ISO/IEC 27001:2005Certificate No: IS 567140

The Falsified Medicine Directive

A threat or a blessing?

2

Business profilePharma professional with more than 40 years of experience of which

1. 17 years in local branded pharma business in sales, middle- , senior- and general management positions

2. More than 26 years of generic pharma experience on local, European and global level in general-,and regional management positions

3. 25 years of experience in pharma association work on local and European level, including a 3 years EGA presidency

     

Emile Loof (66 years)

Career chronically1971 Bipharma1975 Rhone Poulenc Pharma1987 Nycomed – general manager1988 - 1996 Pharmachemie B.V. – SVP Marketing & Sales1996 - 2000 Managing Director Pharmachemie B.V.2000 – 2014 President and CEO Pharmachemie B.V.2006 – 2014 member European Leadership Team Teva1988 – present Secretary Dutch Generic Association2004 - 2014 Executive of the European Generic Association (EGA)2005 – 2007 President EGA2014 – present Pharma consultant

EGA Membership

HeGA(Greece)

SPMA (Slovenia

)

CO

MP

AN

IES

NA

TIO

NA

L

AS

SO

CIA

TIO

NS

GE (Hungary

)

3

Falsified Medicines Directive (2011/62/EU) Accepted by EU parliament in 2011

The prevention of the entry of falsified medicines into the legal supply chain for prescribed pharmaceuticals

Applicable for prescription medicines only

NOT applicable for OTC products ??? NOT covering products offered on internet !!! ALL product-packs have to carry an unique identification

ALL product-packs have to be tampering-proof

Authentication of ALL products at dispensing-point4

Delegated Act A DA allows Parliament and the Council to delegate to the Commission

the power to adopt "non-legislative acts of general application to supplement or amend certain non-essential elements of a legislative act"

Enacting terms:

Technical characteristics of the Unique Identifier

Verification of the Safety Features

Repository for the Unique Identifier

Procedure for notification of exceptions by Member States

5

Impact Assessment – Outcome (I) Establishment and management by stakeholders with supervision by the relevant

competent authorities

Harmonisation of the composition of the number and the data carrier to fight against falsified, recalled and expired medicines

The UI shall contain the following information:

Manufacturer product code

Serial number SECURITY!!! Expiry date

Batch number

National reimbursement number, if present

The UI will be carried by a 2D matrix code.

6

Impact Assessment – Outcome (II) Systematic verification of the safety features at the point of dispense

and risk-based verification by wholesale distributors

Medicines will be systematically checked-out at the point of dispense

Wholesale distributors will verify the safety features when:

The product is not obtained from the holder of the manufacturing authorisation or the holder of the marketing authorisation;

The product is returned by another wholesale distributor or a pharmacy.

7

Impact Assessment – Outcome (in practice)The manufacturers and parallel importers will have to ensure that:

The unique identifier is placed on the pack for authentication;

The serial number can be checked out at the dispensing point;

The repository system is suitable to ensure authentication of medicinal products at the dispensing point;

The response from the repository system is virtually instantaneous;

The repository system guarantees the protection of commercial, confidential and personal data;

The concerned competent authorities have full access to the repository system and can supervise its functioning.

8

Delegated Act timelines

Mid-2015: Adoption by European Commission

End-2015: Publication in Official Journal

Transitional measures 3 year transition phase (till end-2018) fade-out phase till expiry date of products 6 additional years for countries with a system for verifying

authenticity (BE, IT, HE)

9

Stakeholders take action to protect patients from falsified medicines

VISION

• Protect legal medicines supply chain throughout EU

• Comply with FMD in an effective and cost-efficient way

STATUS

• Design for Pan-European system and governance in place:National systems connected by European Hub

• Start up implementation in place

PLAN• Work with EU and national authorities as well as

EU and national stakeholder associations towards effective rollout

10

Common basic concept: unique identifierData-Matrix code, developed to ISO-standardsKey data elements:

→ Product code (GTIN/NTIN or PPN)→ Randomised unique serial number→ Expiry date → Batch number→ National health number (where necessary)

Product #: 09876543210982Batch: A1C2E3G4I5Expiry: 140531S/N: 12345AZRQF1234567890

Expected to be required by Delegated Acts

11

Common basic concept: “Point of dispense verification”

Expected to be required by

Delegated Acts

12

Pan-European architecture: design for interoperability and efficiency

NationalSystem NationalSystem

PharmaceuticalManufacturer

ParallelDistributor

NationalSystem NationalSystem

NationalSystem NationalSystem

NationalSystem NationalSystem

NationalSystem NationalSystem

EuropeanHub

EuropeanHub

NationalSystem NationalSystem

WholesalerPharmacy

Conclusions:

A proper implemented FMD will definitely create a high barrier of entry for falsified medicines to enter the legal supply chain.

Regarding the technical implementation of the serialisation activities by industry : DO NOT forget the security element! (how safe is your environment)

To be ready for 01-01-2019 industry and all stakeholders have to start acting now!

15

Q&A