Dear Minister Veronesi and colleagues, my name is David Joranson. I am senior scientist and director of the Pain and Policy Studies Group and World Health Organization (WHO) Collaborating Center. I am speaking to you today from the campus of the University of Wisconsin in the USA.

I am honored to have this opportunity to encourage your efforts to decrease the regulatory barriers to the availability of opioid analgesics, so that opioids can be more easily prescribed by physicians, and more easily obtained by the patients who need them for the relief of severe pain. I would like to speak to you about regulatory impediments, and two international standards that provide strong, and unequivocal support and direction for your work to eliminate them.

First, the WHO has established an international medical standard for the treatment of pain due to cancer.1-3 The WHO Three-Step Analgesic Ladder, which Professor Ventafridda and other international experts developed approximately 15 years ago, can relieve most if not all pain due to cancer. However, effective pain relief in cancer requires the use of Essential Drugs4 like morphine and other opioids, for example fentanyl, oxycodone and hydromorphone, especially when pain is severe.

Second, there is an international regulatory standard for making opioid analgesics available. This is the 1961 Single Convention on Narcotic Drugs as amended, to which most governments, including Italy, are party. The Single Convention states at the very beginning that opioid analgesics are indispensable for the relief of pain and suffering. According to the Single Convention, national governments have an obligation not only to prevent abuse of narcotic drugs, but also to ensure their adequate availability for all legitimate medical and scientific purposes, including for the relief of pain and suffering.

Indeed, WHO uses morphine consumption statistics from each country as a general indicator of progress to relieve cancer pain in the world. In 1998, Italy's consumption of morphine for medical purposes was among the lowest in all of Europe. In the world, Italy ranked 44th.5 Looking at only these statistics, Italy's consumption of morphine is more similar to developing countries than to countries of the industrialized world.

The International Narcotics Control Board (INCB) in Vienna monitors the implementation of the Single Convention for the United Nations. In recent years, the INCB has called attention to the unavailability of opioids for medical purposes. In 1995, the INCB sent a survey to all governments in the world to determine why so many countries consumed so little opioids, in particular morphine.6 The results of the survey were very interesting.

About one-half of the governments reported they had evaluated their narcotic laws and regulations and health care systems for impediments to opioid availability. The government of Italy reported that "there were no regulatory impediments to the availability of opioids" (page 4).6 The other governments ranked fear of addiction to opioids as the greatest impediment. Tied for second place was restrictive narcotic laws and insufficient education for health care professionals. Governments also reported that one common impediment was laws that restrict the amount or number of days for the opioid prescription. In addition, about one-half of the governments reported that health professionals were reluctant to prescribe opioids because of concern about penal sanctions.

Following this survey, the INCB sent recommendations to all the governments in the world, reminding them about their responsibility to ensure adequate availability of opioids, and urging them to eliminate undue restrictions and educate health professionals about the WHO analgesic method. (For more information about international recommendations, please see our website at http://www.medsch.wisc.edu/painpolicy).

Right now, the WHO is publishing new guidelines to provide governments with a tool they can use to examine their national policies, in order to determine if they have the provisions which are needed to ensure the availability of opioid analgesics to patients.7 A special WHO work group reviewed these new guidelines. This group included the INCB, narcotic regulators from China, India and Nigeria, and pain experts from all over the world, including, I am pleased to say, Dr. Claudio Blengini from Italy.

Dear colleagues, we have been following with great interest your work to remove the now-outdated requirements which impede the use of opioids for pain relief. I understand that you are considering legislation to simplify the special prescription form. This is very important, because Italy's separate three-part form is one of the most complex in the world. I understand that the legislation would also increase the prescription amount. This too is very important; for example, Mexico's outdated 5-day restriction was recently changed to 30 days. It is my understanding that your legislation would also: make it easier for physicians to obtain the new prescription forms; reduce their fear of penal sanctions; introduce and reimburse more opioids; and provide education for health professionals and the public.

I want to emphasize that the changes you are proposing are completely consistent with what has been recommended by the health and regulatory bodies of the United Nations. They are also consistent with the recommendations of the Consensus Conference held in Bruxelles in 1992 about the need to reform narcotic control laws in Europe. Full implementation of these changes will go a long way toward the further improvement of pain relief in Italy. I hope that you will also designate a body to monitor and evaluate the results, and to recommend further changes if necessary.

Minister Veronesi, many of today's regulatory restrictions date back to the days when opioids were not well understood, and their use was limited by fear. Today, many governments are working to reduce outdated regulatory restrictions, so that national policy reflects current medical and scientific knowledge, and so that these Essential Drugs are available according to the individual needs of the patient.

I send my regards to all of you, and I wish for your success.

(1) World Health Organization. Cancer Pain Relief. Geneva, Switzerland: World Health Organization; 1986.

(2) World Health Organization. Cancer Pain Relief and Palliative Care. Geneva, Switzerland: World Health Organization; 1990.

(3) World Health Organization. Cancer Pain Relief: With a Guide to Opioid Availability. Second ed. Geneva, Switzerland: World Health Organization; 1996.

(4) World Health Organization. The Use of Essential Drugs. 8 ed. Typeset in Hong Kong; Printed in Spain: World Health Organization; 1998.

(5) Pain & Policy Studies Group. Calculations using raw data from INCB, 1999, and countries' populations.

(6) International Narcotics Control Board. Report of the International Narcotics Control Board for 1995: Availability of Opiates for Medical Needs. Vienna, Austria: United Nations; 1996.

(7) World Health Organization. Achieving Balance in National Opioids Control Policy: Guidelines for Assessment. Geneva, Switzerland: World Health Organization; 2000.