belgiquelex.be - Carrefour Bank of Legislation

7 FEBRUARY 2014. - An Act to provide a variety of accessibility provisions for health care

PHILIPPE, King of the Belgians,
To all, present and to come, Hi.
The Chambers adopted and We sanction the following:
CHAPTER 1^er. - General provision
Article 1^er. This Act regulates a matter referred to in Article 78 of the Constitution.
CHAPTER 2. - Amendments to the Compulsory Health Care and Compensation Insurance Act, coordinated on 14 July 1994
Section 1^re. - Medical needs not met
Art. 2. In section 16 of the Compulsory Health Care Insurance Act, coordinated on 14 July 1994, last amended by the Act of 19 May 2010, the following amendments are made:
1° § 1^erParagraph 1^er, 5°, is restored in the following wording:
"5° sets the amounts allocated to the Special Solidarity Fund. ";
2° in § 3, the words ", 5°" are inserted between the words "4°" and the words "and 7°".
Art. 3. In section 25 of the Act, replaced by the Act of 27 April 2005 and amended by the Acts of 26 March 2007 and 10 December 2009, the following amendments are made:
1° in paragraph 1^er, the words "is fixed, for each calendar year, by royal decree deliberated in the Council of Ministers" are replaced by the words "as well as the part of it that is allocated to the interventions granted under Article 25quater/1, § 2, are fixed, for each calendar year, by the General Council";
2° paragraph 2 is supplemented by the words "and respecting the allocation made by the General Council";
3° in paragraph 3, the words ", and as long as they are actually liable for the amounts requested" are inserted between the words "individual or collective" and the words ". The Fund
4° the article is supplemented by four paragraphs written as follows:
"If the Drug Refund Commission, the Invasive Implants and Medical Devices Refund Board or the relevant Technical Council has already formulated a proposal on reimbursement that may be granted or if the Minister has made a negative decision, the College of Physicians-Directors may not grant a higher response to the reimbursement proposed by the Drug Refund Commission, the Invasive Implants and Medical Devices Refund Board or the relevant Technical Council.
To determine the portion of the payment allocation resulting from individual decisions based on cohort decisions referred to in section 25quater/1, § 1^er, the General Council, on the advice of the Commission referred to in section 25octies/1 and of the College of Physicians-Directors, draws a list of unmeted medical needs for year T for October 31 of the year T-1 after a review of the economic and medical impact.
Applications for registration on the list of unmet medical needs are filed on May 15 of the T-1 year by the Minister who has Public Health in his or her duties, the Minister who has Social Affairs in his or her duties or a firm. The Commission referred to in section 25octies/1 and the College of Physicians and Directors may, in their notices, propose listing other unmet medical needs.
By derogation from paragraphs 2 and 3, the interventions resulting from a cohort decision are granted to the person who has financially taken charge of making the drug available to the recipient. "
Art. 4. Article 25ter, § 1^erParagraph 3 of the Act, inserted by the Act of 27 April 2005, is repealed.
Art. 5. In the same Act, an article 25quater/1 is inserted as follows:
"Art. 25quater/1. § 1^er. The College of Physicians and Directors may, on a proposal by the Commission referred to in section 25octies/1 and under the conditions set out in this paragraph, adopt a cohort decision that determines the cost of drugs as defined in section 1^er§ 1^er(1), (a), and (2), of the Act of 25 March 1964 on Drugs.
The cohort decision is a limited policy decision in time based on available economic and medical data.
The drugs covered by a cohort decision that sets inclusion criteria meet an unmet medical need and each of the following conditions:
(a) the drug is administered to treat a serious illness or illness that is considered to endanger life;
(b) the drug does not have any scientifically acceptable alternative treatment in the context of compulsory health care insurance;
(c) the drug is the subject of a compassionate program or an emergency medical program established by the Minister with Public Health in his or her duties or delegate;
(d) the drug meets a medical need identified on the list of unmet medical needs referred to in section 25.
If the compassionate program or emergency medical program that allowed the adoption of the cohort decision ended for the relevant indications following an authorization to market a drug, the cohort decision for the relevant indications may continue to produce its effects or be renewed until a decision on the reimbursement of the relevant indications has been adopted.
The drug for which a firm has filed an application on the basis of this paragraph shall not be subject to an application for market authorization following one of the procedures referred to in section 34, paragraph 1^er, 5°, c), 2), or a reimbursement procedure that arises from these procedures.
By derogation from paragraph 3, (d), a drug that responds to an unmet medical need and for which it was not possible to introduce an application for registration on the list on May 15 of the year T-1 may be subject to a cohort decision if the General Council authorized it after notice of the Commission referred to in section 25octies/1 and the College of Physicians-Directors.
§ 2. When the College of Physicians and Directors has adopted a cohort decision that sets inclusion criteria in accordance with § 1^er and section 25octies/2, it grants, under the conditions set out in this paragraph and in its cohort decision, interventions in the cost of drugs as defined in section 1^er§ 1^er(1), (a), and (2), of the Act of 25 March 1964 on Drugs if each of the following conditions is met:
(a) the drug is administered to treat a serious illness or illness that is considered to endanger life;
(b) the drug is prescribed to a named beneficiary who does not participate in a clinical trial within the meaning of the Human Person Experiments Act of 7 May 2004 for that drug, and is likely to have a significant benefit for him after examination of his side effects and toxicity;
(c) the medication is prescribed by a medical practitioner, specialized in the treatment of the affected condition, legally authorized to practise medicine in a Member State of the European Union or a State belonging to the European Economic Area.
The College may, if applicable, request a complementary advice from a medical practitioner who is specialized in the treatment of the affected condition and legally authorized to practise medicine in Belgium.
The College of Physicians/Directors may, in its cohort decision, assign to the consulting physician the authority to make individual decisions for applications that fall within the scope of the cohort decision that sets inclusion criteria and meets the conditions set out in paragraph 1^er.
The cohort decision setting inclusion criteria refers to the intervention granted. It also provides the terms and conditions for payment of this intervention and the recipient of these payments.
For firms, interventions only cover the packagings that were delivered to the recipient after the adoption of the cohort decision.
§ 3. When the College of Physicians and Directors has adopted a cohort decision that sets out exclusion criteria, it refuses interventions in the cost of the drug as defined in section 1^er§ 1^er, 1), (a), and 2), of the Act of March 25, 1964 for individual applications filed under sections 25 to 25 novelties that meet the exclusion criteria set out in the cohort decision unless the intervention can be granted under section 25quinquies.
If the College of Physicians and Directors, after reviewing the criteria set out in section 25quinquies, § 2, expressly mentions in the cohort decision that sets out the exclusion criteria that section 25quinquies cannot be applied for individual applications that meet the exclusion criteria, it refuses interventions in the cost of the drug as defined in section 1^er§ 1^er(1), (a), and (2), of the Act of March 25, 1964 for individual applications filed under sections 25 to 25novies that meet the exclusion criteria.
§ 4. Individual applications that do not meet the inclusion criteria or the exclusion criteria set out in a cohort decision are considered individually under the criteria set out in sections 25bis to 25sexies.
§ 5. The King determines the terms and conditions under which a request for a cohort decision may be filed as well as the terms and conditions under which the College of Physicians and Directors may adopt a cohort decision on the Commission's proposal under section 25octies/1. "
Art. 6. In section 25septies of the Act, inserted by the Act of 27 April 2005 and amended by the Act of 13 December 2006, the following amendments are made:
(a) § 1^er, paragraph 3, is supplemented by the following sentence:
"For beneficiaries who are covered under Article 25quater/1, § 2, the application is filed by the doctor who prescribed the medication in accordance with Article 25quater/1, § 2, paragraph 1^er, c), in the proceedings and in accordance with the terms provided by the King by order deliberately in the Council of Ministers and the declaration on the honour provided for in paragraph 4, 4°, is not required. ";
(b) § 1^er, paragraph 4, 1°, is replaced by the following:
"1° a dated information sheet, the model of which is established by the Insurance Committee, on the proposal of the College of Physicians and Directors, and submitted by the physician-advisor of the insurer body to the College of Physicians and Directors, within thirty days of the day on which the recipient introduced the application; ";
(c) § 1^er, paragraph 4, 2°, is replaced by the following:
"4° the statement on honour of which the model is established by the Insurance Committee, on the proposal of the College of Physicians and Directors in which the recipient:
- certifies, with regard to the benefits for which he requests an intervention, that he has exhausted his rights under Belgian or foreign legislation and that he cannot claim rights under an individual or collective contract;
- discloses the amount to which it may, if any, assert its rights under the aforementioned contract;
- attests to having been informed that the issuance of an authorization to receive treatment abroad by its insurer does not open the right to an intervention of the Special Solidarity Fund;
- determines whether or not the reimbursements provided by health care insurance under the Special Solidarity Fund will be paid; ";
(d) § 1^er, paragraph 4, is supplemented by the 5° and 6° as follows:
"5° a copy signed by the beneficiary, his legal representative or the trusted person referred to in the Act of 22 August 2002 on the rights of the patient of his or her written consent on a document that contains information in accordance with article 8, paragraph 2, of the above-mentioned Act and, where applicable, information relating to the data collected by the prescribing physician and registered to assess the relevance of the interventions;
6° for imported medicines, the ex-factory price in the country of which they are imported. ";
(e) § 1^er is supplemented by a paragraph that reads as follows:
"Any request for additional information sent directly to the recipient suspends the 30-day period. The same is true when the recipient is informed that additional information has been requested. ";
(f) § 2, fifth dash, is replaced by the following:
"- an application for an orphan drug refundable in the indication concerned for the target group to which the patient belongs and which has not yet been examined under Belgian law. ";
(g) § 2 is supplemented by the sixth dash written as follows:
"- an application for a drug subject to a cohort decision that sets out exclusion criteria for a patient who meets these exclusion criteria unless the patient is under 19 years of age and if the cohort decision that sets exclusion criteria does not exclude the application of section 25quinquies. ".
Art. 7. In section 25octies, paragraph 2, of the same Act, inserted by the Act of 27 April 2005, the words "in particular the Commission referred to in section 25octies/1" are inserted between the words "in the INAMI" and the words "in the Federal Public Service".
Art. 8. In the same Act, an article 25octies/1 is inserted as follows:
"Art. 25octies/1. § 1^er. The Institute shall establish a Board of Notice in the event of a temporary intervention for the use of a drug, as referred to in the Commission.
The Commission:
1° provides advice on unmet medical needs;
2° makes proposals for intervention in the cost of medicines for cohorts of patients in accordance with Article 25 quater/1, § 1^er;
3° responds to requests for advice submitted by the College of Physicians and Directors as part of individual requests for intervention.
§ 2. The Commission is composed of:
1° of two members representing insurers;
2° of two designated members within the Federal Agency for Drugs and Health Products;
3° of two members appointed on the proposal of the Drug Refund Commission, one of the representatives of the insurance organizations that sit in the other being the Chairman of the Drug Refund Commission, or one of the experts working in a university institution;
4° of the Chairperson of the Commission on Human Drugs;
5° of the Chair of the College of Physicians for Orphan Drugs;
6° of two staff of the Institute;
7° of a staff member of the Federal Agency for Drugs and Health Products;
8° of a representative of professional associations representative of the drug industry.
The member referred to in paragraph 1^er, 8°, has advisory voice.
The King sets the rules for the designation of members of the Commission and its functioning.
In order to make proposals for cohorts of patients, the Commission encloses ad hoc experts on the basis of the application. These ad hoc experts have a consultative voice and are not members of the Commission.
§ 3. The Commission’s proposals referred to in § 1^er, paragraph 2, 2°, are issued on initiative or at the request of the Minister who has Public Health in his or her powers, the Minister who has Social Affairs in his or her duties, the College of Physicians and Directors or a firm.
Art. 9. In the same law, an article 25octies/2 is inserted as follows:
"Art. 25octies/2. § 1^er. A firm may only apply for a cohort decision if it is not yet possible to introduce an application to amend the list of refundable pharmaceutical specialties for the indication concerned.
Without prejudice to obligations arising from other legislation, the firm, as part of its application:
1° undertakes to carry out the clinical trials of which it is responsible for the indication concerned by its application;
2° undertakes, if not already done, to file an application for a marketing authorization for the indications concerned by its application within a period not exceeding six months from the date of its application and to communicate the time limit within which it will effectively introduce the application;
3° undertakes to file a refund request for the information concerned by its application within a period not exceeding six months from the date on which it has received a marketing authorization and to communicate the time limit within which it will effectively introduce this application;
4° undertakes to take charge of the cost of the drug for recipients who apply for an individual application and who fall within the definition of the cohort that is resumed in their application from the day of publication of their cohort application and until a cohort decision is adopted as long as the drug still provides therapeutic benefit to the recipient;
5° undertakes to continue to take charge of the cost of the drug for recipients who have introduced an individual application between the day of the introduction of the cohort application and the day of the adoption of the cohort decision and who are subject to the definition of the recovery cohort in its application and for recipients who have received a favourable decision during the duration of the cohort if they are not or more taken up in a cohort decision, and
6° guarantees the availability of the medication.
The cohort referred to in the firm's application is published on the Institute's website on the day of the receipt of a full application.
§ 2. The College of Physicians-Directors may accept or refuse the Commission's proposals but may not alter their content.
§ 3. If the application for intervention in the cost of medicines for cohorts of patients emanates from the firm, the firm may at the time of its initial application or not later than seven days after the Commission's proposal was received, propose to enter into a convention with the Institute that determines the terms and conditions of the cohort decision.
The Commission at the time it formulates its proposal for cohorts of patients may propose the conclusion of a convention with the Institute, which determines the terms of the cohort decision.
The King sets out by order deliberately in the Council of Ministers the conditions and rules that such a convention may be concluded between the firm and the Institute and the consequences of a negotiation on the period in which the College makes its decision and the maintenance of the firm's commitments under paragraph 1^er.
§ 4. If the College of Physicians and Directors decides to reject the Commission's proposal, no cohort decision is adopted and the College retains the opportunity to make individual decisions.
If the College decides to follow the Commission's proposal or confirms an agreement concluded, the College shall adopt a cohort decision whose validity is established within the limits set by the King. The cohort and the inclusion or exclusion criteria are published on the Institute's website. At the same time, the publication relating to the cohort application is archived so that the fact that it no longer produces effects appears clearly.
If no cohort decision is adopted within 75 days of the date of the sending of the acknowledgement of receipt attesting that the application is complete, possibly increased from the suspensions resulting from the negotiation of a convention, the firm is released from the commitments set out in § 1^er for the future but continues to take care of patients who have been the subject of an individual decision as long as the drug still provides therapeutic benefit to the recipient. The publication on the cohort application is archived so that the fact that it no longer produces effects is clearly apparent.
The College of Physicians and Directors is bound by the cohort decisions it has taken. It cannot be derogated from in the treatment of individual requests that enter the scope of the cohort decision. ".
Art. 10. In section 25 of the Act, inserted by the Act of 27 April 2005, the following amendments are made:
1° the word "25nonies" is replaced by the word "25novies";
2° Paragraph 3 is replaced by the following:
"By derogation from paragraphs 1^er and 2, payments resulting from individual decisions based on cohort decisions referred to in Article 25quater/1, § 1^er, are performed by the Institute and paid directly to the firm.
The decision of the College of Physicians-Directors is notified to the recipient within 15 working days of the receipt of the notification of the College of Physicians-Directors' decision by the insurer. The Institute retains a copy of the notification to the recipient.
The King may foresee derogations from the preceding paragraph for individual decisions that execute a cohort decision referred to in section 25quater/1, § 1^er"
Art. 11. In article 69, § 5, of the same law, as amended by the laws of 10 August 2001 and 22 December 2003, the following amendments are made:
1° in paragraph 1^er, the words "5°, (b) and (c)" are replaced by the words "paragraph 1^er5°, b), c) and e)";
2° in the same paragraph, the word "representative" is repealed;
3° in paragraph 2, the words "5°, (b) and (c)" are replaced by the words "5°, (b), (c) and (e)";
4° in the same paragraph, the word "preced" is replaced by the word "1^er".
Art. 12. This section comes into force on a date to be determined by the King.
Article 2 and Article 3, 1 and 2 are effective the day after the publication of this Act to the Belgian Monitor.
If this section comes into force between March 15 and May 15, applications for registration on the list of unpaid medical needs may be filed within three months of the first day of the month following the entry into force of this section and no later than August 31 of the calendar year of entry into force (Y T-1).
If this section comes into force after May 15, cohort decisions may be adopted during the calendar year following the calendar year of the coming into force (Y T), without the medical need covered being included in the list of non-reported medical needs and without authorization from the General Council. These cohort decisions end December 31 of the following year (T+1 year). Medical needs encountered by cohort decisions adopted during T-Year will be taken into account in the list of non-reported medical needs established during T-Year for T+1.
Section 2. - The majored intervention
Art. 13. In section 37, § 19, of the Compulsory Health Care and Compensation Insurance Act, coordinated on 14 July 1994, replaced by the Act of 29 March 2012, the following amendments are made:
1° in paragraph 1^er, second and third sentences, the word "spouse" is each time replaced by the words "unseparated spouse of fact or body and property";
2° paragraph 1^er is supplemented by the following sentence:
"The King may, however, provide that the household is constituted differently in the cases referred to in paragraph 9 and when a child is registered as a holder. ";
3° in paragraph 7, the words "divorce or separation if the spouse retains the quality of the dependant of the spouse" are repealed.
Art. 14. Section 13 comes into force on 1^er January 2014.
Section 3. - Advertising.
Art. 15. In section 218 of the Compulsory Health Care Insurance Act, coordinated on 14 July 1994, § 2 is replaced by the following:
"§2. The Institute makes available to the public, on its website, the list of caregivers with a number assigned by the Institute. This list includes names, names, INAMI number and status of accession to agreements and conventions.
Insurance organizations are also required to bring the information referred to in paragraph 1^er which are transmitted to them by the Institute to the knowledge of the beneficiaries. ".
Art. 16. Section 15 comes into force on 1^er January 2014.
Section 4. - Drugs
Art. 17. In section 35bis of the Compulsory Health Care Insurance Act, coordinated on 14 July 1994, inserted by the Act of 10 August 2001 and last amended by the Act of 22 June 2012, the following amendments are made:
1° § 2, paragraph 3, is replaced by the following:
"The decision is communicated by a notification to the applicant and published on the Institute's website, either by the Minister or by officials mandated by him. The amendment of the list comes into force on the date fixed by the Ministerial Order. ";
2° in the Dutch text of § 4, paragraph 9, the words "artikel 5" are replaced by the words "het vijfde lid";
3° § 5, paragraph 2, is replaced by the following:
"In the event of a decline in the price and/or the refund base, the change in the list comes into force on the date fixed by the ministerial order."
Art. 18. In section 35ter of the Act, replaced by the Act of 27 December 2005 and last amended by the Act of 30 July 2013, the following amendments are made:
1° in paragraph 2, paragraph 3, the words "monthly and" are repealed;
2° in paragraph 2bis, paragraph 3, the words "monthly and" are repealed;
3° in paragraph 3, paragraph 3, the words "monthly and" are repealed.
Art. 19. This section comes into force on a date to be determined by the King.
Section 5. - Special Solidarity Fund
Art. 20. In section 25bis, paragraph 2, (e), of the Compulsory Health Care Insurance Act, coordinated on 14 July 1994, inserted by the Act of 27 April 2005, the following amendments are made:
1° the word "slightly" is inserted between the words "authorized" and "to practice";
2° the words "in Belgium" are replaced by the words "in a Member State of the European Union or a State belonging to the European Economic Area";
3° the provision is supplemented by the following sentence:
"The College of Physicians-Directors may, if applicable, request a complementary opinion from a specialist physician who is specialized in the treatment of the affected condition and authorized to practise medicine in Belgium. ".
Art. 21. In section 25ter of the Act, inserted by the Act of 27 April 2005, the following amendments are made:
(a) to § 1^er(e), the following amendments are made:
1° the word "slightly" is inserted between the words "authorized" and "to practice";
2° the words "in Belgium" are replaced by the words "in a Member State of the European Union or a State belonging to the European Economic Area";
3° the provision is supplemented by the following sentence:
"The College of Physicians-Directors may, if applicable, request a complementary opinion from a specialist physician who is specialized in the treatment of the affected condition and authorized to practise medicine in Belgium. ";
(b) in paragraph 2, subparagraph 2 (d), the following amendments are made:
1° the word "legally" is inserted between the words "authorized" and "to be practiced;
2° the words "in Belgium" are replaced by the words "in a Member State of the European Union or a State belonging to the European Economic Area";
3° the provision is supplemented by the following sentence:
"The College of Physicians-Directors may, if applicable, request a complementary opinion from a specialist physician who is specialized in the treatment of the affected condition and authorized to practise medicine in Belgium. ".
Art. 22. In section 25quater, paragraph 2, (e), of the Act, inserted by the Act of 27 April 2005, the following amendments are made:
1° the word "slightly" is inserted between the words "authorized" and "to practice";
2° the words "in Belgium" are replaced by the words "a Member State of the European Union or a State belonging to the European Economic Area";
3° the provision is supplemented by the following sentence:
"The Colleges of Physicians-Directors may, if applicable, request a complementary opinion from a specialist physician who is specialized in the treatment of the affected condition and authorized to practice medicine in Belgium. ".
Art. 23. In Article 25quinquies, § 2(c), of the same law, inserted by the law of 27 April 2005, the following amendments are made:
1° the word "slightly" is inserted between the words "authorized" and "to practice";
2° the words "in Belgium" are replaced by the words "a Member State of the European Union or a State belonging to the European Economic Area";
3° the provision is supplemented by the following sentence:
"The College of Physicians-Directors may, if applicable, request a complementary opinion from a specialist physician who is specialized in the treatment of the affected condition and authorized to practise medicine in Belgium. ".
Art. 24. Section 25Sexies of the Act, inserted by the Act of 27 April 2005, is replaced by the following:
§ 1^er. The Special Solidarity Fund may grant a financial intervention for health benefits provided abroad, provided that the application meets each of the following conditions:
1° the case is worth interest. The case is of interest to the extent that it is consistent with each of the following conditions:
(a) health services provided abroad are expensive;
(b) health services provided abroad are of scientific value and effectiveness widely recognized by authoritative international medical authorities;
(c) health services provided abroad are no longer an experimental stage;
(d) the health benefits provided abroad are for the treatment of a condition that affects the vital functions of the recipient;
(e) there is no acceptable therapeutic alternative in terms of diagnosis or therapy that can be delivered to Belgium within a reasonable medical period taking into account the health status of the recipient at the time of the application;
(f) the health benefits provided abroad have been, prior to receiving care, prescribed by a medical practitioner, specialized in the treatment of the affected condition and legally authorized to practise medicine in a Member State of the European Union or the European Economic Area. The College of Physicians-Directors may, if applicable, request a further advice from a physician-specialist, specialized in the treatment of the affected condition and authorized to practise medicine in Belgium.
2° the College of Physicians and Directors has given pre-authorisation to obtain care for these health benefits provided abroad.
§ 2. The Special Solidarity Fund may grant a financial intervention for the travel and residence expenses of the recipient for health benefits provided abroad, provided that the application meets each of the following conditions:
1° the case is of interest within the meaning of § 1^er, 1° ;
2° the location of the treatment is beyond a distance of 350 km calculated on the fly and from the centre of Brussels, regardless of the place of residence of the beneficiary. However, if a reasoned medical report pre-displaces, that due to the particularly severe health condition of the beneficiary, medical transport is absolutely required, the College may grant for travel an intervention calculated in accordance with the terms set by the King, even for travel within a distance of less than 350 km;
3° a prior authorization, if applicable, was issued in accordance with the Belgian, international or supranational regulations in force for health services provided abroad;
4° the College of Physicians-Directors has given prior authorization to grant a financial intervention for the travel and stay expenses of the beneficiary for health benefits provided abroad.
§ 3. The Special Solidarity Fund may grant a financial intervention for the travel and living expenses of the person accompanying the recipient for health benefits provided abroad in accordance with the conditions listed in § 1^er1°, under the following conditions.
1° the beneficiary is under the age of 19 years; either the beneficiary is 19 years of age or older, and the support is essential for medical reasons, and this is essential in a properly substantiated medical report;
2° the College of Physicians-Directors has given prior authorization to obtain care to grant a financial intervention in the travel and stay expenses of the beneficiary in respect of health benefits provided abroad;
3° the College of Physicians-Directors has given prior authorization to obtain care to grant a financial intervention in the travel and stay expenses of the accompanying person relating to health benefits provided abroad. ".
Section 6. - The intervention of health care insurance for special models of health care dispensation or payment
Art. 25. In Article 56, § 2, paragraph 1^er, 3°, of the same law, replaced by the law of 10 August 2001, the words "or moral persons" are inserted between the words "to care providers" and the words "that develop".
CHAPTER 3. - Amendments to the Act of 13 June 1986
on organ removal and transfer
Art. 26. Article 1^erter of the Act of 13 June 1986 on organ removal and transplantation, inserted by the Act of 3 July 2012, is supplemented by the 16th drafted as follows:
"16° "delegated body": an organization to which tasks were delegated in accordance with Article 17, paragraph 1^er, Directive 2010/53/EU of the European Parliament and Council of 7 July 2010 on standards of quality and safety of human organs for transplantation or a European organization for the exchange of bodies to which tasks were delegated in accordance with Article 21 of the aforementioned Directive 2010/53/EU. ".
Art. 27. In article 8, § 2, of the same law, the words "the person or persons required to consent" are replaced by the words "the donor".
Art. 28. In section 9, paragraph 2, of the Act, the words "and, if any, persons whose consent is required" are repealed.
Art. 29. In section 13bis of the Act, replaced by the Act of July 3, 2012, the following amendments are made:
1° § 1^erParagraph 1^er, is completed by the 4th written as follows:
"4° the holding and management of the information collected for the characterization of the organs taken and donors. ";
2° § 3 is replaced by the following:
§ 3. The King may specify the missions assigned to the European organization for the exchange of bodies, in particular with regard to the establishment of information procedures for the exchange of information as referred to in § 1^erParagraph 1^er, 1°, 2° and 4°, with competent authorities or delegated bodies of the Member States of the European Union, with obtaining bodies or transplant centres, as well as for the registration and availability of the aforementioned information. The exchange, registration and availability of information referred to above are intended to achieve a high level of public health during the exchange of bodies within the European Union.
The information referred to in paragraph 1^er data collected pursuant to this Act and its enforcement orders in respect of characterization, traceability, incidents and serious adverse reactions. ".
Art. 30. In section 17 of the Act, as amended by the Acts of 25 February 2007 and 3 July 2012, the following amendments are made:
1° in § 2, the words "Article 14" are replaced by the words "Article 4bis" and the words "Article 1^er§ 3 are replaced by the words "Article 1^erbis, § 1
2° in § 3, paragraph 1, the words "articles 4 to 11 and 13 and articles 13ter and 13quater" are replaced by the words "articles 4, 5 to 11, 13, 13ter and 13quater".
CHAPTER 4. - Amendments to the coordinated law of 10 July 2008
hospitals and other health-care facilities
Art. 31. In title I^er of the Coordinated Act of 10 July 2008 on Hospitals and Other Care Institutions, a Chapter VII entitled "Communication of Information by the Hospital".
Art. 32. In Chapter VII, inserted by Article 31, an article 30/2 is inserted as follows:
"Art. 30/2. § 1^er. The hospital has a website providing general information.
The above-mentioned general information contains at least:
1° the provision of care, i.e. services, medical and medical-technical services, hospital functions, health care programs available to the hospital;
2° the information resumed in section 98 and its enforcement orders.
The hospital's website contains a reference to the information provided for in section 218, § 2, of the Compulsory Health Care and Compensation Insurance Act, coordinated on 14 July 1994, provided by the National Institute of Health and Disability Insurance.
§ 2. General information referred to in § 1^er, paragraph 2, 2°, also mentions in particular the person or service in the hospital to which personalized information and explanations can be obtained on the subjects mentioned in § 1^er, paragraph 2, 2°, indicating the address, email address and telephone number of the contact point. The personalized information referred to above may be requested before, during or after hospitalization.
§ 3. The King may specify the rules and procedures for the communication of information referred to in this Article. ".
Art. 33. In section 152 of the Act, replaced by the Act of 27 December 2012, § 6 is repealed.
Art. 34. Chapter 4 comes into force on 1^er July 2014.
Promulgation of this law, let us order that it be clothed with the seal of the State and published by the Belgian Monitor.
Given in Brussels on 7 February 2014.
PHILIPPE
By the King:
Minister of Social Affairs and Public Health,
Ms. L. ONKELINX
Seal of the state seal:
The Minister of Justice,
Ms. A. TURTELBOOM
____
Note
House of Representatives (www.lachambre.be):
Documents: 2013/2014-0 - 53-3260
Full report: 23 January 2014