1. Access to Drugs Balancing Personal Autonomy and Social Justice Richard Ashcroft Imperial College London

2. A Question of Fairness What are triallists’ obligations at the end of a trial to: Trial patients? The trial population? The host country?

3. Simple Answer 1  Triallists are obliged only to provide the treatment within the trial protocol  They have no post-trial obligations at all  Any provision of Rx post-trial is purely discretionary, and subject to their other strict obligations  The issues of post-trial Rx are independent of questions of standard of care within the trial.

4. Justifications for the 1 st Simple Answer  Utilitarian: –Costs of any trial with more exacting standards are too high, so there would be no trials –Laying obligations on triallists will discourage triallists, and funders, and shift burden away from governments –All patients in the trial are better off than they would normally be, and are no worse after the trial than they were before.

5. More Justifications for the 1 st Simple Answer  It would be impossible to specify limits to these obligations which were non-arbitrary  This long term benefit would be unfair to countries or populations who were not “lucky” enough to host the trial.  Setting high standards would exclude patients who would have taken part at the lower standard, who cannot take part now because the trial has to be cancelled on cost grounds.

6. Simple Answer 2  Trial patients contribute to the triallists’ objectives; funders make a lot of money from the results; so trial patients have a right to a share in the benefits  Trial patients assume the risks in the trial, and have a right to appropriate compensation  Trial patients have an induced need for the treatment they receive in the trial (in chronic disease trials)  Therefore trial patients have a right to continued treatment after the trial is over.

7. Simple Answer 2*  The obligation to provide long term care to patients constructed by SA2 can be made more specific, in one of the following ways: –It applies to patients whichever comparison group they are in (active, placebo, innovative or standard) –It applies to all eligible patients, not just all patients actually enrolled, or not just all who complete the trial –It applies to all patients, eligible or not, in the country or region hosting the trial  These extensions are to eliminate the element of luck

8. Justifications for the 2 nd Simple Answer  Requirements of fairness-in-treatment –Avoid exploitation –Avoid unjustified unequal treatment –Meet all needs induced by the initiation of the relationship between triallist and patient (group)  Requirements of fairness-in-distribution –Allocate benefits among all who have a justified claim (not only among all those who have an ability to pay)

9. Constraints on our choice of Answer  Consistency  Other obligations to these or other groups  Limitations on responsibility of triallists (or any moral agents)  Resources  Balancing of present and future interests  Obligations of 3 rd parties (e.g. governments, sponsors, NGOs)

10. Three Central Issues  Rationality: What answer to the question of our obligations to research participants and communities best captures what it is rational to do?  Limited responsibility: Given that we are not, and cannot be required to be, moral saints, what are the limitations on our responsibilities?  Non-Exploitation: How do we avoid (avoidable) exploitation of participants and communities?

11. Rationality  Reason demands that subject to constraints such as principles of non-maleficence, beneficence, respect for autonomy, equipoise, we should do what we can to get effective treatments into use as quickly as possible. –This would be a welfare maximising proposal

12. Limited Responsibility  We are not moral saints; some strong requirements might be unreasonably stringent  Many duties are imperfect, and lie on no specific individual or organisation  Nonetheless imperfect duties are duties, and do oblige us to seek social arrangements in which they are fulfilled.

13. Non-exploitation  Exploitation: Taking unfair advantage of an individual (or group) to one’s own (or another’s) advantage.  Not all exploitation is wrong (e.g. much paid employment)  But exploitation can involve coercion, unfair distribution of risk, or direct harm.  E.g. induction of dependence; violation of personal integrity; trading on desperation.

14. A Complex Answer  Both Simple Answers have some truth in them.  No obvious analytical solution exists to the question of what justice requires of the researcher  Some guidelines: seek local agreement to the proposal; seek partnerships to ensure induced needs are met somehow after the trial is over; encourage pro-poor policies in pharmaceutical R&D in public sector and in public-private partnerships.