Principles

Objectives

1. The purpose of the association is to represent the common interests of officially recognised manufacturers of autogenous vaccines and antisera for animals.

2. The function of the association is

a) to represent members’ interests to parliaments, ministries, authorities, stakeholders like parliaments, ministries, authorities and academia, on all matters important to our members in the area of autogenous vaccines and antisera for animals.

b) to coordinate members’ policy-forming processes and to enforce common interests;

c) to provide advisory support in regulatory and legislative matters, and the specification of laws and legislative motions relevant to members nationally and internationally in Europe

d) to inform the public of the function and activities of the association and its members, in particular to demonstrate the positive impact of autogenous vaccines and sera regarding animal welfare and animal health

e) to ensure high level product quality standards based on requirements determined by laws, regulations and technical standards and standards set out by the association;

f) to carry out press and PR work in connection with the association’s duties and

g) to collaborate with associations and organisations in the field of animal vaccines and antisera, e.g. veterinary organisations and universities.

3. The association will not operate as a commercial business.

Mission

The start of EMAV was driven by the legislative process to create a legal framework and hereby to harmonization the rules for production and use of autogenous vaccines and sera within the EU.

EU-Regulation 2019/6 on Veterinary Pharmaceuticals includes these products for the future and requests the development of a future new GMP standard especially for these products.

EMAV aims for a partnership with veterinarians in practice as well as with any other stakeholders wants to strengthen the health of both animals and humans by the prophylactic use of autogenous vaccines and sera in animals.

With decades of experience in production and use of autogenous vaccines and sera, the EMAV members want to help developing the future GMP standards in a way to combine securing the safety and ensuring the availability of the products, even for very small number of customers.

Harmonization

Members of EMAV are currently working under different national frameworks being in place for their site location.

EU-regulation 2019/6 will harmonise the legal framework for autogenous vaccines and sera from January 28th, 2022.

The members of EMAV would like to contribute their many years of experience to this process of harmonisation, especially by developing the future GMP-standard, specific to these products.

All members of EMAV support that the quality standard as proposed by the European Medicines Agency in 2017 (EMA/CMDv/452656/2016) is a good benchmark of the GMP standards that must be developed for autogenous vaccines.

Antitrust guidelines for EMAV

While some activities among competitors are both legal and beneficial to the industry, group activities of competitors are inherently suspect under the antitrust laws. Agreements or combinations between or among competitors need not be formal to raise questions under antitrust laws, but may include any kind of understanding, formal or informal, secretive or public, under which each of the participants can reasonably expect that another will follow a particular course of action.

Each member and all EMAV e.V. association representatives are responsible to see that topics, which may give an appearance of an agreement that would violate the antitrust laws, are not discussed at meetings or on calls. It is the responsibility of each participant in the first instance to avoid raising improper subjects for discussion. This reminder has been prepared to assure that participants in meetings and on calls are aware of this obligation. The Dos and Don’ts below highlight only the most basic antitrust principles. Each participant in a meeting should be thoroughly familiar with his/her responsibilities under the antitrust laws and should consult counsel in all cases involving specific situations, interpretations or advice.

Don't

1. Do not, in fact or appearance, discuss or exchange information regarding:

a) Individual company prices, price changes, price differentials, mark-ups, discounts, allowances, credit terms, etc., or data that bear on price, e.g. costs, production, capacity, inventories, sales, etc.

b) Industry pricing policies, price levels, price changes, differentials, etc.

c) Changes in industry production, capacity or inventories.

d) Bids on contracts for particular products; procedures for responding to bid invitations.

e) Plans of individual companies concerning the design, production, distribution or marketing of particular products, including proposed territories or customers.

f) Matters relating to actual or potential individual customers or suppliers that might have the effect of excluding them from any market or of influencing the business conduct of firms toward such suppliers or customers.

2. Do not discuss or exchange information regarding the above matters during social gatherings incidental to meetings, even in jest.

Do

1. Have an agenda and adhere to prepared agendas for meetings and calls.

2. Get minutes taken and object if they do not accurately reflect the discussion and actions taken.

3. Consult with your legal counsel on all antitrust questions relating to meetings.

4. Protest any discussions or meeting activities which appear to violate the antitrust laws; disassociate yourself from any such discussions or activities and leave any meeting in which they continue.