Marlene Delgado and Protao

Anticipating big changes

The new veterinary medicine legislation becomes applicable at the end of this month. We talked to a veterinarian Marlene Delgado, who is also one of the technical directors of Zoopan. She shared her insights about the impact the new regulation has on companies and animal health. As the qualified person for pharmacovigilance and as responsible for regulatory affairs, she has been active in Access VetMed’s working groups giving industry input to the European Commission and EMA.

Q: The new veterinary medicines legislation will be applicable from 28 January 2022. There is a years’ work behind it. Tell us a bit more about that?

A: It has been challenging and rewarding. Working alongside with all Access VetMed (and former EGGVP) colleagues has been an invaluable learning experience. I have tried to be involved as much as possible, especially when it comes to matters related to pharmacovigilance. I also volunteer in the labelling working group. This extra work is carried out alongside my daily responsibilities, but I have received green light from our administration to take on these extra duties.

As one of the Access VetMed’s smallest companies, Zoopan can provide a different perspective. In return, we get access to a knowledge sharing network of companies operating in different countries where we do not yet have a presence. It benefits us all.

Access VetMed’s members are truly open and cooperative with each other which is quite impressive. There is no competition. We work together towards a common goal.

Q: What would you consider Access VetMed’s most important achievement in the EU context?

A: Most recently, I would highlight the joint effort to get the European Parliament reject a motion aimed at restricting the scope of antibiotic use for animals. It was extremely rewarding to see our outreach pay off: the national stakeholders and MEPs listened to our message and understood the consequences for animal health.

Q: What has been the most challenging issue?

A: There is still a lot of uncertainty with regards the new legislation. It may create significant regulatory hurdles for companies such as ours.

Work on the new pharmacovigilance guidelines was very laborious. It was however gratifying to see our comments taken into account by EMA. The outcome is not perfect, but we have been heard, and that is important.

Q: What would you say is the biggest change the legislation brings to the generic producers and to animal health?

A: Certainly, we will see big changes in pharmacovigilance. The legislation enhances reporting on adverse effects, which in turn increases the safety of medicines. The same applies to the antimicrobials. Their responsible use is extremely important for the health of all, animals, humans, and the environment.

The new legislation is also supposed to increase medicine availability. Product registration for minor use and minor species, and procedures for small companies should become more flexible. The extended data protection period can, however, create barriers to availability.

Q: How did Zoopan first become active in the EU market?

A: We were well known in Portugal, but in 2013, we started investing in generics with the intent to grow in the European market.

The Portuguese authority was very helpful in the early stages. The marketing authorisation process required a lot of work in a short timeframe, so we started slowly with just six countries. From there, step-by-step, we have expanded to other countries.

Q: What would you consider the most important qualities of the generics for veterinarians and animal owners?

A: We always listen to veterinarians and animal owners, which leads to constant product improvements. These can range from improved solubility and species-adapted dosages to easy-to-use packaging.

In Zoopan, we also have flexibility. When the covid-19 pandemic started, there were hardly any hand sanitisers in the market. We responded quickly to the situation and reorganised and updated our manufacturing facilities and clean rooms to include ATEX rooms so that we could produce alcohol-based sanitisers for human use.

Q: What about generics’ impact for animal health?

They bring a significant added value, especially when it comes to MUMs. They respond to clinical needs of the smaller, minor species. Without them, veterinarians may face challenges in treating small species such as canaries or racing pigeons. They are good examples of animals that require very small dosages and for whom the easiest way to administer the medicine is to dilute it in water.

Q: What is your favourite animal and why?

A: This is not an easy one. I admire wild animals, tigers and lions…but I would say dogs are my favourites for their ability to express unconditional love and companionship. I have a Malinois Belgian Shepherd, Protão. Before him, I had two German Shepherds. Dogs are part of my family and they have brought us unforgettable, shared memories.

Zoopan

Zoopan was founded in 1980 as a Portuguese family-owned company. Starting with nutritional products for animals, it soon expanded to veterinary medicines. In 2015, Zoopan was acquired by Lusiaves Group, one of the country’s major poultry sector operators. Today, Zoopan covers the whole product cycle from manufacturing to distribution, and offers treatments for a variety of species, including products for the minor use and minor species (MUMs).

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