Mur Lura
SPEECH BY THE HON. DR. LOUIS DEGUARA, MINISTER OF HEALTH, DURING THE SEMINAR ORGANISED BY THE MEDICINES REGULATORY UNIT ON: "PATENTS, INTELLECTUAL PROPERTY, MARKET AUTHORISATION FOR MEDICINES"
pr1806
29/11/2001
29/11/2001
| It is once again a pleasure to welcome you to this two - day seminar | organised by the Medicines Regulatory Unit within the Health Division in collaboration with the Department of Pharmacy at the University of Malta. The aim of this seminar is to provide further information to all the stakeholders in the pharmaceutical sector in relation to the structures, procedures and standards that are being introduced in this sector. My presence here signifies my Government’s commitment to the introduction of regulatory mechanisms for the placing on the market, manufacture and whole sale distribution of medicinal products in Malta. |
| Since the setting up of the new Medicines Regulatory | Unit within the Division as a distinct unit outside the Government Pharmaceutical Services in July this year, significant progress has been made. Soon after its inception, the Unit organised the first seminar to give an overview of the systems that were to be introduced and dealt primarily with the aspect of good distribution practice. |
| Today’s seminar will deal primarily with the | introduction of a system of market authorisation of medicinal products. You have recently been informed of the time scale over which this system will be introduced and you have been requested to supply the Unit with details of the medicinal product you intend to place on the local market. Such information is vital for the planning and smooth implementation of the proposed system. |
| I hope that this seminar will provide you with the | necessary background information you will need to provide the Regulatory Unit with the necessary information. I also augur that the seminar will generate a constructive discussion on the subject. I have no doubt that similar seminars, addressing other aspects of the regulatory process, will be held in the future. |
| As I mentioned in my address when opening the seminar | held in July, the way forward in the health care sector today is to set up more professional and accountable systems of management allowing for the taking of quick, effective and efficient decisions. This will be achieved by changing the role of the Health Division such that it will eventually be only responsible for setting, monitoring and enforcing standards within the various facets of the health care sector. It will, of course retain its policy advisory role to Government. This change in role of the Health Division will be reflected in a new Health Services Act which is currently being drafted and which will be brought for discussion in Parliament next year. |
| Within the pharmaceutical sector the Health Division | will become the licensing Authority with the distinct role of setting standards and issuing the necessary authorisations and licences in relation to the set standards. In carrying out this function, the Health Division will be supported by an autonomous authority, the Medicines Authority which will be responsible for the technical evaluation of medicinal products as well as performing the necessary inspections related to the monitoring and enforcement of the set standards. The regulation will not only involve medicinal products, but will also cover pharmaceutical manufacturing plants, wholesale distribution as well as pharmacies. These new roles and responsibilities will also be backed by the appropriate legislation, which is currently in the very final stages of drafting and will be presented to parliament in the first quarter of next year. |
| The introduction of these new systems and the | development of the new roles to be adopted by the above structures necessitate the necessary capacity building in order to achieve the desired aims. The required steps are also being taken in this regard through the Medicines Regulatory Unit, which can be regarded as the precursor to the future Medicines Authority. The assistance of more experienced and well-established agencies with similar responsibilities overseas is being sought. For many months now, we have been negotiating an agreement with the Medicines Control Agency in the United Kingdom and we anticipate that in a short time we shall be able to conclude our negotiations. In tandem with this we are seeking to forge partnerships with other European agencies. Although discussions with these agencies are still in their early stages, we are confident that we shall also be able to secure some form of arrangement with them. |
| The phase of planning and establishing the necessary | structures to embark on this massive exercise is now mature, and the time has come for progressing with implementation. The first stage of regulation of medicinal products was implemented in February 1999, when, the submission of a Certificate of Pharmaceutical Product became mandatory for placing a medicinal product on the Maltese market. |
| We now need to move on to the second stage, which | will involve the issue of a provisional market authorisation for medicinal products currently on the Maltese market. Over a period of about five years, this will lead to a state where all medicinal products will have a market authorisation up to European standards. I have no doubt that this process will be much more taxing and will demand a significantly greater commitment form all stakeholders. This process will not only have structural and administrative implications but will also carry with it financial implications. Although all efforts are being made to keep the latter to a minimum, given the extent of the work involved these are still expected to be substantial. |
| I have no doubt we are 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. 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. |
| Regulation of the manufacturing sector and enforcing | good manufacturing practice standards started last year and we shall be proceeding with the second round of inspections this year. The same process of inspection and monitoring will next year be extended to the wholesale distribution and the pharmacy sector. This will ensure a comprehensive system that will ensure the best for our people. |
| There is no doubt that the changes that need to take | place are challenging. The purpose of today’s seminar is to generate the necessary dialogue between the regulator and the regulated. I am sure that like the July seminar, it will serve to answer many questions and at the same time raise many others. I am confident that such seminars positively promote exchange of ideas and the necessary building of a partnership between the regulatory authorities, the industry and the professionals involved in pharmaceutical activity in Malta. |
| I hope that once again you will all have a fruitful | seminar and that these two days will continue to foster a healthy co-operative partnership that will eventually result in a quantum leap in the quality of care given to the Maltese public. |
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