14th General Assembly and 5th Asia Pacific Regional Conference (Tokyo, 12-16 November 2002)
Keynote address by Dr Delon Human, Secretary Genera, World Medical Association, Ferney-Voltaire, France
To be delivered on Thursday, 14 November 2002 during 10:15-11:00 a.m. session

Mr Chairman,

I should like to start by thanking the World Self-Medication Industry and the hosts of this Conference, the Proprietary Association of Japan, for inviting me to attend and to deliver a Keynote Address. I am both honoured and privileged to do so, and I am delighted to be sharing the platform with a senior and very distinguished staff member of WHO, Dr Anarfi Asamoah-Baah. He will be presenting WHO's views on self-medication in health policy while I shall endeavour to present the standpoint of the Association of which I have the honour to be Secretary General, the World Medical Association. We are based on the French border with Switzerland, only a few minutes from WHO, and I am pleased to say that in recent years the cooperation not least in the pharmaceutical sector, between our organizations has been extremely close and productive. The WMA today is made up of some 80 National Member Associations and it is no exaggeration to say that the WMA represents some 7 to 8 million practising physicians.

May I take this opportunity to acknowledge the very important contributions to our work made by the Japan Medical Association and its eminent President, Dr Eitaka Tsuboi, whom we had the privilege of hearing just a few minutes ago. Dr Tsuboi served as the President of the WMA from 1999 to 2000 and I speak for all of our Members when I say that he occupied this post with great distinction. The Japan Medical Association is a very active and productive member of our Association and I am confident that this happy state of affairs will continue in the years to come.

I have come to this Conference not only to speak but also to learn - to learn about self-medication in today's complex health, medical and pharmaceutical environment. I am particularly pleased that I and other participants will have an opportunity to learn about global perspectives in self-medication - from experts such as my friend Dr Jerry Reinstein, the Director-General of the WSMI, and Mr Thomas Blinn, the incoming Chairman of the WSMI. But we shall also have an unequalled opportunity to hear a range of speakers on prospects and problems in self-medication in Japan, China and other countries in the Asia-Pacific Region.

Ladies and Gentlemen, Distinguished Participants, let me point out that one of the key roles of the WMA is to develop and formulate resolutions, statements, and declarations on ethical and policy matters that affect the practice of medicine. In a few minutes I shall talk about the WMA Statement on Self-Medication. Before doing so, let me emphasize the importance we attach to the Declaration of Geneva, a sort of modern re-statement of the Hippocratic Oath of antiquity. I will not dwell in detail on its provisions but perhaps I should mention the provision which affirms that "The health of my patient will be my first consideration." In today's constantly changing world, the physician would be the first to acknowledge that self-medication combined, where appropriate, with the judicious use of prescription medicines, constitutes, in many contexts, the way to better health for patients. I should mention that the Declaration of Geneva was first adopted by the WMA in 1948 and was most recently amended in 1994.

A second, highly important, Declaration is that of Lisbon on the Rights of the Patient. First adopted in 1981, the Declaration of Lisbon has been amended on only one occasion, in 1975. The Declaration states in its Preamble that it "represents some of the principal rights of the patient which the medical profession endorses and promotes." "Physicians and other persons or bodies involved in the provision of health care have a joint responsibility to recognize and uphold these rights." Clearly, the term "other persons or bodies" includes persons dispensing OTC drugs or other products used in self-medication.

Let me turn now to the "Proposed WMA Statement on Self-Medication". I say "Proposed" because at the time of drafting today's presentation, in mid-September, the text had not yet been adopted. I firmly anticipate that the statement will be adopted at our General Assembly in Washington, DC, being held in early October. The process which led to the drafting of this statement was initiated in 1999 jointly by the WMA and the WSMI.

What does the Statement say? I propose to illustrate some of the most important points by a series of PowerPoint slides.

The Preamble declares simply that the WMA has developed the Statement to provide guidance to physicians and their patients regarding responsible self-medication. Section I deals with the distinction between self-medication and prescription medicine. You will see that it is, under para I.I, the responsibility of the national authorities to ensure that non-prescription medicines are sufficiently safe not to be harmful to health. Point 1.3 defines "responsible self-medication" for the purposes of this document. It is interpreted to mean the use of a registered or monographed medicine legally available without a physician's prescription either on an individual's own initiative or following the advice of a healthcare professional. The use of prescription medicine without a prior medical prescription is not part of responsible self-medication. The final paragraph of this section affirms that the safety, efficacy and quality of non-prescription medicines must be proved according to the same principles as prescription medicines.

Section 2 deals with the use of self-medication in conjunction with prescription medication, either concurrently or sequentially. The patient must be informed about possible interactions between prescription medicines and non-prescription medicines. He or she should consequently be encouraged to inform the physician about his or her self-medication.

Section 3 deals with "Roles and responsibilities in self-medication." This Section includes numerous important provisions and defines the respective responsibilities of the individual using self-medication products, of health professionals caring for patients, of manufacturers, and of pharmacists. The latter have a professional responsibility to recommend, in appropriate circumstances, that medical advice should be sought. One paragraph, 3.4, is addressed to all parties involved in self-medication. They should, it is stated, be aware of the benefits and risks of any self-medication product; the benefit-risk balance should be communicated in a fair, rational manner without overemphasizing either the risks or the benefits. There is a particularly important obligation incumbent upon pharmacists - that of referral. The relevant provision lays down that the pharmacist has a professional responsibility to recommend, in appropriate circumstances, that medical advice should be sought - a provision that underlines the complementary roles of pharmacists and physicians in regard to self-medication.

Section 4 - on the role of governments in self-medication - consists of a single sentence but it is an important one. Governments, it is stated, should recognize and enforce the distinction between prescription and non-prescription medicines. They have a responsibility to ensure that the users of self-medication are well informed and protected from possible harm or negative long-term effects.

Finally, there is a Section on the promotion and marketing of self-medication products. I do not think I need to dwell on its provisions in full. Let me just quote one sentence; I quote: "Promotion and marketing should not encourage irresponsible self-medication, purchase if medicines that are inappropriate, or purchases of larger quantities of medicines than are necessary."

The distinguished members of the self-medication industry will, I am sure, be aware of, and fully comply with, the provisions on advertising in this final Section 5 of the Statement.

Let me emphasize again that this speech, in the form contained in the convention proceedings, was composed prior to our recent Washington General Assembly. However, being aware of the careful way in which this particular Statement was drafted and discussed in various WMA fora prior to its submission to the General Assembly in Washington, I am rather confident that my oral presentation in Tokyo will truly reflect the final version of what I consider to be an important, timely Statement of great significance to all health professionals, and in particular physicians and pharmacists.