Act Miscellaneous Provisions Urgent Health (1)

Original Language Title: Loi portant des dispositions diverses urgentes en matière de santé (1)

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Posted the: 2012-02-17 Numac: 2012022064 SERVICE PUBLIC FEDERAL security social 17 February 2012. -Law concerning various provisions urgent health (1) ALBERT II, King of the Belgians, to all, present and to come, hi.
The Chambers have adopted and we endorse the following: Chapter 1. -Disposition introductory Article 1. This Act regulates a matter referred to in article 78 of the Constitution.
CHAPTER 2. -Amendments to the law on compulsory health care and benefits, insurance co-ordinated on 14 July 1994 Section 1st. -Measures relating to medicinal arts.
2A article 35A of the Act on compulsory insurance health care and benefits, co-ordinated on 14 July 1994, inserted by the law of 10 August 2001 and as amended by the Act of December 23, 2009, the following amendments are made: 1 ° the § 2A, paragraph 3, is supplemented by a 4 °, as follows: "4 ° when the repayment of a specialty database consists of an amount fixed by indication. or treatment or consideration for the drug or drugs that are provided for this indication, this treatment all this review. »;
2 ° in the § 2 bis, paragraph 4, the words 'and 3' shall be replaced by the words ", 3 ° and 4 °";
3 ° § 12 is supplemented by the words"and, by deliberate royal decree in the Council of Ministers, in the cost of proprietary medicinal products for which substitution is authorized in accordance with article 11 of the Decree no royal, 78 of 10 November 1967 on the practice of the professions of health care."
S. 3A article 35b of the Act, replaced by the law of 27 December 2005 and amended by the laws of the April 25, 2007, December 22, 2008, December 10, 2009, 23 December 2009 and December 29, 2010, the following changes are made: 1 ° in the § 1, paragraph 4, the words «of 31 BW» are replaced by the words "of 41 p.c. for specialties for which the intervention of the insurance represents 100 per cent of the basis of reimbursement and 31. BW for other specialties.
2 ° to the § 1, paragraph 6, the words "of 5.5 sq. ft.
additional» are replaced by the words '7 additional BW for specialties for which the intervention of the insurance represents 100 per cent of the basis of reimbursement and 5.5 additional BW for other specialties';
3 ° to § 2, paragraph 1, the words "target reduction to the § 1, paragraph 1 is not applied to the injectable form of the specialties or to the» are replaced by the words" targeted reductions to the § 1 are reduced to half of the targeted percentages to the § 1st for the injectable form of the specialties or for the ';
4 ° to the § 2A, the words "target reduction to the § 1, paragraph 2, is not applied ' are replaced by the words" targeted reductions to the § 1 are reduced to half of the targeted percentages to the § 1»
5 ° it is inserted a § 7, as follows: ' ' § § 7 7 April 1, 2012, targeted reductions in the § 1 are applied, taking into account the provisions of §§ 2 and 2bis, the specialties that fall within the scope of application of this §, for which these reductions have not yet been implemented. » 6 ° it is inserted a § 8, as follows: ' ' § § 8 8 April 1, 2012: a) the basis of reimbursement of specialties for which the intervention of the insurance amounts to 100 per cent of the basis of reimbursement and for which a new basis of reimbursement was fixed after April 1, 2008, on the basis of the provisions of § 1, if necessary by the application of article 35quater, as well as proprietary products referred to in article 34 ((, 1st paragraph, 5 ° c), 2), containing the same active ingredient, is reduced by full right of 14.49 complementary BW;
b) the basis of reimbursement of specialties for which the intervention of the insurance amounts to 100 per cent of the basis of reimbursement and for which a new basis of reimbursement was fixed prior to April 1, 2008, on the basis of the provisions of § 1, if necessary by the application of article 35quater, as well as proprietary products referred to in article 34 ((, 1st paragraph, 5 ° c), 2), containing the same active ingredient, is reduced by full right of 15.84 complementary BW.
»;
7 ° the § 1 is supplemented by a paragraph, as follows: "the reduction referred to in paragraphs 5 and 6 is also applied to products containing the same active ingredient, but to which the provisions of paragraph 1 or 2 are not applied. ''
».
S. 4. at article 37 of the Act, as amended by the law of May 19, 2010, the following changes are made: 1 ° in § 3/2, paragraph 2, the words: "this personal intervention may consist of a fixed amount per indication, processing or examination" shall be replaced by the words "this personal intervention and/or refund may consist of a fixed amount per indication. ', treatment or examination for the medicine or ";
2 ° § 3/2, paragraph 3, is supplemented by the words "In the same way, the King determines by order deliberated in Council of Ministers drug classes which can be the subject of an intervention in the form of a fixed amount per indication, processing or examination.";
3 ° it is inserted a § 3/3, as follows: "§ 3/3. For medicinal products referred to in article 34, paragraph 1, 5 °, a), b) and c), which are provided to recipients who stay in rest and nursing homes and care centres by day, approved by the competent authorities, or in nursing for elderly homes or centers of short stay, approved by the competent authority , or in institutions which, without be approved as rest homes, constitute the home or the common residence of the elderly, and which meet the conditions laid down by the King, the King may lay down special rules for intervention of health care insurance and the personal intervention of the beneficiaries.
For the cost of the above medications, no amount other than the personal intervention by the King can be worn into account to beneficiaries. » Art.
5A section 72 of the Act, replaced by the law of January 25, 1999 and amended by laws of December 24, 1999 and August 10, 2001, the following changes are made: 1 ° in the paragraph 1, the words "to keep within the limits previously set" are replaced by the words ' to master ';
2 ° in paragraph 2, the words 'or not' are inserted after the words "periods in function ';
3 ° in paragraph 3, the words "expected volumes and price adjustments" are replaced by the words 'planned volumes and/or planned adaptations of price';
«4 ° in paragraph 4, the words 'two procedures' are replaced by the words"the following procedures";
5 ° paragraph 4 is supplemented by a 3 ° as follows: «3 ° either on the basis of a request of the company as part of a fall in prices imposed under conditions to be determined by the King.»;
«6 ° in paragraph 5, the words "These proposals" are replaced by the words"the proposals referred to in 1 ° and 2 ° of the preceding paragraph.
S. 6. article 72bis, § 1, of the Act, inserted by the Act of 20 December 1995, replaced by the law of August 10, 2001 and amended by the laws of the December 27, 2006, December 22, 2008 and may 19, 2010, is completed by the 8th, as follows: «8 ° communicate no later than April 1, 2012 and then each time after February 1st and before 1 March of each year. at the Service of health care of the Institute, the ex-factory price in force on 1 January of the year concerned in the Member States of the European Union appointed by the King, on the proposal of the Minister of the economy and the Minister of Social Affairs, for proprietary medicinal products referred to in article 34, paragraph 1, 5 °, b). These data are transmitted immediately by the Institute at the Service of award of federal public Service economy, SMEs, self-employed and energy. » Art. 7. in article 191, paragraph 1, 15 ° f, of the same Act, replaced by the law of 27 December 2005 and amended by the Act of December 28, 2011 § 4 is supplemented by two paragraphs, worded as follows: 'the applicants which, in accordance with paragraph 3, have introduced no later than January 21, 2012 a proposal providing for price reductions for a specialty referred to in article 34 ". ((, 1st paragraph, 5 ° c), 2), for which the intervention of the insurance amounts to 100 per cent of the basis of repayment can introduce no later than March 5, 2012, a proposal with the secretariat of the Commission of providing for the alternative price decreases medication reimbursement calculated on basis of price ex factory for all pharmaceutical specialities which they are liable to January 1, 2012 or some of them ((, with the exception of specialties belonging to classes of antibiotics and antifungal, accompanied by an estimate of the budgetary impact, revealing that the total economic stimulus in annual basis is at least equal to that calculated in annual basis based on the initial proposal for the specialty referred to in article 34, paragraph 1, 5 ° c), 2), for which the intervention of the insurance amounts to 100 per cent of the basis of reimbursement. The proposed decrease may be a maximum of 20 per cent by specialty. If the proposal corresponds to the planned economy, the Minister to remove the initial reduction of the list of specialties of right pharmaceutical remboursabels revised as of April 1, 2012 and adapted from June 1, 2012 the list of reimbursable pharmaceutical specialities based on new proposals introduced.
».

Section 2. -Administrative costs of insurers s. 8A article 195, § 1, 2 °, of the Act, as amended by the royal decree of 25 April 1997, and the laws of 27 December 1994, February 22, 1998, August 22, 2002, December 27, 2005, December 27, 2006, March 26, 2007, 8 June 2008, December 22, 2008, December 23, 2009 and December 29, 2010, the first and second sentences of paragraph (3) are replaced by the following provision : "The expenses of Directors of five national unions is set to 766 483 000 EUR for 2003, 802 661 000 EUR for 2004, 832 359 000 EUR for 2005, 863 156 000 EUR for 2006, 895 524 000 EUR for 2007, 929 160 000 EUR for 2008, 972 546 000 EUR for 2009, 1 012 057 000 EUR for 2010. , 1 034 651 000 EUR for 2011 and 1 029 840 000 EUR for 2012. The Fund of the national Belgian railways company health care, this amount is set to 13 195 000 EUR for 2003, 13 818 000 EUR for 2004, 14 329 000 EUR for 2005, 14 859 000 EUR for 2006, 15 416 000 EUR for 2007, 15 995 000 EUR for 2008, 16 690 000 EUR for 2009 17 368 000 EUR for 2010, 17 770 000 EUR for 2011 and 17 687 000 EUR for 2012. ».
CHAPTER 3. -Amendment of the law of 27 April 2005 relating to the control of the health care budget and amending various provisions regarding health article 9A article 69, paragraph 13, of the Act of 27 April 2005 relating to the control of the health care budget and containing various provisions on health, inserted by the law of December 29, 2010, 'with the exception of specialities included in the reimbursement I.10.1, I.10.2, V.6.3, V.6.4, V.8.1, VII.9, VII.10 and XXII groups' shall be replaced by the words "and for specialties referred to in article 34". ((, first paragraph, 5 °, c), 2), the law on insurance compulsory health care and allowances, co-ordinated on 14 July 1994, containing the same active ingredient, with the exception of specialities included in rebate I.10.1, I.10.2, V.6.3, V.6.4, V.8.1, VII.9, VII.10 and XXII and groups with the exception of specialties for which article 35B, § 2 or § 2A of the Act ", applies.
CHAPTER 4. -Modification of the royal decree No 78 of 10 November 1967 on the exercise of the professions of health care s.
10 § 1. Article 11 of the Decree royal No. 78 of 10 November 1967 on the practice of the professions of health care, amended by law of August 6, 1993 and December 20, 1995, four paragraphs worded as follows shall be inserted after the first subparagraph: "for acute treatment with antibiotics and the antifungal, or when the price of the prescribed medicinal product is greater than the sum of the personal intervention and the intervention of the insurance when they constitute a. amount fixed in accordance with article 37, § 3/2, paragraph 2, of the law on insurance compulsory health care and allowances co-ordinated on 14 July 1994, the pharmacist can substitute for a prescribed medicinal product which is issued in a pharmacy open to the public another medicines with the same active substance or combination of active substances, the same strength , same route of administration and a same frequency of administration, provided that the price is lower and that the prescriber has recorded no therapeutic objection. These reasons for therapeutic objection should be mentioned in the patient's record.
If the prescription includes specifications regarding the form of administration, the substitution referred to in the preceding paragraph is then limited to drugs that meet these specifications.
If the order refers to an allergy to one excipient, which is any component of a drug, other than an active substance and packaging materials, to known effect in accordance with the detailed guidelines issued by the Commission European, the pharmacist may not proceed with a substitution.
The King may, by Decree deliberated in the Council of Ministers, on the advice of the Committee for medicinal products for human use and medical National Commission, declare applicable overriding wholly or in part to other therapeutic classes of medications and possibly there match terms.
The King establishes the rules of procedure. »
§ 2. The § 1 shall enter into force at a date to be determined by the King.
CHAPTER 5. -Amendments to the Act of 6 August 1993 of the social provisions and various arts. 11 A section 34 of the Act of 6 August 1993 by social and diverse, provisions the following amendments are made: 1 ° in the § 1, 1 ° is repealed;
2 ° § 2 is repealed.
CHAPTER 6. -Blocking of the price article 12. from the day of the publication of this Act in the Moniteur belge until December 31, 2012 inclusive, the prices of the drugs referred to in article 313, § 1, of the programme act of 22 December 1989, cannot be increased.
For the applications price increase between the date of publication of this Act in the Moniteur belge and December 31, 2012, the periods specified in article 5, § 2 of the Ministerial Decree of 29 December 1989 concerning the prices of reimbursable drugs, don't start to run from January 1, 2013.
On request of the holder of the marketing authorisation, the Minister that (a) the Economic Affairs in his or her attributions may grant a derogation from the blocking of the price in exceptional cases and provided specific reasons related to the profitability that are proven by the claimant so warrant. The Minister shall communicate its decision within 90 days to the applicant. If the information provided in support of the application are insufficient, it shall notify without delay to the applicant the details of additional information that are required and it takes its final decision within a period of 90 days from the receipt of the additional information. If the number of requests is exceptionally high, the period may be extended only once for 60 days. The applicant is informed of such an extension before the expiration of the unextended time limit.
Promulgate this Act, order that it self under the seal of the State and published by le Moniteur.
Given to Brussels, 17 February 2012.
ALBERT by the King: the Minister of the economy, consumers and the North Sea, J. VANDE LANOTTE the Minister of Social Affairs and public health, examining Beliris and Federal Cultural Institutions, Mrs L.
ONKELINX sealed with the seal of the State: the Minister of Justice, Ms. A. TURTELBOOM _ Note (1) Session 2011-2012.
House of representatives.
Documents. -Bill, 53 2005 - No. 1. -Amendments, 53 2005 - No. 2 to 4. -Reports, 53 2005 - No. 5-7. -Text adopted by the committees, 53 2005 - No. 8. -Amendments submitted after the filing of the report, 53 2005 - No. 9. -Supplementary report, 53 2005 - No. 10. -Text adopted by the committees, 53 2005 - No. 11. -Text adopted in plenary meeting and transmitted to the Senate, 53 2005 - No. 12.
Compte rendu intégral. -2 February 2012.
Senate.
Documents.
-Project mentioned by the Senate, 5-1465 - No. 1. -Amendment 5-1465 - No. 2. -Report 5-1465 - No. 3.
-Decision not to amend, 5-1465 - No. 4.
Annals. -16 February 2012.

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