Regulatory procedures for drugs in Belgium - · PDF fileRegulatory procedures for drugs in...

Regulatory procedures for drugs in Belgium

Société Belge de PédiatrieBelgische Vereniging voor Kindergeneeskunde

19/03/2005Anne Matrie HUBERT

Overview of procedures in BelgiumOverview of procedures in Belgium

1. Registration

2. Price

3. Reimbursement

Sales possible (without reimbursement) Full launch

M. Public Health

(or EU Commission)

M. Economy

M. Social affairs

Regulatory procedures in BelgiumRegulatory procedures in Belgium

1. Drug registration? Ministry of public health

2. Pricing? Ministry of economic affairs

3. Reimbursement by the sick funds? Ministry of social affairs (INAMI/RIZIV)




Product registrationProduct registration

• Development of a new drug

• Content of a registration dossier

• Procedures

• Development of a new drug

• Content of a registration dossier

• Procedures

Product developmentProduct development

?Synthesis/production of new molecules or proteins?Screening? Tests in animals: toxicology & pharmacology?Development of a pharmaceutical formulation

(pilot scale & full production scale)

? Tests in humans:? phase I studies: pharmacodynamic and pharmacokinetic studies (volunteers)? phase II and phase III studies to define safety and efficacy profile in patients populations

?Synthesis/production of new molecules or proteins?Screening? Tests in animals: toxicology & pharmacology?Development of a pharmaceutical formulation

(pilot scale & full production scale)

? Tests in humans:? phase I studies: pharmacodynamic and pharmacokinetic studies (volunteers)? phase II and phase III studies to define safety and efficacy profile in patients populations

Mean duration of developmentMean duration of development

3.25.1 5.9 6.1

2.5

4.42.4

2.1

2.8 1.8

6.35.5

14.2 Years14.2 Years

11.6 Years

8.1 Years

1960's 1970's 1980's 1990's

Approval Phase

Clinical Phase

Preclinical Phase

Source: DiMasi et al., “New Drug Development in U.S. 1963-1999.” Clinical Pharmacology &Therapeutics 2001. May, 69(s).

±12 years of development ; cost ? 800 mio USD

Content of a new product registration dossier

Content of a new product registration dossier

Should ensure quality, safety, efficacy

? Chemical and pharmaceutical data?defines the product quality

? Pharmacological and toxicological data (non-clinical data):?defines the product pharmacological properties?defines the product safety & toxicology in animals

? Clinical data (data in humans)?defines the product actions in humans:

pharmacokinetics, efficacy and safety.

Should ensure quality, safety, efficacy

? Chemical and pharmaceutical data?defines the product quality

? Pharmacological and toxicological data (non-clinical data):?defines the product pharmacological properties?defines the product safety & toxicology in animals

? Clinical data (data in humans)?defines the product actions in humans:

pharmacokinetics, efficacy and safety.

Content of a product registration dossier

Content of a product registration dossier

Admin. info

Quality

overall summary

Non clinical

overall summary

Clinical

overall summary

Quality body of data

Module 1

Module 2

Module 3 Module 4 Module 5

Non clinical study reports

Clinical study reports

Procedures for drug registrationProcedures for drug registration

3 possibilities:

1. National procedure 2. European procedure by mutual recognition3. European centralised procedure

3 possibilities:

1. National procedure 2. European procedure by mutual recognition3. European centralised procedure

National procedureNational procedure

Product registration delivered by the Belgian authorities, on the basis of an evaluation by national authorities

? the only existing procedure for products registered before 1976

? still the procedure used for most products registered before 1998

? very strong limitations since 1998: can only be used for local products (products not intended to be marketed in more than one member state)

? exception: new extension for an already existing product approved by national procedure (e.g. new pharmaceutical form).

Product registration delivered by the Belgian authorities, on the basis of an evaluation by national authorities

? the only existing procedure for products registered before 1976

? still the procedure used for most products registered before 1998

? very strong limitations since 1998: can only be used for local products (products not intended to be marketed in more than one member state)

? exception: new extension for an already existing product approved by national procedure (e.g. new pharmaceutical form).

European procedure by mutual recognition

European procedure by mutual recognition

The assessment of the first member state is ‘recognised’ by the other EU member states.

? The first member state to approve a new product acts as the ‘reference member state’.

? The reference member state justifies its basis for approval by issuing an assessment report which is sent to all other concerned member states

?Other member states have 60 days to object the decision of approval (only on the basis of serious public health issues)

The assessment of the first member state is ‘recognised’ by the other EU member states.

? The first member state to approve a new product acts as the ‘reference member state’.

? The reference member state justifies its basis for approval by issuing an assessment report which is sent to all other concerned member states

?Other member states have 60 days to object the decision of approval (only on the basis of serious public health issues)

European centralised procedureEuropean centralised procedure

Central evaluation made for Europe and coordinated by the European Medicines Agency (EMA) based in London

?An application is submitted to the EMEA? The EMEA appoints a rapporteur and a co-rapporteur who

should coordinate the assessment of the dossier.? The scientific European Committee for Human Medicinal

Products gives an advice? To be confirmed by the European commission? The product licence is delivered by the European

Commission: one licence for the whole of Europe.

Central evaluation made for Europe and coordinated by the European Medicines Agency (EMA) based in London

?An application is submitted to the EMEA? The EMEA appoints a rapporteur and a co-rapporteur who

should coordinate the assessment of the dossier.? The scientific European Committee for Human Medicinal

Products gives an advice? To be confirmed by the European commission? The product licence is delivered by the European

Commission: one licence for the whole of Europe.

Price dossierPrice dossier

• Details on the product (dose, pack size, indications, etc.)

• Prices of equivalent products in Belgium• Prices of same product in other European countries• Country of origin• Details on price requested with:

– Purchase price– Costs for import, quality assurance, transport– Distribution costs: medical information, salaries,

others– Profit margin– Wholesaler, pharmacist and public prices

• Details on the product (dose, pack size, indications, etc.)

• Prices of equivalent products in Belgium• Prices of same product in other European countries• Country of origin• Details on price requested with:

– Purchase price– Costs for import, quality assurance, transport– Distribution costs: medical information, salaries,

others– Profit margin– Wholesaler, pharmacist and public prices

Procedure for reimbursable products

Procedure for reimbursable products

New product or price increaseNew product or price increase

Price application

Pricing committeeC.P.S.P./P.F.S.

Concertation committee

Decision minister

Notification

90 days

Reimbursement procedureReimbursement procedure

sec

0 10 20 30

expertssec

M. Economic Aff.

40 60 8050 70 90 100 120 140 160 180110 130 150 170 190 200

CRM/CTG

CRM/CTG

M.SocialAff.

fin

bud

StateCouncil

Publication

Applicant Applicant

6 months for the decision, 2-3 months for publication

• Milestones: day 60 report, provisional motivated decision (d 120), definitive decision (d 150) and minister’s decision (d 180)• 2 opportunities to comment: after day 60 report and after day 120

CRM/CTG

experts

Composition of reimbursement committee (CRM/CTG)

Composition of reimbursement committee (CRM/CTG)

Experts (universities)

Sick funds

Physicians

Pharmacists

External expertsInternal experts (5) +

Bureau CRM/CTG (1+2)

CRMdecides (2/3)

77

88

4433

+ 2 industry rep.consult. voice

Admission criteriaAdmission criteria

?Reimbursement allowed only for products under prescription

? Products must present a social interest and meet certain criteria:– Therapeutic value (see next slide)– Price and basis of reimbursement requested– Interest in the medical practice in function of

therapeutic and social needs (N/A generics)– Budget impact– Ratio between cost for the sick funds and

therapeutical value ? P/E dossier! (N/A generics)

?Reimbursement allowed only for products under prescription

? Products must present a social interest and meet certain criteria:– Therapeutic value (see next slide)– Price and basis of reimbursement requested– Interest in the medical practice in function of

therapeutic and social needs (N/A generics)– Budget impact– Ratio between cost for the sick funds and

therapeutical value ? P/E dossier! (N/A generics)

Admission criteriaAdmission criteria

? Therapeutic value:– Added value when therapeutic value is

higher than that of a standard treatment.– 3 classes of products:

• Class 1: added value demonstrated compared to existing alternatives ?higher price possible

• Class 2: no demonstrated added value but no generic of copy product ? no higher price

• Class 3: generics and copy products ?lower price

? Therapeutic value:– Added value when therapeutic value is

higher than that of a standard treatment.– 3 classes of products:

• Class 1: added value demonstrated compared to existing alternatives ?higher price possible

• Class 2: no demonstrated added value but no generic of copy product ? no higher price

• Class 3: generics and copy products ?lower price

Content of a reimbursement dossier

Content of a reimbursement dossier

?Details on the product (dose, pack size, indications, etc.)

?Copies of product registration documents?Copy of price application?Reimbursement proposal (with price, conditions,

category, etc)? Justification of the proposal with scientific

motivations, clinical, epidemiological, pharmaco-economic studies, published (or not-published)

?Details on the product (dose, pack size, indications, etc.)

?Copies of product registration documents?Copy of price application?Reimbursement proposal (with price, conditions,

category, etc)? Justification of the proposal with scientific

motivations, clinical, epidemiological, pharmaco-economic studies, published (or not-published)

ConclusionConclusion

• Product development is an expensive, risky and lengthy process

• Registration application review and approval process lasts in average about 16-18 months

• Price & reimbursement applications takes about 8-9 months to complete (when successful!)

• Product development is an expensive, risky and lengthy process

• Registration application review and approval process lasts in average about 16-18 months

• Price & reimbursement applications takes about 8-9 months to complete (when successful!)

Regulatory procedures for drugs in Belgium - · PDF fileRegulatory procedures for drugs in...

Documents

Transcript of Regulatory procedures for drugs in Belgium - · PDF fileRegulatory procedures for drugs in...