{"id":2877,"date":"2024-04-17T17:34:04","date_gmt":"2024-04-17T15:34:04","guid":{"rendered":"https:\/\/mikrobiomik.net\/improve-peoples-health-through-compassionate-use\/"},"modified":"2024-05-28T16:33:34","modified_gmt":"2024-05-28T14:33:34","slug":"improve-peoples-health-through-compassionate-use","status":"publish","type":"post","link":"https:\/\/mikrobiomik.net\/en\/improve-peoples-health-through-compassionate-use\/","title":{"rendered":"Improve people&#8217;s health through Compassionate Use"},"content":{"rendered":"[vc_row type=&#8221;in_container&#8221; full_screen_row_position=&#8221;middle&#8221; column_margin=&#8221;default&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; scene_position=&#8221;center&#8221; text_color=&#8221;dark&#8221; text_align=&#8221;left&#8221; row_border_radius=&#8221;none&#8221; row_border_radius_applies=&#8221;bg&#8221; overflow=&#8221;visible&#8221; overlay_strength=&#8221;0.3&#8243; gradient_direction=&#8221;left_to_right&#8221; shape_divider_position=&#8221;bottom&#8221; bg_image_animation=&#8221;none&#8221; gradient_type=&#8221;default&#8221; shape_type=&#8221;&#8221;][vc_column column_padding=&#8221;no-extra-padding&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;all&#8221; bottom_margin=&#8221;50px&#8221; bottom_margin_phone=&#8221;30px&#8221; column_element_direction_desktop=&#8221;horizontal&#8221; column_element_direction_tablet=&#8221;horizontal&#8221; column_element_direction_phone=&#8221;horizontal&#8221; column_element_alignment=&#8221;center&#8221; column_element_spacing=&#8221;10px&#8221; desktop_text_alignment=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_backdrop_filter=&#8221;none&#8221; font_color=&#8221;#ea5195&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; column_position=&#8221;default&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;1\/1&#8243; tablet_width_inherit=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; column_padding_type=&#8221;default&#8221; gradient_type=&#8221;default&#8221;][nectar_circle_images images=&#8221;2222&#8243; positioning=&#8221;overlapping&#8221; stacking_order=&#8221;ltr&#8221; alignment_desktop=&#8221;left&#8221; alignment_tablet=&#8221;inherit&#8221; alignment_phone=&#8221;inherit&#8221; animation=&#8221;none&#8221; image_size=&#8221;nectar_small_square&#8221; image_loading=&#8221;default&#8221;][vc_column_text css=&#8221;&#8221; text_direction=&#8221;default&#8221;]Posted by Solana Pinilla &#8211; 08\/04\/2024[\/vc_column_text][\/vc_column][\/vc_row][vc_row type=&#8221;in_container&#8221; full_screen_row_position=&#8221;middle&#8221; column_margin=&#8221;default&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; scene_position=&#8221;center&#8221; text_color=&#8221;dark&#8221; text_align=&#8221;left&#8221; row_border_radius=&#8221;none&#8221; row_border_radius_applies=&#8221;bg&#8221; overflow=&#8221;visible&#8221; overlay_strength=&#8221;0.3&#8243; gradient_direction=&#8221;left_to_right&#8221; shape_divider_position=&#8221;bottom&#8221; bg_image_animation=&#8221;none&#8221;][vc_column column_padding=&#8221;no-extra-padding&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;all&#8221; column_element_direction_desktop=&#8221;default&#8221; column_element_spacing=&#8221;default&#8221; desktop_text_alignment=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_backdrop_filter=&#8221;none&#8221; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; column_position=&#8221;default&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;1\/1&#8243; tablet_width_inherit=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221;][split_line_heading animation_type=&#8221;line-reveal-by-space&#8221; font_style=&#8221;h2&#8243; text_color=&#8221;#067078&#8243; line_reveal_by_space_text_effect=&#8221;default&#8221; content_alignment=&#8221;default&#8221; mobile_content_alignment=&#8221;inherit&#8221; link_target=&#8221;_self&#8221; text_content=&#8221;WHO: \u201cMy health, my right\u201d campaign&#8221; font_size=&#8221;2.6vw&#8221; text_direction=&#8221;default&#8221;][\/split_line_heading][vc_column_text text_direction=&#8221;default&#8221;]In an increasingly interconnected and technologically advanced world, health emerges as a fundamental pillar that supports not only individual life, but also the collective well-being of our societies. The World Health Organization (WHO), in its role as guide in the global health landscape, annually reminds us of the importance of re\ufb02ecting and acting towards the continuous improvement of health systems through the commemoration of the Day World Health. This year 2024, under the motto &#8220;My Health, My Right&#8221;, a <strong>deeply human message<\/strong>is revealed, including concepts such as access to quality health service, access to drinking water and sanitation, living with clean air, developing in a safe and healthy environment, have quality housing and have a varied diet. All these elements, together, ensure comprehensive well-being, which contributes to people&#8217;s health. This slogan not only resonates in the ears of those committed to the advancement of biotechnology and medicine, but also invites the entire global community to re\ufb02ect on how innovations in these \ufb01elds can be a vehicle to guarantee and amplify said right. Biotechnology, with its unique capacity to innovate therapies, diagnostics and healthcare solutions, plays a crucial role in realizing this right. However, it faces the constant challenge of occupying a central role in the political and social agenda of di\ufb00erent governments.[\/vc_column_text][split_line_heading animation_type=&#8221;line-reveal-by-space&#8221; font_style=&#8221;h2&#8243; text_color=&#8221;#067078&#8243; line_reveal_by_space_text_effect=&#8221;default&#8221; content_alignment=&#8221;default&#8221; mobile_content_alignment=&#8221;inherit&#8221; link_target=&#8221;_self&#8221; text_content=&#8221;Mikrobiomik focuses on improving people&#8217;s quality of life&#8221; font_size=&#8221;2.6vw&#8221; text_direction=&#8221;default&#8221;][\/split_line_heading][vc_column_text text_direction=&#8221;default&#8221;]On the occasion of \u201cWorld Health Day\u201d, from Mikrobiomik, we want to emphasize its importance. Health is more than the absence of disease; It is the integral well-being of the human being. <strong>Our commitment goes beyond research and development<\/strong>; It is rooted in the continuous improvement of the quality of life of people su\ufb00ering from various pathologies. With a highly committed team specialized in the biotechnology sector, we are dedicated to the development of izado en el sector de la biotecnolog\u00eda, estamos dedicados al desarrollo de <strong>MBK-01, a biological medicine <\/strong>based on the intestinal microbiota, which represents a promising advance in the treatment of <em>Clostridioides di\ufb03cile<\/em>infections. This bacteria, responsible for serious intestinal infections, represents a challenge in the \ufb01eld of health, especially for those patients who do not respond to conventional therapies, and reoccur from the infection, and this bacteria can become a threat to the life of the people. At Mikrobiomik, we work every day with the conviction that it is possible to make a signi\ufb01cant di\ufb00erence in people&#8217;s lives through biotechnology, always with a spirit of compassion, ethics and excellence. Because at the end of the day, what drives us is the possibility of saving lives and contributing to a healthier world. This is where our work gains value, <strong>o\ufb00ering a light of hope through the compassionate use <\/strong>, program, which is already underway for all hospitals in Spain, providing a therapeutic alternative to patients a\ufb00ected by the <em>Clostridioides di\ufb03cile<\/em> bacteria.[\/vc_column_text][image_with_animation image_url=&#8221;2853&#8243; image_size=&#8221;full&#8221; animation_type=&#8221;entrance&#8221; animation=&#8221;None&#8221; animation_movement_type=&#8221;transform_y&#8221; hover_animation=&#8221;none&#8221; alignment=&#8221;&#8221; border_radius=&#8221;none&#8221; box_shadow=&#8221;none&#8221; image_loading=&#8221;default&#8221; max_width=&#8221;100%&#8221; max_width_mobile=&#8221;default&#8221;][split_line_heading animation_type=&#8221;line-reveal-by-space&#8221; font_style=&#8221;h2&#8243; text_color=&#8221;#067078&#8243; line_reveal_by_space_text_effect=&#8221;default&#8221; content_alignment=&#8221;default&#8221; mobile_content_alignment=&#8221;inherit&#8221; link_target=&#8221;_self&#8221; text_content=&#8221;Compassionate Use Program in Spain&#8221; font_size=&#8221;2.6vw&#8221; text_direction=&#8221;default&#8221;][\/split_line_heading][vc_column_text text_direction=&#8221;default&#8221;]The compassionate use program in Spain is a regulatory framework that <strong>allows access to medications that have not yet been authorized<\/strong>, in cases where patients with serious or life- threatening diseases do not have therapeutic alternatives available. This program is based on the understanding that, in certain circumstances, the potential bene\ufb01t of an experimental treatment outweighs the risks associated with its use prior to full evaluation and approval by regulatory authorities.The legislation governing compassionate use in Spain is mainly found in Royal Decree 1015\/2009. This decree establishes the criteria and procedure for access to treatments not yet authorized, ensuring that this access is carried out in a controlled manner and based on available scienti\ufb01c evidence. The process <strong>requires a request <\/strong>from the <strong>treating physician,<\/strong> who must justify the absence of adequate therapeutic alternatives and obtain the informed consent of the patient or their legal representatives. <strong>The Spanish Agency for Medicines and Health Products<\/strong>(AEMPS) is responsible for supervising and authorizing compassionate use requests. This entity ensures that patients access these treatments safely and with adequate follow-up, evaluating information on the e\ufb00ectiveness and safety of the medication. In this way, the compassionate use program stands as a vital instrument to <strong>o\ufb00er hope <\/strong><strong>and therapeutic options to patients in critical conditions<\/strong>, within a legal framework that protects their well-being and rights. The implementation of the compassionate use program for MBK-01 in Spain has managed to bring hope to patients facing signi\ufb01cant health challenges, particularly those diagnosed with <em>Clostridioides di\ufb03cile, <\/em>o\ufb00ering a therapeutic alternative that makes a di\ufb00erence in their lives. We are proud not only to lead the \ufb01eld of microbiota, but also to ensure that our solutions are accessible to all those who need them, which so far <strong>have bene\ufb01ted 45 patients <\/strong>from di\ufb00erent hospitals in Spain, they are concrete and real cases, bene\ufb01ting from this program.At Mikrobiomik, each achievement, each advance brings us a little closer to our ultimate goal: saving lives and contributing to the global right to health.[\/vc_column_text][divider line_type=&#8221;No Line&#8221; custom_height=&#8221;50&#8243;][vc_column_text text_direction=&#8221;default&#8221;]<strong>SOURCES<\/strong><\/p>\n<p><a href=\"https:\/\/www.aemps.gob.es\/medicamentos-de-uso-humano\/acceso-a-medicamentos-en-situaciones-especiales\/uso-de-medicamentos-en-investigacion\/\" target=\"_blank\" rel=\"noopener\">www.aemps.gob.es<\/a><\/p>\n<p><a href=\"https:\/\/www.who.int\/es\/campaigns\/world-health-day\/2024\" target=\"_blank\" rel=\"noopener\">who.int<\/a><\/p>\n<p>&nbsp;[\/vc_column_text][\/vc_column][\/vc_row]\n","protected":false},"excerpt":{"rendered":"<p>[vc_row type=&#8221;in_container&#8221; full_screen_row_position=&#8221;middle&#8221; column_margin=&#8221;default&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; scene_position=&#8221;center&#8221; text_color=&#8221;dark&#8221; text_align=&#8221;left&#8221; row_border_radius=&#8221;none&#8221; row_border_radius_applies=&#8221;bg&#8221; overflow=&#8221;visible&#8221; overlay_strength=&#8221;0.3&#8243; gradient_direction=&#8221;left_to_right&#8221; shape_divider_position=&#8221;bottom&#8221; bg_image_animation=&#8221;none&#8221; gradient_type=&#8221;default&#8221; shape_type=&#8221;&#8221;][vc_column column_padding=&#8221;no-extra-padding&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;all&#8221; bottom_margin=&#8221;50px&#8221; bottom_margin_phone=&#8221;30px&#8221; column_element_direction_desktop=&#8221;horizontal&#8221; column_element_direction_tablet=&#8221;horizontal&#8221; column_element_direction_phone=&#8221;horizontal&#8221; column_element_alignment=&#8221;center&#8221; column_element_spacing=&#8221;10px&#8221;&#8230;<\/p>\n","protected":false},"author":1,"featured_media":2853,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[59,54],"tags":[56],"class_list":{"0":"post-2877","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-articles","8":"category-post","9":"tag-clostridioides-difficile-en"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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