Medicinal products for human use

Malta depends almost entirely on imported medicinals for its pharmaceutical needs. Until five years ago there was no system which had any formal control on such importation. In February 1999, the importation of medicines depended upon the submission of a certificate of pharmaceutical product (CPP) which gave some assurance on the quality, safety and efficacy of medicines in line with WHO criteria. The system was then introduced as a first step towards the introduction of a system that was in line with the much more formal and reassuring EU requirements.

During the following years the Health Division started taking the necessary measures to build the required infrastructure to be able to take on the onus of assessing the relevant documentation, such as dossiers, and be in a position to grant a market authorisation for the placing of a medicine on the Maltese market. This was possible through collaboration with the then Medicines Control Agency in London and latterly through a twinning agreement funded by the EU with the Irish Medicines Board and the Medicines and Healthcare Products Regulatory Agency (then Medicines Control Agency) in London.

In view of the fact that Malta had no form of structured system for regulating medicines, the Health Division had to provide for the enactment of the necessary legislation, restructure its Pharmaceutical Department and proceed with the recruitment and training of the necessary human resources. This had to be done while keeping in mind the public health needs and the needs of the industry. Needless to say there were significant hurdles that had to be overcome. It would suffice to say that more than a whole year was spent on negotiating the organisational changes with the Malta Chamber of Pharmacists (MCOP). During this same time, continuous dialogue was maintained with the Malta Chamber of Commerce and the Association of Pharmaceutical Importers on the effects that the introduction of regulatory measures was having on the industry.

During this same period the Medicines Act was drafted. Great care was taken to adopt the simplest systems and structures possible. The Health Division was very careful to ensure that no wheel was re-invented and that the transition system would be as smooth as possible.

The need for the introduction of such a system has indeed been confirmed by the MCOP itself. To have as smooth a transition as possible, and on the advice of the constituted bodies, the timeframes for the introduction and implementation of the registration process have been drawn out over a longer period than originally planned. Contrary to what the MCOP have said, the system being introduced is still one of a provisional marketing authorisation to be developed into a system of market authorisation over the coming two-and-a-half years. This is in line with the transition period negotiated by Malta with the EU.

The MCOP has criticised the Health Division that it did not go through a process of consultation. This cannot be further from the truth. The division has consulted with the major stakeholders throughout the process. All stakeholders that may have been interested in the legislation being proposed were invited to at least one information/discussion meeting and were asked to submit their feedback. Following this meeting the legislation was drafted and referred once again to the relevant organisations for their feedback. Following the receipt of this feedback, the final draft was completed taking into account the responses received. This has been the process for all the subsidiary legislation.

The MCOP cannot pretend to be the only interested body. A substantial proportion of the legislation did not relate to professional practice but more to industrial/trade issues and therefore the bodies relevant to these issues were consulted. The MCOP may be considered an interested party but certainly not a stakeholder in all areas.

The following quotation from a letter I received from the director general of the Federation of Industry sums up what I have stated above: "The Federation has examined these regulations and has noted with great satisfaction that many points that were presented by the federation in the course of the consultation process have been taken aboard by the authorities and given due consideration in the final versions of the regulations".

The schedule of fees that will be charged for the granting of a market authorisation were also the subject of discussion with the relevant stakeholders. The fee for the registration of medicinal products that are currently on the local market has been heavily subsidised by the government (the taxpayer). This fee, which will be paid by the manufacturers (mostly foreign) and no by the local importers, is only Lm50 and should therefore not have any justifiable impact on the price of medicinal products. The aim of the subsidy was specifically to ensure that as many medicinal products as possible would be registered.

As for the fees for new products coming on to the Maltese market after accession, these will also be borne by the manufacturers and will be absorbed in the overall cost of developing a new medicine and for placing it on the European market. It is to be remembered that the expense involved in placing a product on the market constitutes a very small proportion of the overall cost to develop a new medicine.

The number of medicines for which the Medicines Authority had a CPP and were therefore available to be placed on the local market amounts to 7,826. This is certainly a very high figure when compared to some other European countries. There is no doubt that the number of medicines on the local market will decrease but this does not mean that people will suffer. There are established mechanisms that will guarantee the availability of essential medicines that are needed. It will be possible for wholesale dealers to supply medicinal products that are not registered but are prescribed on a named patient basis in cases where there is no alternative on the market.

Moreover, the health authorities will ensure that medicines that are not registered but are considered by the same authorities to be necessary on public health grounds are available to patients. It is therefore not true that we shall not have the necessary medicines to treat the Maltese public. It may however be possible that some people will need to change from one preparation to another similar preparation for their treatment. This change will achieve the same therapeutic effect.

The aim of the Health Division is to set up a regulatory system that will guarantee to the Maltese public that the medicines on the Maltese market are of good quality, are efficacious and are above all safe. There is no doubt that in order to achieve these aims the division has had to introduce measures that were not always to the liking of the various stakeholders. Perhaps it is the introduction of such measures that is being branded as lack of consultation! In spite of all, the division will continue to work and take those decisions that are deemed to be of benefit to public health.

Dr Busuttil is Director General Health.