{"id":23388,"date":"2020-05-22T10:09:37","date_gmt":"2020-05-22T09:09:37","guid":{"rendered":"https:\/\/faus-moliner.com\/visita-medica-y-covid-19\/"},"modified":"2020-05-26T18:19:22","modified_gmt":"2020-05-26T17:19:22","slug":"visita-medica-y-covid-19","status":"publish","type":"post","link":"https:\/\/faus-moliner.com\/en\/visita-medica-y-covid-19\/","title":{"rendered":"Medical visits and Covid-19"},"content":{"rendered":"\n

An important and highly regulated activity<\/strong><\/p>\n\n\n\n

Medical visits are one of the main\nand most important means that pharmaceutical companies may use to provide\ninformation about their products to healthcare professionals qualified to\nprescribe or dispense them. Moreover, visits are important because they allow\ncompany representatives to collect information about the use of the medicinal\nproducts, which they must transmit to the scientific service of the company.<\/p>\n\n\n\n

Its basic legal regime is\nestablished by Royal Decree 1416\/1994 on advertising of medicinal products for\nhuman use, by which the provisions of Directive 1992\/28\/EEC (nowadays included\nin Directive 2001\/83\/EC) were transposed into Spanish law. Together with this\nbasic legal regime, several other local rules impact on medical visits in Spain.\nIn many cases, regional health authorities who are competent to organise their\nown healthcare services, have issued instructions or service orders regulating\nthe activity of medical visitors. These legal instruments have the main purpose\nof regulating the impact of medical visit in healthcare practice at hospitals.\nThe instructions normally deal with logistic issues and establish the\nconditions under which these visits may be carried out at public hospitals or\nother healthcare centres.<\/p>\n\n\n\n

The recent order approved by the\nHealthcare Department of the Basque Country on 10 February 2020 is an example\nof these norms, which must always respect the basic rules established under\nRoyal Decree 1416\/1994 and the basis for their homogenous implementation as\napproved by the Interterritorial Council of the National Health System.<\/p>\n\n\n\n

Restrictions on medical visits <\/strong><\/p>\n\n\n\n

The health alert situation created\nby Covid-19 has resulted in administrative authorities adopting exceptional\npreventive measures with the objective of protecting public health, fighting\nthe spreading of the virus and making the health system stronger. Among these\nmeasures, some authorities have restricted the activity of medical visitors.<\/p>\n\n\n\n

In view of these restrictions some\nquestions arise. Do they affect only public hospitals or also private ones? Do\nthe limitations relate to personal visits or also to on-line ones? Are these\nrestrictions necessary and proportionate?<\/p>\n\n\n\n

In respect of the first question, our view is\nthat these communications only affect healthcare professionals when acting\nwithin the sphere of competence of the administrative authority who issues\nthem. Competent authorities may prohibit medical visits to public hospitals or\nhealthcare centres under their jurisdiction, but they cannot prohibit medical\nvisits to healthcare professionals in private clinics or offices.<\/p>\n\n\n\n

As regards on-line visits, the answer is not\nblack on white. In some regions, it has been said that on-line visits fall\nunder the general concept of medical visit (for instance in the Basque country,\nwhere article 3.1 of the above mentioned Order states that “there shall be\nconsidered medical visit … all forms of electronic communication that the\npharmaceutical industry may use to offer information about its products to\nhealthcare professionals with the purpose of exerting some positive influence\nin their prescribing decisions”).<\/p>\n\n\n\n

In these cases, the restrictions to\npersonal visits may also affect on-line ones, as it happens in the Basque\ncountry. In other regions where no specific rule has been adopted, the issue\nwill require a case-by-case analysis. Neither European or national basic\nlegislation (Directive 2001\/83\/EC and Royal Decree 1416\/1994) offer any\ndefinitive answer to the question.<\/p>\n\n\n\n

This brings us to our third query. Are these\nrestrictions necessary and proportionate? In our opinion, the analysis of this\nquestion obliges us to refer to Law 25\/2009 on the freedom of access to\nservices activities and their exercise, also known as \u201cOmnibus Law\u201d. This law introduced\na general principle of great importance in our administrative legal\nenvironment. This principle is currently contained in article 4 of Law 40\/2015\nof the legal regime of the public sector, which states that \u201cpublic\nadministrations which in the exercise of their competence, establish measures\nthat limit the exercise of individual or collective rights or require the\nfulfilment of conditions in order to develop an activity, must apply the\nprinciple of proportionality and elect the measure which is less restrictive,\nmotivate its need for the protection of public interest and also justify its\nadequacy to achieve their objectives, without it being possible to establish\ndiscriminations in any case\u201d.<\/p>\n\n\n\n

In our view, any limitation of medical visits (a\nlegally recognized mechanism through which pharmaceutical companies may\nestablish relationships with healthcare professionals in order to convey\ninformation about their products and services) must be motivated and be\nproportional to the objective it aims to achieve. In this respect, authorities\nmust be very careful and should avoid that restrictions that may be in place\nduring the pandemic with the purpose of protecting public health remain in\nforce beyond this period.<\/p>\n\n\n\n

E-communications and privacy<\/strong><\/p>\n\n\n\n

It is a fact that electronic communications\nbetween industry and healthcare professionals are going to have special\nrelevance in the future.<\/p>\n\n\n\n

In this context we should not forget that\ncompanies may only send electronic promotional communications to those\nhealthcare professionals who have expressly agreed to receive them. The consent\nof the healthcare professional is a key element to ensure that promotional\ncommunications comply with applicable law. How must this consent be? This is a\nquestion that has recently created a lot of interest in healthcare professionals,\nmost of which have little time to dedicate to medical visitors and whose e-mail\ninboxes are full of e-mails.<\/p>\n\n\n\n

Under the rules that govern personal data such as\nthe GDPR and Law 3\/2018 on the protection of personal data, consent must be\nunequivocal and must be expressed through a clear affirmative action or\ndeclaration. the rule is that only a “YES” is a “YES”. It\nis necessary to get a \u201cYES\u201d to assert the existence of consent. On the contrary,\nit is not acceptable to rely on tacit consent (i.e. send a communication,\nalerting the recipient that absence of a negative answer from the professional\nwill be understood as consent to receive commercial communications).<\/p>\n\n\n\n

At European level, the European Data Protection Board has recently\nissued guidelines 05\/2020 on consent on\nthe regulation 2016\/679.<\/p>\n\n\n\n

These\nguidelines which are an update of the ones that Article 29 Working Party\nadopted in the past, confirm the abovementioned criteria.  In this sense the EDPB states the following:<\/p>\n\n\n\n

\u00b7 The consent must \u201cbe obvious\u201d;<\/p>\n\n\n\n

\u00b7 The use of opt-in boxes is valid\n(e.g. if you consent, tick X in the following box);<\/p>\n\n\n\n

\u00b7 The use of pre-ticked opt-in boxes\nis invalid (e.g. if you do not consent, untick the X from the following box);<\/p>\n\n\n\n

\u00b7 The silence or inactivity of the subject\ncannot be regarded as a valid form of consent.<\/p>\n\n\n\n

Therefore\nobtaining unequivocal and express consent from healthcare professional is\nnecessary to send promotional communications to them, it not being possible to\nrelax this requirement at any time, not even in the present situation\noriginated by Covid-19.<\/p>\n","protected":false},"excerpt":{"rendered":"

An important and highly regulated activity Medical visits are one of the main and most important means that pharmaceutical companies may use to provide information about their products to healthcare professionals qualified to prescribe or dispense them. Moreover, visits are important because they allow company representatives to collect information about the use of the medicinal… <\/p>\n

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