Availability of veterinary medicines in Ireland
Even if it is the case that Ireland has an international reputation both for the quality of our food products around the world as well as the quality of our horses abroad, the market size for veterinary medicines is relatively small, being about 1/6 of our near neighbour, the UK, and considerably smaller than that of France, Germany and the Netherlands.
The relative size of the Irish market and profit potential are key determinants in the decision on whether or not to market a veterinary medicine in this country, even if there should be a suitable product already authorised in another EU country (figure 1). The national legislation cannot force a company to market a veterinary medicine in Ireland, even if there is a need for the product in this country.
Problems of non-availability can arise from a number of issues and different solutions are needed depending on the issues involved.
To begin, the animal health market is substantially different to that of human medicines:
- Globally, the veterinary market is only 2-3% of the size of that for human medicines. Unlike the case for human medicines where public health agencies often contribute towards the price of the medicine, the market driver for veterinary medicines is entirely commercial. This means that companies will only invest in the cost of developing a new medicine where there is a commercial return.
- Unlike human medicines, there are a wide variety of different animal species (fish, bees, poultry, companion animals, livestock, horses, exotic and zoo species etc.) which all require medicines. These species have their own physiology and diseases, meaning that the drugs must be developed and customised for the peculiarities of the individual species in order to ensure they work effectively and the animals can be medicated appropriately.
- Animals and animal diseases are often clustered in certain areas, meaning that the demand for veterinary medicines is not evenly spread (e.g. fish medicines are only of interest to those countries with coasts and rivers). Moreover, while some parasites, bacteria and viruses cross between two or more species, others are species specific and require uniquely developed medicines.
- Animals and their produce form the food sources for many humans. This means that in addition to meeting the standard quality, safety and efficacy criteria for medicines themselves (as for medicines developed for humans) they must additionally be evaluated for the impact of their drug residues for consumer safety. Such studies are expensive to conduct.
- The market is highly fragmented, as within each species different product formulations have to be developed to medicate the different animal sizes and requirements e.g. intramammary medicines for use in the cow’s udder, premixes for feeding to pigs, oral soluble powders for use in drinking water of poultry, as well as traditional formulations of tablets, injectables, and topical products.
Given the difficulties in availability of authorised veterinary medicines for each disease in each species, the EU legislation provides for the exceptional use of veterinary medicines developed for another target species, or for human use, or that is prepared extemporaneously in a procedure that is known as ‘cascade use’. In Ireland, the procedure for exceptional importation and use of veterinary
medicines is regulated by the Department of Agriculture, Food and the Marine (DAFM). DAFM has established a protocol to provide stakeholders with a means of communicating potential shortages, with a view to investigating solutions and potential risk mitigation measures. A link to the DAFM protocol and relevant forms is attached here. Furthermore, DAFM has established a specific email address for queries on shortages (firstname.lastname@example.org).
At the international level, efforts are continuing to improve the availability of veterinary medicines by means of a number of initiatives. Furthermore, the HPRA has also developed a number of initiatives to assist companies in applying for a marketing authorisation for veterinary medicine that is being marketed in another EU member state. Brexit represents a significant additional challenge to the availability of veterinary medicines in Ireland, as more than 50% of the products on the Irish market share a common label with the UK and it is not certain whether this can be maintained in common for the future.
An additional issue that can arise is product shortages. These may arise for many different reasons, including:
- Manufacturing issues: Increasingly, the manufacture of active substances and medicines themselves are consolidated in one or a few global sites. This leaves the production process vulnerable to issues that can arise. Locally, medicines cannot be released onto the market unless that they are judged to have met their manufacturing release specification. It follows that if the manufacture of the product results in out of specification batches being produced, they cannot be marketed.
- Changes or developments in regulatory science: These can arise as a result of new scientific data which calls into question an aspect of the original authorisation decision and the benefit/risk judgement (e.g. new adverse reactions or new environmental impact data on a medicine).
- Poor market forecasts or unpredictable demand: Diseases can arise without prior warning leading to unexpected demand for a medicine. Moreover, within the EU common market authorised veterinary medicines may be diverted from one market to another (where the returns are higher). This can exacerbate an already critical supply situation.
- Commercial focus: Company managers must meet financial targets and this can lead to product rationalisation.
- National labelling requirements: Where the national legislation requires that national language translations or particular national requirements must be included in the product labelling, this acts as a significant deterrent as it requires that a special batch of product must be produced for that market. Where the product has a low turnover and commercial returns are small, companies will choose not to market the product in that country.
Although national legislation requires that the company marketing a veterinary medicine in Ireland must inform the HPRA at least 2 months before a product is to cease to be placed on the market (article 11(7)(b) of SI. No. 786 of 2007) there is no legal mechanism in force to compel a company to either place a product on the market or to maintain it on the market in this country. Moreover, even if it is the case that the HPRA initiatives to safeguard medicines availability in Ireland are intended to serve animal health and the public interest, the HPRA is conscious that in our role as regulator we must be objective, impartial and robust in our evaluations. The HPRA has established procedures and standards in place to ensure that our decisions are fully independent and comply with EU standards and protocols and that any conflicts of interest, real or perceived, are managed transparently.