SPEECH BY THE MINISTER OF HEALTH DR LOUIS DEGUARA, AT THE INAUGURATION OF A SEMINAR ON "REGULATORY FRAMEWORK AND PRACTICAL IMPLEMENTATION OF GOOD DISTRIBUTION PRACTICE OF PHARMACEUTICAL PRODUCTS" – QAWRA - 30 JULY, 2001

It is indeed a great pleasure to welcome you to this one day seminar organised by the Health Division in collaboration with the Department of Pharmacy at the University of Malta. The aim of this seminar is to provide the necessary basic background to all interested parties in the developments that are taking place or will be taking place in the near future in the pharmaceutical field.

Over the past decade my Government has been committed to reforming the health sector. The initial reforms in 1992 involved the decentralisation and devolution of power and responsibility from what was then the Department of Health to the setting up of a Health Division with a number of Departments responsible for various health care services. With the changes that are taking place in the health care sector today, there is now need to proceed with the second stage of reform, which would allow for a more professional and accountable system of management giving it the ability to take quick, effective and efficient decisions. This will be achieved by the Health Division relinquishing its role as service provider and adopting a role of policy adviser to Government. The Health Division will also be responsible for regulating the performance of autonomous service providers and establishing, monitoring and enforcing standards of health care in Malta.

These reforms currently taking place within the health sector are therefore based on three fundamental Government policy decisions:

• The separation of the regulatory and operational functions of the Health Division
• The building of the new hospital with the introduction of hospital autonomy and the development of more effective and efficient management systems
• The preparations for Malta’s accession to the European Union

The Health Division has for the past months been striving to implement these policy decisions through a number of initiatives:

• A total review of its organisational structure such that it will be in a position to effectively take on its new role of adviser to Government and regulator of all health care services
• A review of management systems with the introduction of new systems in preparation for the split between operator and regulator and the eventual introduction of hospital autonomy
• A massive exercise of drafting of new legislation to back up these changes and update the existing antiquated legislation.

In the Pharmaceutical field, the Health Division (Department of Health) has for many years been the policy maker, operator, service provider and regulator of pharmaceutical activity in Malta. In the last years, most of these functions and responsibilities have been to a large extent assumed by the Government Pharmaceutical Services. In line with the policy direction given by Government, it has been felt necessary to reform the structure and function of the Government Pharmaceutical Services.

Following prolonged discussions with the Malta Chamber of Pharmacists it has been agreed that the Policy making function should now reside within the reformed Health Division with the setting up of a new Pharmaceutical Policy and Audit unit. A special task force has been established to take on the regulatory functions. The aims of this Task Force, which will be referred to as the Medicines Regulatory Unit, are to implement the necessary systems for the effective regulation of pharmaceuticals and pharmaceutical activity.

The functions of this Unit will eventually be taken over by an autonomous Medicines Regulatory Authority, which will be set up next year following the enactment of the relative legislation. The operational functions, previously carried out by the National Formulary Management Unit within the Government Pharmaceutical Services is currently undergoing an exercise of Business Process Re-engineering with the help of professional consultants specifically contracted for the purpose. The service provision to patients will eventually move to the autonomous hospitals.

I believe that the major changes that need to take place are within the regulatory component. I am sure that we are all in agreement that systems which ensure the highest standards of quality, safety and efficacy of pharmaceuticals on our market need to be introduced and the established standards rigorously enforced.

The first step towards the achievement of this aim was the introduction of a registration system for Certificates of Pharmaceutical Products in February 1999. The next step over the coming weeks will be the introduction of a provisional licensing system which will over a number of years be replaced by a full system for market authorisation of medicinal products.

Ensuring that all pharmaceuticals on the Maltese market are of the highest quality, while a desired achievement in its own right, is not sufficient to ensure the best possible care to the public. Standards in respect of the storage, distribution and dispensing of medicines need to be established and the necessary mechanisms to implement, monitor and enforce such standards will need to be established. We have to clearly identify the good and not so good elements in our practices today and while consolidating and building on the good elements, we have to change or discard the bad ones. This exercise will have to be undertaken by both the private and the public sector who will both be under the scrutiny of the Regulatory Authority.

The aim of today’s seminar is to introduce the principles underlying the above regulatory framework. There is no doubt that the changes that need to take place are challenging and stimulating. They will be construed as threats by some, others will regard them as an opportunity to develop, expand and professionally mature. We feel it is important that all stakeholders are well informed and briefed of the systems to be introduced and their role in their implementation. Moreover, this seminar, and others that will be held in the future, should serve as a forum for exchange of ideas and the building of a partnership between the regulatory authorities, the industry and the professionals involved in the activity.

I hope that you will all have a fruitful seminar and that the end of today’s work will mark the beginning of a healthy co-operative partnership that will eventually result in a quantum leap in the quality of care given to the Maltese public.