Understanding Ozone Therapy and Adhering to Globally Recognized Guidelines

Ozone Therapy is backed by Science

Recognizing the global landscape of Ozone Therapy, we at OzonMed Wellness Clinic, Inc., we have adopted the criteria set by the International Scientific Committee of Ozone Therapy (ISCO3) (2020), as outlined in the Madrid Declaration on Ozone Therapy, 3rd Edition, which serves as the standard for unification of criteria in the practice of Ozone Therapy.

The main objectives of ISCO3 are as follows:

1)    To determine the scientific and medical merits of each particular application of ozone, as well as a code of good practice, in order to create a standard practice and prevent the possibility of malpractice;

2)    To standardize each particular application of ozone based on scientific evidence.

This international standard signifies our commitment to achieving excellence in the application and utilization of Ozone Therapy treatment, fostering its global acceptance. Adhering to these standards demonstrates our dedication to integrating best practices in healthcare through Ozone Therapy treatment. By incorporating globally recognized guidelines into our practice, we affirm our belief in the benefits of Ozone Therapy and our pledge to provide advanced treatments to our patients in the Philippines.

The scientific foundations of Ozone Therapy, as approved by the International Scientific Committee of Ozone Therapy (ISCO3), were published on November 18, 2012. A copy is attached as Annex "J", hereto.

At OzonMed Wellness Clinic, Inc., we are fully committed to upholding the highest standards of patient safety and regulatory compliance in the application of Ozone Therapy. This treatment has gained significant attention and success in various European countries.

Given that Ozone Therapy is a new practice in the Philippines and lacks specific regulations, we deemed it prudent to provide background information on its history, its legal status in Europe and other countries, and the Philippine legislation supporting alternative, complementary, or integrative medicine through the use of Ozone Treatment modalities.

HISTORICAL BACKGROUND OF OZONE THERAPY

The historical background of Ozone Therapy is extensive, spanning several centuries from its discovery to its modern medical applications. Initially recognized for its potent oxidizing properties by Dutch physicist Martin van Marum in 1785, ozone's medical potential was first suggested by Christian Friedrich Schönbein in the 19th century. Early technical applications, such as Werner von Siemens's ozonization device in 1857, paved the way for its use in water purification and later medical therapy.

The late 19th and early 20th centuries witnessed a surge in interest and application of Ozone Therapy, particularly in Germany, Russia, and the United States. Innovations such as Joachim Hansler's first ozone generator and various administration methods, including injections and rectal insufflation, were developed. Notably, Ozone Therapy was used during the First World War to treat wounds, gangrene, and tetanus.

Despite its increasing application, Ozone Therapy faced significant challenges, notably from the American Medical Association (AMA) in the early 20th century, leading to a decline in its use in the United States. However, a revival occurred in the mid-to-late 20th century, with pioneers like Dr. Hans Wolff and Dr. Renate Viebahn advancing the therapy's understanding and application, particularly in Germany.

In recent decades, the scientific foundation and application of Ozone Therapy have expanded significantly, gaining international recognition and regulatory acceptance in countries such as Russia, Cuba, and parts of Spain and Italy. The therapy is noted for its simplicity, effectiveness, and minimal occurrence of side effects. Modern research has highlighted ozone's immunomodulating, anti-inflammatory, bactericidal, antiviral, and analgesic properties, expanding its clinical indications.

The establishment of international scientific committees and associations, along with the publication of guidelines and the Madrid Declaration on Ozone Therapy, reflects ongoing efforts to standardize practices and gain broader acceptance within the medical community. Despite challenges, continued research, clinical successes, and growing professional networks suggest a promising future for the therapeutic use of ozone.

LEGAL STATUS OF OZONE THERAPY IN OTHER COUNTRIES

While there is currently no existing law in the Philippines regulating the practice of Ozone Therapy, the practice has been regularized in several other countries. Ozone Therapy has been regularized in the following 17 countries: Greece (1991, 2014), Ukraine (2001, 2014), Italy (in regions such as Lombardy, Emilia-Romagna, and Marche), China (2005), Russia (2005, 2007), Spain (between 2007 and 2012, through Directives issued in autonomous communities), Cuba (2009, 2015), Sultanate of Oman (2010), Emirate of Dubai of the United Arab Emirates (UAE) (2011), Portugal (2013- 2018), Turkey (2014), Brazil (Dentistry in 2015, Medicine in the public health sector in 2018), and Mexico (in the state of Nuevo León in 2018), Egypt, Honduras, Germany and the United States of America (USA in 15 Federal States).

GERMANY

Freedom of Therapy

The practice of Ozone Therapy originated in Germany, and it boasts the highest number of ozone therapists globally. In 2011, there were 11,000 medical therapy practitioners in the country, a number that has likely increased significantly in the years since.

Due to Germany's policy of "freedom of therapy", Ozone Therapy can be practiced without restrictions in Germany.

Reason why Ozone Therapy can be practiced without restrictions in Germany

The German drug and medical products supervisory body, the Federal Institute for Pharmaceuticals and Medical Products (Bundesinstitut für Arzneimittel und Medizinprodukte), explained that in Germany, there is the principle of "freedom of therapy". This means that a product does not necessarily need authorization as a medicine to be selected by a doctor as therapy for a patient (Mariño, R. Q., 2021, December 19).

UNITED STATES OF AMERICA

The FDA and OZONE

According to Bocci, the expanded dogma in the U.S. that "ozone is always toxic and should not be used in medicine" is an absurd and unscientific idea, and today we have numerous reasons for saying that it is completely wrong. 

It is disappointing that some influential American scientists still believe that it is correct. The FDA decision has negatively influenced the Health Authorities of other countries, which is not surprising because today only a few super developed countries have a dominant influence over the world's medical resources.

Health Freedom States

As the FDA has jurisdiction over the entire U.S., the assertion of Bocci has fallen short. They alleged that Ozone Therapy is forbidden in the U.S. This statement however, is not true at all. There are significant limitations regarding how health laws are enforced in various states of the United States. As this country has a federal structure, each state has certain powers to legislate on authorized matters.

In accordance with the Foundation for the Advancement of Innovative Medicine (FAIM), they found 15 Federal states that observe the policy of "Health Freedom” divided into three categories:

1. States with laws that protect patient access to “alternative therapies”

practiced by licensed physicians:

Alaska, Colorado, Georgia, Indiana, Massachusetts, New York, North Carolina, Ohio, Oklahoma, Oregon, Texas and Washington.

2. States with laws that protect patient access to “alternative therapies”

practiced by all licensed professionals in health care:

 

Florida.

3. States with regulations protecting patient access to “alternative therapies”

by licensed Physicians:

Louisiana, Nevada, and Texas.

Health freedom legislation – non-discrimination for alternative medicine

The comparative law analysis for the 15 Federal states conducted by Schwartz et al. was made on six specific themes: Definitions of non-conventional medicine and/or alternative medicine and/or complementary and/or integral; persons authorized to practice unconventional medicine; sanctions for physicians; patient rights; informed consent; participation in state medical boards; and non-discrimination for alternative medicine.

Ozone Therapy can be practiced in 15 U.S. states. Although ozone is not a drug approved by the Food and Drug Administration (FDA), the legal analysis showed that non-allopathic medicine can be used in the following 15 U.S. states: Alaska, Colorado, Florida, Georgia, Indiana, Louisiana, Massachusetts, Nevada, New York, North Carolina, Ohio, Oklahoma, Oregon, Texas, and Washington. No regulation in the fifteen states about Ozone Therapy. However, Ozone Therapy may be used in 15 U.S. states, under the Health Freedom Laws - named for the Foundation for the Advancement of Innovative Medicine (FAIM) - to be used and practiced as non-conventional therapy.

The practice of Ozone Therapy however will be subject to the specific regulations of each of the 15 states. Essentially, these requirements can be summarized in two parts:

1.     The therapy is to be practiced by a medical professionals licensed to practice

the profession and with skills in the use of Ozone Therapy.

2.     Preparation of an informed consent that varies from state to state, where - among other points - the type of treatment to be done is specified.

PHILIPPINE LEGISLATION/LAW THAT SUPPORT ALTERNATIVE HEALTH CARE MODALITIES

Here in the Philippines, there is currently no existing law that regulates the practice of Ozone Therapy. However, we have existing legislation that supports the use of Alternative Health Care under Republic Act No. 8423, otherwise known as the Traditional and Alternative Medicine Act (TAMA) of 1997.

Under Section 2, Declaration of Policy of the said law states that:

It is hereby declared the policy of the State to improve the quality and delivery of health care services to the Filipino people through the development of traditional and alternative health care and its integration into the national health care delivery system.

xxxxx

Section 3 also laid down the objectives of the said law:

a.     To encourage scientific research on and develop traditional and alternative health care systems that have direct impact on public health care;

b.     To promote and advocate the use of traditional, alternative, preventive and curative health care modalities that have been proven safe, effective, cost effective and consistent with government standards on medical practice;

c.     To develop and coordinate skills training courses for various forms of traditional and alternative health care modalities;

d.     To formulate standards, guidelines and codes of ethical practice appropriate for the practice of traditional and alternative health care as well as in the manufacture, quality control and marketing of different traditional and alternative health care materials, natural and organic products, for approval and adoption by the appropriate government agencies;

e.     xxxxx;

f.     To formulate policies to strengthen the role of traditional and alternative health care delivery system; and

g.     To promote traditional and alternative health care in international and national conventions, seminars and meetings in coordination with the Department of Tourism, Duty Free Philippines, Incorporated, Philippine Convention and Visitors Corporation and other tourism-related agencies as well as non-government organizations and local government units.

Furthermore, Section 4 defined Alternative Health Care Modalities

xxxxx

d. "Alternative health care modalities" — other forms of non- allopathic, occasionally non-indigenous or imported healing methods, though not necessarily practiced for centuries nor handed down from one generation to another. Some alternative health care modalities include reflexology, acupuncture, massage, acupressure, chiropractics, nutritional therapy, and other similar methods.

Given that Ozone Therapy is practiced in numerous countries and authorized under the Health Freedom Laws in 15 states in the U.S., we assert that Ozone Therapy falls within the definition of Alternative Health Care Modality as outlined in paragraph d of Section 4 of Republic Act No. 8423, also known as the "Traditional and Alternative Medicine Act of 1997." This is because Ozone Therapy is a non-allopathic, non- conventional, alternative, complementary, or integrative modality widely practiced in Europe, same parts of Asia, the United States and in South America.

As an integrative healthcare and wellness practitioner, I view Ozone Therapy as complementary or adjunctive to conventional treatment methods. However, it serves as an alternative modality for patients who opt out of chemotherapy or radiation therapy, in the exercise of their right to choose their treatment modality.

Patient’s right to choose treatment modality

In the Philippines, patients' rights, including the right to choose their treatment modality, are recognized and protected under various healthcare laws and policies. While there isn't a specific law exclusively dedicated to patients' right to choose their treatment modality, the broader framework of patient rights in the Philippines encompasses this right within the principles of informed consent and patient autonomy.

The right to informed consent is pivotal, ensuring that patients are fully informed about their medical condition, treatment options, risks, benefits, and alternatives before undergoing any medical intervention. This principle supports patients' autonomy in making informed decisions about their healthcare, including the choice of treatment modality.

Furthermore, legislative efforts, such as Senate Bill No. 1534, the Patients' Bill of Rights and Responsibilities Act, aim to bolster patient rights, including those of underprivileged groups. This bill seeks to empower patients by making them aware of their rights and available remedies, emphasizing continuity of appropriate and high-quality healthcare without discrimination. It explicitly acknowledges the patient's right to select their physician or health institution and seek a second opinion, highlighting the significance of patient choice in the healthcare process.

These legal frameworks collectively emphasize the importance of respecting patient autonomy, including the right to choose one's treatment modality, within the framework of informed consent and ethical medical practice in the Philippines.

Based on the above, patients have the right to choose their treatment modality under the guidance of their chosen medical practitioner. They may opt for conventional, alternative/non-allopathic, or traditional treatment modalities, as provided for in Republic Act No. 8423, the Traditional and Alternative Medicine Act of 1997.

How cancer is being treated in the Philippines

In the Philippines, the conventional or standard treatments for cancer are similar to those in many other countries and typically include:

Surgery: Surgical removal of the tumor is often the initial treatment for solid tumors that are localized and operable.

Chemotherapy: Chemotherapy involves the use of drugs to kill cancer cells or stop them from growing. It is often used in combination with surgery or radiation therapy.

Radiation Therapy: Radiation therapy uses high-energy rays to kill cancer cells.

It can be used alone or in combination with surgery and chemotherapy.

Targeted Therapy: Targeted therapy uses drugs or other substances to specifically target cancer cells while causing less harm to normal cells. It works by interfering with specific molecules involved in tumor growth and progression.

Immunotherapy: Immunotherapy works by stimulating the body's immune system to recognize and attack cancer cells. It can be used to treat various types of cancer and is often used when other treatments have failed.

Hormone Therapy: Hormone therapy is used to treat cancers that are hormone- sensitive, such as breast and prostate cancer. It works by blocking the production or action of hormones that fuel cancer growth.

Palliative Care: Palliative care focuses on providing relief from the symptoms and stress of cancer. It aims to improve the quality of life for patients and their families through pain management, symptom control, and emotional support.

Treatment through Ozone Therapy as complementary or integrative modality

Some clinical conditions treated by Ozone Therapy as a Complementary Therapy are as follows:

Chronic infections: Ozone has been suggested as a treatment for chronic viral, bacterial, and fungal infections. It's believed to have antimicrobial properties that may help in combating these infections.

Wound healing: Some studies suggest that ozone therapy may aid in wound healing by improving blood circulation and oxygenation of tissues.

Arthritis: Ozone injections into joints have been explored as a treatment for various forms of arthritis, including osteoarthritis and rheumatoid arthritis. Proponents claim that ozone may reduce inflammation and pain associated with these conditions.

Autoimmune diseases: There are anecdotal reports and some studies exploring the use of Ozone Therapy in autoimmune diseases such as multiple sclerosis and lupus. It's believed to modulate the immune system, although more research is needed to establish its efficacy and safety.

Chronic pain: Ozone injections, particularly into areas of chronic pain such as the back or joints, have been suggested as a treatment to alleviate pain. It's thought to work through its anti-inflammatory and analgesic effects.

Cancer: Ozone Therapy has been proposed as an adjunctive treatment for cancer. Ozone Therapy enhances the effects of conventional cancer treatments like chemotherapy and radiation therapy, while others suggest it has direct anticancer effects.

Cardiovascular diseases: Ozone therapy has been explored as a potential treatment for cardiovascular diseases, including atherosclerosis and peripheral artery disease. Ozone improves blood circulation and oxygen delivery to tissues.

Chronic obstructive pulmonary disease (COPD): Some studies have investigated the use of Ozone Therapy in COPD, suggesting that it may improve lung function and reduce inflammation in the airways. However, more research is needed to confirm these findings and determine the safety and efficacy of Ozone Therapy in COPD treatment.

Benefits of Medical Ozone Therapy:

1. Treatment for various diseases including cancer, hypertension, diabetes, arthritis, and pain.

2. Inactivation of harmful microorganisms such as bacteria, viruses, fungi, protozoa, parasites, and cancer cells.

3. Activation of the immune system, enhancing healing processes.

4. Stimulation of protective cell enzyme production.

5. Oxidation and elimination of toxins.

6. Normalization of hormone and enzyme levels.

7. Heavy metal chelation, especially effective with EDTA.

8. Alleviation of pain and nerve calming.

9. Enhancement of brain function and memory.

10. Purification of blood and lymphatic systems.

11. Reduction of cardiac arrhythmias (malfunctioning of beating of the heart).

12. Dissolution of malignant tumors.

13. Prevention of stroke damage Cerebrovascular disease.

14. Neutralization of free radicals.

15. Reduction of inflammation.

16. Control of bleeding and prevention of shock.

PHILIPPINE ACADEMY OF OZONOTHERAPY, INC.

The undersigned serves as the President and one of the Founding Directors of the PHILIPPINE ACADEMY OF OZONOTHERAPY, INC., a registered entity before the Securities and Exchange Commission (SEC) with Company Registration No. 2021090024444-23. The purposes of the said academy are as follows:

a)    To establish standards for the art and science of ozone therapy, to educate the public and other health professionals about the many uses of ozone therapy in medicine, and to promote

research in ozone therapy. To enhance the health and well-being of people through this safe, inexpensive, and effective therapy;

b)    To assist in the preparation of research studies, recommendations, projects, specific activities of the Philippine Academy of Ozonotherapy (PAO), its members, press releases, and any legislative actions affecting ozone therapy;

c)    Define and standardize the application and use of ozone therapy in specific disease and conditions;

d)    Approve and support protocols for the application of ozone therapy;

e)    Establish, maintain and promote contact and collaboration with national and international institutions of similar nature and purpose;

f)     Standardize and certify training programs in ozone therapy;

g)    To publish and disseminate research conducted by the Philippine Academy of Ozonotherapy (PAO) or by others in the international ozone community giving priority to PAO members;

h)    To promote, sponsor, organize and conduct meetings, symposia, workshops, seminars and the like, both nationally and internationally for the achievement of the purposes of the PAO. These activities may be held jointly with other organizations that share similar interests;

i)     To defend members and the use of ozone therapy before regulatory authorities and news agencies to the extent that it is able. The PAO recognizes that all legal costs for the defense of any member shall be borne by the member;

j)     To obtain public, private, national and international funding to advance the scientific

In light of the aforementioned, we aim to import medical devices for use in our clinic and training purposes and for the use of the Philippine Academy of Ozonotherapy, Inc. in collaboration with PITAHC under R.A. No. 8423, otherwise known as the Traditional and Alternative Medicine Act (TAMA) of 1997.

We acknowledge the potential of Ozone Therapy to significantly improve the quality of life for patients facing conditions with limited treatment options. Our dedication and goal is to provide patients access to cutting-edge medical treatments within a safe and regulated framework. Furthermore, as the Medical Director of OzonMed Wellness Clinic, Inc. and as President of the Philippine Academy of Ozonotherapy, Inc., I am committed to contribute to the body of evidence supporting the efficacy and safety of

Ozone Therapy. Through research and collaboration, we aim to assist regulatory bodies in making informed decisions regarding the approval and integration of Ozone Therapy into mainstream healthcare in the Philippines. The expanding market for Medical Ozone Therapy, both from local and foreign clients, will make a significant contribution to boosting our economy.

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Ozone therapy in the Philippines