, through significant improvement in the scientific understanding of the individual's condition, disease or disorder, to the ultimate attainment of results capable of conferring benefit to the person concerned or to other persons in the same category or afflicted with the same disease or disorder or having the same condition, and entails only minimal risk and minimal burden.

text: Persons participating in the emergency research project or, if applicable, their representatives shall be provided with all the relevant information concerning their participation in the research project as soon as possible. Consent or authorisation for continued participation shall be requested as soon as reasonably possible.

text: Article 19 – Research on persons in emergency clinical situations

text: Where the law allows research on persons deprived of liberty, such persons may participate in a research project in which the results do not have the potential to produce direct benefit to their health only if the following additional conditions are met:

text: research of comparable effectiveness cannot be carried out without the participation of persons deprived of liberty;

text: ii the research has the aim of contributing to the ultimate attainment of results capable of conferring benefit to persons deprived of liberty;

text: Article 20 – Research on persons deprived of liberty

text: CHAPTER VII – Safety and supervision

text: All reasonable measures shall be taken to ensure safety and to minimise risk and burden for the research participants.

text: Research may only be carried out under the supervision of a clinical professional who possesses the necessary qualifications and experience.

text: Article 21 – Minimisation of risk and burden

text: The researcher shall take all necessary steps to assess the state of health of human beings prior to their inclusion in research, to ensure that those at increased risk in relation to participation in a specific project be excluded.

text: Where research is undertaken on persons in the reproductive stage of their lives, particular consideration shall be given to the possible adverse impact on a current or future pregnancy and the health of an embryo, foetus or child.

text: Article 22 – Assessment of health status

text: Research shall not delay nor deprive participants of medically necessary preventive, diagnostic or therapeutic procedures.

text: In research associated with prevention, diagnosis or treatment, participants assigned to control groups shall be assured of proven methods of prevention, diagnosis or treatment.

text: The use of placebo is permissible where there are no methods of proven effectiveness, or where withdrawal or withholding of such methods does not present an unacceptable risk or burden.

text: Article 23 – Non-interference with necessary clinical interventions

text: Parties to this Protocol shall take measures to ensure that the research project is re-examined if this is justified in the light of scientific developments or events arising in the course of the research.

text: the research needs to be discontinued or if changes to the research project are necessary for the research to continue;

text: The purpose of the re-examination is to establish whether:

text: ii research participants, or if applicable their representatives, need to be informed of the developments or events;

text: iii additional consent or authorisation for participation is required.

text: Any new information relevant to their participation shall be conveyed to the research participants, or, if applicable, to their representatives, in a timely manner.

text: The competent body shall be informed of the reasons for any premature termination of a research project.

text: Article 24 – New developments

text: CHAPTER VIII – Confidentiality and right to information

text: Any information of a personal nature collected during biomedical research shall be considered as confidential and treated according to the rules relating to the protection of private life.

text: The law shall protect against inappropriate disclosure of any other information related to a research project that has been submitted to an ethics committee in compliance with this Protocol.

text: Article 25 – Confidentiality

text: Research participants shall be entitled to know any information collected on their health in conformity with the provisions of

text: Article 10

text: of the Convention.

text: Other personal information collected for a research project will be accessible to them in conformity with the law on the protection of individuals with regard to processing of personal data.

text: Article 26 – Right to information

text: If research gives rise to information of relevance to the current or future health or quality of life of research participants, this information must be offered to them. That shall be done within a framework of health care or counselling. In communication of such information, due care must be taken in order to protect confidentiality and to respect any wish of a participant not to receive such information.

text: Article 27 – Duty of care

text: On completion of the research, a report or summary shall be submitted to the ethics committee or the competent body. 2 The conclusions of the research shall be made available to participants in reasonable time, on request. 3 The researcher shall take appropriate measures to make public the results of research in reasonable time.

text: Article 28 – Availability of results

text: CHAPTER IX – Research in States not parties to this Protocol

text: Sponsors or researchers within the jurisdiction of a Party to this Protocol that plan to undertake or direct a research project in a State not party to this Protocol shall ensure that, without prejudice to the provisions applicable in that State, the research project complies with the principles on which the provisions of this Protocol are based. Where necessary, the Party shall take appropriate measures to that end.

text: Article 29 – Research in States not parties to this Protocol

text: CHAPTER X – Infringement of the provisions of the Protocol

text: The Parties shall provide appropriate judicial protection to prevent or to put a stop to an unlawful infringement of the rights or principles set forth in this Protocol at short notice.

text: Article 30 – Infringement of the rights or principles

text: The person who has suffered damage as a result of participation in research shall be entitled to fair compensation according to the conditions and procedures prescribed by law.

text: Article 31 – Compensation for damage

text: Parties shall provide for appropriate sanctions to be applied in the event of infringement of the provisions contained in this Protocol.

text: Article 32 – Sanctions

text: CHAPTER XI – Relation between this Protocol and other provisions and re-examination of the Protocol

text: As between the Parties, the provisions of

text: Articles 1

text: to 32 of this Protocol shall be regarded as additional articles to the Convention, and all the provisions of the Convention shall apply accordingly.

text: Article 33 – Relation between this Protocol and the Convention

text: None of the provisions of this Protocol shall be interpreted as limiting or otherwise affecting the possibility for a Party to grant research participants a wider measure of protection than is stipulated in this Protocol.

text: Article 34 – Wider protection

text: In order to monitor scientific developments, the present Protocol shall be examined within the Committee referred to in

text: Article 32

text: of the Convention no later than five years from the entry into force of this Protocol and thereafter at such intervals as the Committee may determine.

text: Article 35 – Re-examination of the Protocol

text: CHAPTER XII – Final clauses

text: This Protocol shall be open for signature by Signatories to the Convention. It is subject to ratification, acceptance or approval. A Signatory may not ratify, accept or approve this Protocol unless it has previously or simultaneously ratified, accepted or approved the Convention. Instruments of ratification, acceptance or approval shall be deposited with the Secretary General of the Council of Europe.

text: Article 36 – Signature and ratification

text: This Protocol shall enter into force on the first day of the month following the expiration of a period of three months after the date on which five States, including at least four member States of the Council of Europe, have expressed their consent to be bound by the Protocol in accordance with the provisions of

text: Article 36

text: In respect of any Signatory which subsequently expresses its consent to be bound by it, the Protocol shall enter into force on the first day of the month following the expiration of a period of three months after the date of the deposit of the instrument of ratification, acceptance or approval.

text: Article 37 – Entry into force

text: After the entry into force of this Protocol, any State which has acceded to the Convention may also accede to this Protocol.

text: Accession shall be effected by the deposit with the Secretary General of the Council of Europe of an instrument of accession which shall take effect on the first day of the month following the expiration of a period of three months after the date of its deposit.

text: Article 38 – Accession

text: Any Party may at any time denounce this Protocol by means of a notification addressed to the Secretary General of the Council of Europe.

text: Such denunciation shall become effective on the first day of the month following the expiration of a period of three months after the date of receipt of such notification by the Secretary General.

text: Article 39 – Denunciation

text: The Secretary General of the Council of Europe shall notify the member States of the Council of Europe, the European Community, any Signatory, any Party and any other State which has been invited to accede to the Protocol of:

text: any signature;

text: the deposit of any instrument of ratification, acceptance, approval or accession;

text: any date of entry into force of this Protocol in accordance with

text: Articles 37

text: and 38;

text: any other act, notification or communication relating to this Protocol.

text: In witness whereof the undersigned, being duly authorised thereto, have signed this Protocol.

text: Done at Strasbourg, this 25th day of January 2005, in English and in French, both texts being equally authentic, in a single copy which shall be deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe shall transmit certified copies to each member State of the Council of Europe, to the non-member States which have participated in the elaboration of this Protocol, to any State invited to accede to the Convention and to the European Community.

text: Article 40 – Notifications