belgiquelex.be - Carrefour Bank of Legislation

17 FEBRUARY 2012. - Act respecting various health-related urgent provisions (1)

ALBERT II, King of the Belgians,
To all, present and to come, Hi.
The Chambers adopted and We sanction the following:
CHAPTER 1^er. - Introductory 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. - Medication measures
Art. 2. 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 23 December 2009, the following amendments are made:
1° § 2bis, paragraph 3, is supplemented by a 4°, written as follows:
"4° where the speciality reimbursement base consists of a fixed amount by indication, treatment or examination, for the drug or all of the medications that are dispensed for this indication, treatment or examination. »;
2° in § 2bis, paragraph 4, the words "and 3°" are replaced by the words ", 3° and 4°";
3° § 12 is supplemented by the words" and, by royal decree deliberated in the Council of Ministers, in the cost of pharmaceutical specialties for which substitution is authorized in accordance with Article 11 of Royal Decree No. 78 of 10 November 1967 concerning the exercise of the professions of health care".
Art. 3. In section 35ter of the Act, replaced by the Act of 27 December 2005 and amended by the Acts of 25 April 2007, 22 December 2008, 10 December 2009, 23 December 2009 and 29 December 2010, the following amendments are made:
1° to § 1^er, paragraph 4, the words "31 p.c." are replaced by the words "41 p.c. for specialties for which the intervention of the insurance represents 100 p.c. of the refund base and 31 p.c. for other specialties";
2° to § 1^er, paragraph 6, the words "5.5 p.c. complementary" are replaced by the words "7 p.c. complementary for the specialties for which the intervention of the insurance represents 100 p.c. of the refund base and 5.5 p.c. complementary for the other specialties";
3° to § 2, paragraph 1^erthe words “The reduction referred to in § 1^erParagraph 1^er is not applied to the injectable form of specialities or to " are replaced by the words "The reductions referred to in § 1^er are reduced to half of the percentages referred to in § 1^er for the injectable form of specialties or for ";
4° to § 2bis, the words "The reduction referred to in § 1^er, paragraph 2, is not applied" are replaced by the words "The reductions referred to in § 1^er are reduced to half of the percentages referred to in § 1^er »;
5° a § 7 is inserted as follows:
“§ 7. 1^er April 2012, reductions referred to in § 1^er are applied, taking into account the provisions of §§ 2 and 2bis, to the specialties which fall within the scope of this §, and for which these reductions have not yet been applied. »
6° it is inserted a § 8, written as follows:
Ҥ 8. 1^er April 2012:
(a) the basis for reimbursement of specialties for which the intervention of insurance is 100 per cent of the reimbursement base and for which a new reimbursement base has been fixed after 1^er April 2008 on the basis of the provisions of § 1^er, if applicable by the application of section 35quater, as well as for the specialties referred to in article 34, paragraph 1^er, 5°, c), 2), containing the same active principle, is diminished in full law by 14,49 p.c. additional;
(b) the basis for the reimbursement of specialties for which the intervention of insurance is 100 per cent of the reimbursement base and for which a new reimbursement base has been fixed before 1^er April 2008 on the basis of the provisions of § 1^er, if applicable by the application of section 35quater, as well as for the specialties referred to in article 34, paragraph 1^er, 5°, c), 2), containing the same active principle, is diminished in full right by 15.84 p.c. complementary. »;
7° § 1^er is supplemented by a paragraph, which reads as follows:
"The reduction referred to in paragraphs 5 and 6 is also applied to specialties containing the same active principle, but to which the provisions of paragraph 1^er or 2 are not applied. "
Art. 4. In section 37 of the Act, last amended by the Act of 19 May 2010, the following amendments are made:
1° in § 3/2, paragraph 2, the words: "This personal intervention may consist of a fixed amount by indication, treatment or examination" are replaced by the words "This personal intervention and/or refund may consist of a fixed amount by indication, treatment or examination for the drug or";
2° § 3/2, paragraph 3, is supplemented by the words "In the same way, the King determines by a deliberate decree in the Council of Ministers the classes of medicines which may be the subject of an intervention in the form of a fixed amount by indication, treatment or examination. »;
3° it is inserted a § 3/3, written as follows:
§ 3/3. For drugs referred to in section 34, paragraph 1^er, 5°, a), b) and c), which are dispensed to beneficiaries who stay in rest and care homes and day-care centres, approved by the competent authorities, or in rest homes for the elderly or short-term care centres, approved by the competent authority, or in institutions that, without being registered as rest homes, constitute the domicile or common residence of the elderly, and who meet the conditions of the King's health care
For the cost of the above-mentioned drugs, no amount other than the personal intervention established by the King can be taken into account to the beneficiaries. »
Art. 5. In section 72 of the Act, replaced by the Act of 25 January 1999 and amended by the Acts of 24 December 1999 and 10 August 2001, the following amendments are made:
1° in paragraph 1^er, the words "to be kept within previously fixed limits" are replaced by the words "to be mastered";
2° in paragraph 2, the words "or not" are inserted after the words "determined periods";
3° in paragraph 3, the words "planned volumes and price adjustments" are replaced by the words "planned volumes and/or planned price adjustments";
4° in paragraph 4, the words "two procedures" are replaced by the words "the following procedures";
5° Paragraph 4 is supplemented by a 3°, which reads as follows:
"3° is based on an application by the company as part of a lower price imposed under the 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".
Art. 6. Article 72bis, § 1^erthe same law, inserted by the Act of 20 December 1995, replaced by the Act of 10 August 2001 and amended by the Acts of 27 December 2006, 22 December 2008 and 19 May 2010, is supplemented by the 8°, as follows:
« 8° communicate no later than 1^er April 2012 and then every time after 1^er February and before 1^er March of each year, at the Institute Health Care Service, the ex-factory prices in effect on 1^er January of the year concerned in the Member States of the European Union designated by the King, on the proposal of the Minister of Economy and the Minister of Social Affairs, for the pharmaceutical specialties referred to in article 34, paragraph 1^er, 5°, b). These data are transmitted immediately by the Institute to the Federal Public Service Awards Service Economics, SMEs, Average Classes and Energy. »
Art. 7. In section 191, paragraph 1^er, 15° septies, of the same law, replaced by the law of 27 December 2005 and last amended by the law of 28 December 2011, § 4 is supplemented by two paragraphs, as follows:
"Applicants who, pursuant to paragraph 3, have introduced, by January 21, 2012, a proposal for price reductions for a specialty referred to in section 34, paragraph 1^er, 5°, c), 2), for which the intervention of the insurance is 100 per cent of the reimbursement base may introduce, by March 5, 2012, a proposal to the secretariat of the Refunding Commission of Medicines providing for reductions of alternative prices, calculated on the basis of the ex factory price, for all pharmaceutical specialties of which they are responsible at 1^er January 2012 or some of them, with the exception of specialties belonging to the classes of antibiotics and antibiotics, together with an estimate of the budget incidence suggesting that the total amount of the economy expected on an annual basis is at least equal to that calculated on an annual basis on the basis of the original proposal for the specialty referred to in section 34, paragraph 1^er, 5°, c), 2), for which the insurance intervention is 100 percent of the refund base. The proposed decrease may be up to 20 p.c. per specialty. If the proposal corresponds to the expected economy, the Minister shall delete, in full law, the intial decrease in the list of modified drug specialties from 1^er April 2012 and adapted from 1^er June 2012 the list of reimbursable pharmaceutical specialties based on the new proposals introduced. "
Section 2. - Fees for the administration of insurance organizations
Art. 8. Article 195, § 1^er, 2°, of the same Act, as amended by the Royal Decree of 25 April 1997, and by the Acts of 27 December 1994, 22 February 1998, 22 August 2002, 27 December 2005, 27 December 2006, 26 March 2007, 8 June 2008, 22 December 2008, 23 December 2009 and 29 December 2010, the first and second sentences of paragraph 3 are replaced by the following provision:
"The administration fee for the five national unions is set at EUR 766,483,000 for 2003, EUR 802,661,000 for 2004, EUR 832,399,000 for 2005, EUR 863,156,000 for 2006, EUR 895,524,000 for 2007, EUR 929,160,000 for 2008, EUR 972,000 for 2009, EUR 012,057,000 for 2010, EUR 1,034,651,000 for 2011 and EUR 1,029,840,000 for 2012. This amount is set at EUR 13,195,000 for 2003, EUR 13,818,000 for 2004, EUR 14,329,000 for 2005, EUR 14,859,000 for 2006, EUR 15,416,000 for 2007, EUR 15,995,000 for 2008, EUR 16,690,000 for 2009, EUR 17,368,000 for 2010, EUR 17,770,000 for 2011 and EUR 17,687,000 for 2012. "
CHAPTER 3. - Amendment of the Act of 27 April 2005 on the Control of the Health Care Budget and on various health provisions
Art. 9. Article 69, paragraph 13, of the Act of 27 April 2005 relating to the control of the health care budget and bearing various health provisions, inserted by the law of 29 December 2010, the words "with the exception of the specialties repeated in the reimbursement groups I.10.1, I.10.2, V.6.3, V.6.4, V.8.1, VII.9, VII.10 and XXII" are replaced by the words "and for the specialties referred to in
CHAPTER 4. - Amendment of Royal Decree No. 78 of 10 November 1967 on the Exercise of Health Care Professions
Art. 10. § 1^er. In article 11 of Royal Decree No. 78 of 10 November 1967 on the Exercise of Health Care Professions, as amended by the Acts of 6 August 1993 and 20 December 1995, four paragraphs are inserted after the first paragraph:
"For acute treatments with antibiotics and antimycotics, or where the price of the prescribed drug specialty is greater than the sum of the personal intervention and the intervention of the insurance when they constitute a fixed amount under section 37, § 3/2, paragraph 2, of the law relating to compulsory health care and coordinated allowances of July 14, 1994, the pharmacist may substitute for an active substance These reasons for the therapeutic objection must be mentioned in the patient's file.
If the prescription contains specifications for the form of administration, the substitution referred to in the preceding paragraph is then limited to the drugs that meet these specifications.
If the order mentions an allergy to an excipient, that is, any component of a drug, other than an active substance and packaging materials, which is notorious in accordance with the detailed guidelines published by the European Commission, the pharmacist may not make a substitution.
The King may, by deliberate order in the Council of Ministers, on the advice of the Commission on Human Drugs and the National Medico-mutualist Commission, declare the substitution applicable entirely or partially to other therapeutic classes of medicines and possibly to include terms. The King establishes the rules of procedure. »
§ 2. § 1^er comes into force on a date to be determined by the King.
CHAPTER 5. - Amendments to the Act of 6 August 1993 on social and other provisions
Art. 11. In section 34 of the Act of 6 August 1993 on social and other provisions, the following amendments are made:
1° in § 1^er1° is repealed;
2° § 2 is repealed.
CHAPTER 6. - Price blocking
Art. 12. From the day of the publication of this Act to the Belgian Monitor until 31 December 2012 inclusive, the prices of the drugs referred to in Article 313, § 1^er, of the programme law of 22 December 1989, cannot be increased.
For requests for price increases introduced between the day of the publication of this Act to the Belgian Monitor and 31 December 2012, the deadlines provided for in Article 5, § 2, of the Ministerial Order of 29 December 1989 on the prices of refundable drugs, begin to run only from 1^er January 2013.
At the request of the holder of the marketing authorization, the Minister who has the Economic Affairs in his or her powers may grant an exemption to price blocking in exceptional cases and provided that specific reasons for profitability that are proven by the applicant justify it. The Minister shall notify the applicant within 90 days. If the information provided in support of the application is insufficient, the applicant shall promptly notify the applicant of the additional information required and shall make its final decision within 90 days of receipt of the additional information. If the number of requests is exceptionally high, the deadline can be extended once only 60 days. The applicant is informed of such an extension before the expiry of the initial period.
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 17 February 2012.
ALBERT
By the King:
Minister of Economy, Consumers and the North Sea,
J. VANDE LANOTTE
The Minister of Social Affairs and Public Health, in charge of Beliris and Federal Cultural Institutions,
Ms. L. ONKELINX
Seal of the state seal:
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. 2-4. - Reports, 53 2005 - No. 5-7. - Text adopted by the commissions, 53 2005 - No. 8. - Amendments submitted after the report was filed, 53 2005 - No. 9. - Supplementary report, 53 2005 - No. 10. - Text adopted by the commissions, 53 2005 - No. 11. - Text adopted in plenary and transmitted to the Senate, 53 2005 - No. 12.
Full report. - 2 February 2012.
Senate.
Documents. - Project referred to 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.
Annales. - 16 February 2012.