Patient’s right in the time of the pandemic
For patients who cannot afford this medicine or who do not respond well to it, medicines outside the accepted hospital treatment protocol, or off-label medicines as they are called, can spell the difference between life and death
Published in Daily Tribune on June 4, 2021
by: Vanessa Arrha A De Leon
One controversy wrought by the current pandemic is the efficacy of existing medicines and their use in treatment outside the usual hospital protocol for Covid-19 patients.
These medicines, unlike vaccines formulated specifically for Covid-19, were developed to combat other illnesses but, through trial and error by doctors here and abroad, were discovered to have a positive effect against the virus. Consequently, they have been recommended, mostly through word of mouth, to minimize the effects of, if not cure, Covid-19.
Make no mistake, for severe and critical Covid-19 patients, battling the disease is not a simple matter of administering Covid specific medication following hospital protocol.
As with all treatments, however, even such treatment is a matter of trial and error that could entail significant expense for the patient. Remdesivir, one of the medicines used in such treatment, costs P7,000 to P8,000 per dosage and yet the World Health Organization (WHO) warned against its use for Covid patients.
For patients who cannot afford this medicine or who do not respond well to it, medicines outside the accepted hospital treatment protocol, or “off-label medicines” as they are called, can spell the difference between life and death.
But strict government regulation of such medicines, as well as the hesitancy of some doctors to prescribe them, prevent some patients from benefitting from their use, with no recourse in sight.
In the US and other countries, patients who find themselves in such situations have turned to the legal system to advocate the use of these medicines.
News in the US reports of family members of hospitalized patients going to court to gain access to these off-label medicines for the treatment of their loved ones who did not respond to hospital-approved treatments.
In India, the Indian Bar Association – a group of activist lawyers, served a legal notice upon the Chief Scientist of the WHO for the official’s act of allegedly spreading disinformation and misguiding the people of India on the effectiveness of one of these off-label medicines.
In the Philippines, what would be one’s recourse if one finds himself or herself in such a situation? With the law being unclear on the matter, one recourse would be to go through the procedure provided by the government: that is to secure a Compassionate Special Permit (CSP) from the Philippines’ Food and Drug Administration (FDA).
The same may be submitted by email to the FDA and requires the submission of the following requirements: 1.) Letter of Application; 2.) Proof of Payment; 3.) Names and Addresses of the Specialists qualified and authorized to use the product; 4.) Medical Abstract of Patient; and 5.) Prescription. However, such application for CSP would require the submission of the name of a physician who would be willing to administer such drug.
What if no physician agrees to administer or worse, what if an application for CSP is rejected? Unfortunately, the law is silent. While efforts have been made by both the House of Representatives and the Senate through legislative bills (HB 1038 and SB 2371) to enact a patient’s bill of rights and obligations that should address this concern, the same have not yet been enacted into law.
A sad truth considering the rights embodied in the said bills, could more than adequately address the gaps in existing law, providing a source of rights for affected patients.
As stated in said bills, these rights are: 1.) Right to Good Quality Health Care and Humane Treatment; 2.) Right to Dignity; 3.) Right to be Informed of His Rights and Obligations as a Patient; 4.) Right to Choose His Physician/Health Institution; 5.) Right to Informed Consent; 6.) Right to Refuse Diagnostic and Medical Treatment; 7.) Right to Refuse Participation in Medical Research; 8.) Right to Religious Belief and Assistance; 9.) Right to Privacy and Confidentiality; 10.) Right to Disclosure of, and Access to, Information; 11.) Right to Correspondence and to Receive Visitors; 12.)
Right to Medical Records; 13.) Right to Medical Records; 14.) Right to Health Education; 15.) Right to Leave Against Medical Advice; 16.) Right to Express Grievances; and 17.) Right to Self-Determination.
Out of these rights, the Right to Self-Determination, which provides that the patient has the right to avail himself or herself of any recommended diagnostic and treatment procedures, will be doubly helpful in the situations pandemic patients may find themselves in.
But until a law containing such right is enacted, we can only wait and make do with the remedies currently permitted under the law to compel a Filipino’s constitutional right to health.
